<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03774875</url>
  </required_header>
  <id_info>
    <org_study_id>CC-10004-PSOR-020</org_study_id>
    <secondary_id>U1111-1224-8381</secondary_id>
    <secondary_id>2018-002850-58</secondary_id>
    <nct_id>NCT03774875</nct_id>
  </id_info>
  <brief_title>A Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Adults With Manifestations of Plaque Psoriasis and Impaired Quality of Life</brief_title>
  <acronym>EMBRACE</acronym>
  <official_title>A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to assess the impact of treatment with apremilast 30 mg&#xD;
      twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in&#xD;
      adults with manifestations of plaque psoriasis and impaired quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized 2 (apremilast):1 (placebo) in approximately 10 countries in&#xD;
      Western Europe. Participants will be block-randomized to each of the manifestations of&#xD;
      psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and&#xD;
      psoriasis in visible locations). Participants presenting with multiple manifestations will be&#xD;
      allocated to the manifestation which is most severe, as determined by the participant. All&#xD;
      manifestations will be assessed for efficacy at each study visit.&#xD;
&#xD;
      The study will consist of 4 phases:&#xD;
&#xD;
        -  Screening Phase - up to 5 weeks (35 days)&#xD;
&#xD;
        -  Double-blind Placebo-controlled Phase - Weeks 0 to 16 Participants will receive&#xD;
           treatment with either apremilast or matched placebo.&#xD;
&#xD;
        -  Apremilast Extension Phase - Weeks 16 through 52 All participants will be switched to&#xD;
           (or continue with) apremilast at week 16 and will maintain this dosing through week 52.&#xD;
&#xD;
        -  Post-treatment Observational Follow-up Phase 4-week post-treatment observational&#xD;
           follow-up phase for all participants who complete the study on treatment or discontinue&#xD;
           from the study treatment early.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">November 3, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DLQI at Week 16</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot;), which equates to approximately 1% of total BSA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.&#xD;
A negative change from baseline indicates improvement in itch severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.&#xD;
A negative change from baseline indicates improvement in skin discomfort/pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score &lt; 3 at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (16 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in EQ-5D Index Score at Week 16</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.&#xD;
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment</measure>
    <time_frame>Baseline and week 16</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period</measure>
    <time_frame>From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period.</time_frame>
    <description>An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.&#xD;
A serious adverse event (SAE) is any AE occurring at any dose that:&#xD;
Resulted in death;&#xD;
Was life-threatening;&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization;&#xD;
Resulted in persistent or significant disability/incapacity;&#xD;
Was a congenital anomaly/birth defect;&#xD;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period</measure>
    <time_frame>16 weeks</time_frame>
    <description>Marked laboratory abnormalities are defined for each parameter below.&#xD;
ULN = upper limit of normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Pressure During the Placebo-controlled Period</measure>
    <time_frame>Baseline, week 2, week 4, and week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pulse Rate During the Placebo-controlled Period</measure>
    <time_frame>Baseline and week 2, week 4, and week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight During the Placebo-controlled Period</measure>
    <time_frame>Baseline and week 2, week 4, and week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Waist Circumference During the Placebo-controlled Period</measure>
    <time_frame>Baseline and week 2, week 4, and week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in DLQI at Weeks 32 and 52</measure>
    <time_frame>Baseline, week 32 and week 52</time_frame>
    <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DLQI at Weeks 32 and 52</measure>
    <time_frame>Baseline, week 32 and week 52</time_frame>
    <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Itch NRS Score at Weeks 32 and 52</measure>
    <time_frame>Baseline, week 32 and week 52</time_frame>
    <description>The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.&#xD;
A negative change from baseline indicates improvement in itch severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52</measure>
    <time_frame>Baseline, week 32 and week 52</time_frame>
    <description>Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.&#xD;
A negative change from baseline indicates improvement in skin discomfort/pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 52</measure>
    <time_frame>Baseline, week 32 and week 52</time_frame>
    <description>Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot;), which equates to approximately 1% of total BSA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52</measure>
    <time_frame>Week 32 and week 52</time_frame>
    <description>The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (32 weeks and 52 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PASI Score &lt; 3 at Weeks 32 and 52</measure>
    <time_frame>Week 32 and week 52</time_frame>
    <description>The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in EQ-5D VAS Score at Week 52</measure>
    <time_frame>Baseline and week 52</time_frame>
    <description>EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in EQ-5D Index Score at Week 52</measure>
    <time_frame>Baseline and week 52</time_frame>
    <description>EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.&#xD;
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed</measure>
    <time_frame>Baseline and week 52</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment</measure>
    <time_frame>Baseline and week 52</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment</measure>
    <time_frame>Baseline and week 52</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment</measure>
    <time_frame>Baseline and week 52</time_frame>
    <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs During Apremilast Treatment</measure>
    <time_frame>From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.</time_frame>
    <description>An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.&#xD;
A serious adverse event (SAE) is any AE occurring at any dose that:&#xD;
Resulted in death;&#xD;
Was life-threatening;&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization;&#xD;
Resulted in persistent or significant disability/incapacity;&#xD;
Was a congenital anomaly/birth defect;&#xD;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment</measure>
    <time_frame>From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Pressure at End of Apremilast Extension Period</measure>
    <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pulse Rate at End of Apremilast Extension Period</measure>
    <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Weight at End of Apremilast Extension Period</measure>
    <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Waist Circumference at End of Apremilast Extension Period</measure>
    <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">277</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Apremilast 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo / Apremilast 30 mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take placebo tablets orally twice a day for 16 weeks. After week 16, participants will be switched to receive apremilast 30 mg twice daily until Week 52.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apremilast</intervention_name>
    <description>Apremilast 30 mg tablets taken orally twice a day.</description>
    <arm_group_label>Apremilast 30 mg</arm_group_label>
    <arm_group_label>Placebo / Apremilast 30 mg</arm_group_label>
    <other_name>Otezla</other_name>
    <other_name>CC-10004</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets taken orally twice a day</description>
    <arm_group_label>Placebo / Apremilast 30 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must satisfy the following criteria to be enrolled in the study:&#xD;
&#xD;
          1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).&#xD;
&#xD;
          2. Subject must understand and voluntarily sign an ICF prior to any study-related&#xD;
             assessments/procedures being conducted.&#xD;
&#xD;
          3. Subject is willing and able to adhere to the study visit schedule and other protocol&#xD;
             requirements.&#xD;
&#xD;
          4. Subject has diagnosis of chronic plaque psoriasis for at least 6 months prior to&#xD;
             baseline, that cannot be controlled by topical therapy.&#xD;
&#xD;
          5. Subject has a PASI score ranging from ≥ 3 to ≤ 10 at baseline.&#xD;
&#xD;
          6. Subject has a DLQI score &gt; 10 at baseline.&#xD;
&#xD;
          7. Subject has presence of ≥ 1 clinical manifestations of plaque psoriasis, defined as at&#xD;
             least one of the following:&#xD;
&#xD;
               1. Moderate to severe scalp psoriasis, defined as Scalp Physician Global Assessment&#xD;
                  (ScPGA) ≥ 3&#xD;
&#xD;
               2. Nail psoriasis, defined as onycholysis and onychodystrophy in at least 2&#xD;
                  fingernails&#xD;
&#xD;
               3. Moderate to severe genital plaque psoriasis, defined as modified static&#xD;
                  Physicians Global Assessment of Genitalia (sPGA-G) ≥ 3&#xD;
&#xD;
               4. Moderate to severe palmoplantar psoriasis, defined as Palmoplantar Psoriasis&#xD;
                  Physicians Global Assessment (PPPGA) ≥ 3&#xD;
&#xD;
               5. Moderate to severe plaque psoriasis in visible locations (dorsal hand, face,&#xD;
                  neck, and hairline) with static Physicians Global Assessment (sPGA) ≥ 3&#xD;
&#xD;
          8. Subject must be in general good health (except for psoriasis) as judged by the&#xD;
             Investigator, based on medical history, physical examination, and clinical&#xD;
             laboratories.&#xD;
&#xD;
             (NOTE: The definition of good health means a subject does not have uncontrolled&#xD;
             significant co-morbid conditions.)&#xD;
&#xD;
          9. Subject must have failed to respond to, or be contraindicated to, or intolerant to&#xD;
             other systemic therapy, including, but not limited to, cyclosporine, methotrexate,&#xD;
             acitretin, psoralen and ultraviolet-A-light (PUVA) fumaric acid esters or biologic&#xD;
             therapies.&#xD;
&#xD;
         10. Subjects (in Italy only) must be non-responder to, contraindicated to, or intolerant&#xD;
             to other systemic therapy (including cyclosporine, methotrexate, or PUVA) AND also be&#xD;
             contraindicated to, or intolerant to biologics.&#xD;
&#xD;
         11. Females of childbearing potential (FCBP) must have a negative pregnancy test at&#xD;
             Screening and Baseline. While on investigational product and for at least 28 days&#xD;
             after taking the last dose of investigational product, FCBP who engage in activity in&#xD;
             which conception is possible must use one of the approved contraceptive options&#xD;
             described below:&#xD;
&#xD;
        Option 1: Any one of the following highly effective methods: hormonal contraception (oral,&#xD;
        injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal&#xD;
        ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or&#xD;
        nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS&#xD;
        one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with&#xD;
        spermicide; or (c) contraceptive sponge with spermicide.&#xD;
&#xD;
        NOTE: Option 2 may not be acceptable as a highly effective contraception option in all&#xD;
        countries per local guidelines/regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The presence of any of the following will exclude a subject from enrollment:&#xD;
&#xD;
          1. Subject has any condition, including other inflammatory diseases or dermatologic&#xD;
             conditions, which confounds the ability to interpret data from the study, including&#xD;
             other types of psoriasis (ie, erythrodermic, or guttate), other than plaque psoriasis&#xD;
             or inverse psoriasis.&#xD;
&#xD;
          2. Subject has history of drug-induced psoriasis.&#xD;
&#xD;
          3. Subject has arthritis that requires systemic treatment.&#xD;
&#xD;
          4. Subject unable to avoid use of tanning booths for at least 4 weeks prior to baseline&#xD;
             and during study.&#xD;
&#xD;
          5. Subject is currently enrolled in any other clinical trial involving an investigational&#xD;
             product.&#xD;
&#xD;
          6. Other than psoriasis, subject has history of clinically significant or uncontrolled&#xD;
             disease (as determined by the Investigator), including the presence of laboratory&#xD;
             abnormalities, cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,&#xD;
             renal, hematologic, immunologic disease, or other major disease, which places the&#xD;
             subject at unacceptable risk if he/she were to participate in the study&#xD;
&#xD;
          7. Prior history of suicide attempt at any time in the subject's lifetime prior to&#xD;
             signing the informed consent, or major psychiatric illness requiring hospitalization&#xD;
             within the last 3 years prior to signing the informed consent.&#xD;
&#xD;
          8. Subjects with severe renal impairment, defined by estimated glomerular filtration rate&#xD;
             (eGFR) or creatinine clearance (CLcr) less than 30 mL/min, are also categorized as&#xD;
             having Stage 4 chronic kidney disease (CKD), and are excluded from the study.&#xD;
&#xD;
          9. Malignancy or history of malignancy or myeloproliferative or lymphoproliferative&#xD;
             disease within the past 3 years, except for treated (ie, cured) basal cell or squamous&#xD;
             cell in situ skin carcinomas.&#xD;
&#xD;
         10. Bacterial infections requiring treatment with oral or injectable antibiotics, or&#xD;
             significant viral or fungal infections, within 4 weeks of Screening. Any treatment for&#xD;
             such infections must have been completed and the infection cured, at least 4 weeks&#xD;
             prior to Screening and no new or recurrent infections prior to the Baseline Visit.&#xD;
&#xD;
         11. Subject has received a live vaccine within 3 months of baseline or plans to do so&#xD;
             during study.&#xD;
&#xD;
         12. Subject is a pregnant or breastfeeding (lactating) woman.&#xD;
&#xD;
         13. Subject has used topical therapy within 2 weeks of randomization (including, but not&#xD;
             limited to, topical corticosteroids, retinoids or vitamin D analog preparations,&#xD;
             tacrolimus, pimecrolimus, anthralin/dithranol, or moisturizers which contain urea or&#xD;
             salicylic acid). Use of phototherapy within 4 weeks prior to randomization. Use of&#xD;
             conventional systemic therapy or systemic corticosteroids within 4 weeks prior to&#xD;
             randomization, except for conditions other than psoriasis or psoriatic arthritis. Use&#xD;
             of biologic therapy within 5 pharmacokinetic half-lives.&#xD;
&#xD;
         14. Prior treatment with apremilast, or participation in a clinical study, involving&#xD;
             apremilast.&#xD;
&#xD;
         15. Subject has any condition that confounds the ability to interpret data from the study.&#xD;
&#xD;
         16. Subject has history of allergy or hypersensitivity to any components of the IP&#xD;
             (including placebo).&#xD;
&#xD;
         17. Subject has rare hereditary problem of galactose intolerance, lapp lactase deficiency&#xD;
             or glucose-galactose malabsorption.&#xD;
&#xD;
         18. Subject's most severe manifestation corresponds to a manifestation whose randomization&#xD;
             block has already been fully enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lyon Cedex 03</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris Cedex 10</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rouen Cedex</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Priest en Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valence</city>
        <zip>26953</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valenciennes</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Augsburg</city>
        <zip>86179</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10247</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>13086</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>13507</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bochum</city>
        <zip>44803</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bonn</city>
        <zip>53111</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gera</city>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Heidelberg</city>
        <zip>69115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jena</city>
        <zip>07743</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Langenau</city>
        <zip>89129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>München</city>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Napoli, Campania</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Napoli</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Perugia</city>
        <zip>06129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roma</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Badalona</city>
        <state>Cataluña</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alicante</city>
        <state>Comunidad Valenciana</state>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manises</city>
        <state>Comunidad Valenciana</state>
        <zip>46940</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fuenlabrada</city>
        <state>Madrid</state>
        <zip>28942</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Castellon de la Plana</city>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lugo</city>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barnet</city>
        <zip>EN5 3DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brighton</city>
        <zip>BN2 3EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bury Saint Edmunds</city>
        <zip>IP33 2QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dumfries</city>
        <zip>DG1 4AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gloucester</city>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Isleworth</city>
        <zip>TW7 6AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leeds</city>
        <zip>LS7 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newport</city>
        <zip>NP18 3XQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Redhill</city>
        <zip>RH1 5RH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stourbridge</city>
        <zip>DY8 4JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <reference>
    <citation>Mrowietz U, Barker J, Conrad C, Jullien D, Gisondi P, Flower A, Reddy J, Paris M, Picard H, Jardon S, Augustin M. Efficacy and safety of apremilast in patients with limited skin involvement, plaque psoriasis in special areas and impaired quality of life: Results from the EMBRACE randomized trial. J Eur Acad Dermatol Venereol. 2023 Feb;37(2):348-355. doi: 10.1111/jdv.18689. Epub 2022 Nov 14.</citation>
    <PMID>36300769</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <results_first_submitted>December 14, 2021</results_first_submitted>
  <results_first_submitted_qc>December 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2022</results_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Apremilast</keyword>
  <keyword>CC-10004</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Psoriasis manifestations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apremilast</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>http://www.amgen.com/datasharing</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03774875/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03774875/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible participants were enrolled at 55 centers in France, Germany, Italy, Spain, Switzerland, and the United Kingdom.&#xD;
The study consisted of a 16-week placebo-controlled period and a 36-week apremilast extension period.</recruitment_details>
      <pre_assignment_details>Participants were randomized in a 1:2 ratio to receive placebo or apremilast. Participants were block-randomized to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo / Apremilast 30 mg</title>
          <description>Participants received placebo tablets orally twice a day for 16 weeks. At Week 16 participants switched to receive 30 mg apremilast orally twice a day up to week 52.</description>
        </group>
        <group group_id="P2">
          <title>Apremilast 30 mg</title>
          <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Placebo-controlled Period (Week 1-16)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="185"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="185"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Unknown</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Apremilast Extension Period (Week 16-52)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo / Apremilast 30 mg</title>
          <description>Participants received placebo tablets orally twice a day for 16 weeks. At Week 16 participants switched to receive 30 mg apremilast orally twice a day up to week 52.</description>
        </group>
        <group group_id="B2">
          <title>Apremilast 30 mg</title>
          <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="92"/>
            <count group_id="B2" value="185"/>
            <count group_id="B3" value="277"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.9" spread="13.68"/>
                    <measurement group_id="B2" value="47.4" spread="14.28"/>
                    <measurement group_id="B3" value="48.6" spread="14.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="231"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="179"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Collected or Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Switzerland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Plaque Psoriasis</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.41" spread="13.350"/>
                    <measurement group_id="B2" value="16.31" spread="13.116"/>
                    <measurement group_id="B3" value="17.01" spread="13.207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Manifestations for Stratifications</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Scalp Psoriasis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nail Psoriasis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Palmoplantar Psoriasis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Genital Psoriasis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Psoriasis in Visible Locations</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dermatology Life Quality Index (DLQI) Score</title>
          <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.5" spread="4.94"/>
                    <measurement group_id="B2" value="18.1" spread="4.86"/>
                    <measurement group_id="B3" value="18.2" spread="4.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16</title>
        <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16</title>
          <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.</description>
          <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" lower_limit="30.0" upper_limit="52.6"/>
                    <measurement group_id="O2" value="73.3" lower_limit="66.7" upper_limit="79.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>The CMH (Cochran-Mantel-Haenszel) test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.</method_desc>
            <param_type>Adjusted Difference in Response Rates</param_type>
            <param_value>31.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.6</ci_lower_limit>
            <ci_upper_limit>45.2</ci_upper_limit>
            <estimate_desc>Adjusted difference (apremilast - placebo) in response rates calculated using the weighted average of the treatment differences across the strata with the CMH weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DLQI at Week 16</title>
        <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DLQI at Week 16</title>
          <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.</description>
          <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="0.80"/>
                    <measurement group_id="O2" value="-8.7" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and baseline value as a covariate.</method_desc>
            <param_type>Least Squares (LS) Mean Difference</param_type>
            <param_value>-5.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.95</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.15</ci_lower_limit>
            <ci_upper_limit>-3.43</ci_upper_limit>
            <estimate_desc>Difference in LS Means = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16</title>
        <description>Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot;), which equates to approximately 1% of total BSA.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16</title>
          <description>Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot;), which equates to approximately 1% of total BSA.</description>
          <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" spread="12.95"/>
                    <measurement group_id="O2" value="-19.8" spread="6.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0085</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate variable.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-38.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>14.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-66.58</ci_lower_limit>
            <ci_upper_limit>-10.14</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16</title>
        <description>The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.&#xD;
A negative change from baseline indicates improvement in itch severity.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16</title>
          <description>The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.&#xD;
A negative change from baseline indicates improvement in itch severity.</description>
          <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.32"/>
                    <measurement group_id="O2" value="-2.5" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.34</ci_lower_limit>
            <ci_upper_limit>-0.86</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16</title>
        <description>Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.&#xD;
A negative change from baseline indicates improvement in skin discomfort/pain.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16</title>
          <description>Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.&#xD;
A negative change from baseline indicates improvement in skin discomfort/pain.</description>
          <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.4" spread="3.61"/>
                    <measurement group_id="O2" value="-21.5" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-16.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.63</ci_lower_limit>
            <ci_upper_limit>-7.60</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score &lt; 3 at Week 16</title>
        <description>The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.</description>
        <time_frame>Week 16</time_frame>
        <population>All randomized participants; missing data at week 16 were imputed using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score &lt; 3 at Week 16</title>
          <description>The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.</description>
          <population>All randomized participants; missing data at week 16 were imputed using multiple imputation.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.3" lower_limit="16.6" upper_limit="36.0"/>
                    <measurement group_id="O2" value="39.7" lower_limit="32.3" upper_limit="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0328</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test adjusted for the stratification of the 5 difficult to treat manifestation types at randomization.</method_desc>
            <param_type>Adjusted Difference in Response Rates</param_type>
            <param_value>13.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>25.8</ci_upper_limit>
            <estimate_desc>The adjusted difference in response rates (Apremilast - Placebo) using the weighted average of the treatment differences across the strata with the CMH weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16</title>
        <description>The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (16 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).</description>
        <time_frame>Week 16</time_frame>
        <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16</title>
          <description>The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (16 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).</description>
          <population>All randomized participants; Missing data at week 16 were imputed using multiple imputation.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9" lower_limit="28.8" upper_limit="51.0"/>
                    <measurement group_id="O2" value="76.6" lower_limit="70.2" upper_limit="83.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>Cochran-Mantel-Haenszel test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.</method_desc>
            <param_type>Adjusted Difference in Response Rates</param_type>
            <param_value>37.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.58</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.1</ci_lower_limit>
            <ci_upper_limit>49.9</ci_upper_limit>
            <estimate_desc>Adjusted difference (Apremilast - Placebo) in response rates using the weighted average of the treatment differences across the strata with the CMH weights.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16</title>
        <description>EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants with available data at baseline and week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16</title>
          <description>EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.</description>
          <population>All randomized participants with available data at baseline and week 16.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" spread="15.96"/>
                    <measurement group_id="O2" value="33.8" spread="10.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4216</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>14.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>18.55</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.62</ci_lower_limit>
            <ci_upper_limit>51.48</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in EQ-5D Index Score at Week 16</title>
        <description>EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.&#xD;
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants with available data at baseline and week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in EQ-5D Index Score at Week 16</title>
          <description>EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.&#xD;
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.</description>
          <population>All randomized participants with available data at baseline and week 16.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165.9" spread="89.80"/>
                    <measurement group_id="O2" value="17.8" spread="59.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1559</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-148.024</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>103.9525</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-352.8793</ci_lower_limit>
            <ci_upper_limit>56.8304</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants with available data and who had reported being employed at baseline and at week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.</description>
          <population>All randomized participants with available data and who had reported being employed at baseline and at week 16.</population>
          <units>percent impairment</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="2.56"/>
                    <measurement group_id="O2" value="-0.9" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2667</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>3.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.82</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.43</ci_lower_limit>
            <ci_upper_limit>8.73</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants with available data and who had reported being employed at baseline and at week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
          <population>All randomized participants with available data and who had reported being employed at baseline and at week 16.</population>
          <units>percent impairment</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.5" spread="3.82"/>
                    <measurement group_id="O2" value="-13.9" spread="2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5620</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.83</ci_lower_limit>
            <ci_upper_limit>5.91</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants with available data and who had reported being employed at baseline and at week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
          <population>All randomized participants with available data and who had reported being employed at baseline and at week 16.</population>
          <units>percent impairment</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.2" spread="4.35"/>
                    <measurement group_id="O2" value="-13.8" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8927</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.81</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.16</ci_lower_limit>
            <ci_upper_limit>8.86</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 16</time_frame>
        <population>All randomized participants with available data at baseline and at week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
          <population>All randomized participants with available data at baseline and at week 16.</population>
          <units>percent impairment</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.4" spread="3.66"/>
                    <measurement group_id="O2" value="-21.2" spread="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0572</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.</method_desc>
            <param_type>LS Mean Difference</param_type>
            <param_value>-7.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.90</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
            <estimate_desc>LS Mean Difference = Apremilast - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period</title>
        <description>An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.&#xD;
A serious adverse event (SAE) is any AE occurring at any dose that:&#xD;
Resulted in death;&#xD;
Was life-threatening;&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization;&#xD;
Resulted in persistent or significant disability/incapacity;&#xD;
Was a congenital anomaly/birth defect;&#xD;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.</description>
        <time_frame>From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period.</time_frame>
        <population>All randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period</title>
          <description>An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.&#xD;
A serious adverse event (SAE) is any AE occurring at any dose that:&#xD;
Resulted in death;&#xD;
Was life-threatening;&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization;&#xD;
Resulted in persistent or significant disability/incapacity;&#xD;
Was a congenital anomaly/birth defect;&#xD;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.</description>
          <population>All randomized participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to drug interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to drug withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period</title>
        <description>Marked laboratory abnormalities are defined for each parameter below.&#xD;
ULN = upper limit of normal</description>
        <time_frame>16 weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug with at least one post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period</title>
          <description>Marked laboratory abnormalities are defined for each parameter below.&#xD;
ULN = upper limit of normal</description>
          <population>All randomized participants who received at least one dose of study drug with at least one post-baseline measurement.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alanine Aminotransferase &gt; 3 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin &lt; 25 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase &gt; 400 U/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase &gt; 3 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin (umol/L) &gt; 1.8 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen &gt; 15 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium &lt; 1.8 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium &gt; 3.0 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol &gt; 7.8 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine &gt; 1.7 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose &lt; 2.8 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose &gt; 13.9 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin A1C (Fasting) &gt; 9%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lactate Dehydrogenase &gt; 3 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium &lt; 3.0 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium &gt; 5.5 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium &lt; 130 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium &gt; 150 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides &gt; 3.4 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: Female &lt; 85 g/L, Male &lt; 105 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: Female &gt; 170 g/L, Male &gt; 185 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes &lt; 1.5 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes &lt; 0.8 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Segmented &lt; 1.0 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &lt; 75 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &gt; 600 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Pressure During the Placebo-controlled Period</title>
        <time_frame>Baseline, week 2, week 4, and week 16</time_frame>
        <population>Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Pressure During the Placebo-controlled Period</title>
          <population>Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic: week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="11.17"/>
                    <measurement group_id="O2" value="0.1" spread="12.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic: week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="12.29"/>
                    <measurement group_id="O2" value="0.4" spread="11.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic: week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="13.77"/>
                    <measurement group_id="O2" value="1.0" spread="12.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic: week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="7.89"/>
                    <measurement group_id="O2" value="-0.6" spread="8.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic: week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="7.62"/>
                    <measurement group_id="O2" value="-1.0" spread="9.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic: week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="8.29"/>
                    <measurement group_id="O2" value="0.6" spread="9.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pulse Rate During the Placebo-controlled Period</title>
        <time_frame>Baseline and week 2, week 4, and week 16</time_frame>
        <population>Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate During the Placebo-controlled Period</title>
          <population>Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.</population>
          <units>beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="10.82"/>
                    <measurement group_id="O2" value="3.4" spread="9.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="10.17"/>
                    <measurement group_id="O2" value="3.5" spread="10.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="9.97"/>
                    <measurement group_id="O2" value="2.0" spread="10.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight During the Placebo-controlled Period</title>
        <time_frame>Baseline and week 2, week 4, and week 16</time_frame>
        <population>Randomized participants who received at least one dose of study drug and with with a baseline value and a post-baseline value at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight During the Placebo-controlled Period</title>
          <population>Randomized participants who received at least one dose of study drug and with with a baseline value and a post-baseline value at each time point.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="1.161"/>
                    <measurement group_id="O2" value="-0.31" spread="1.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="1.285"/>
                    <measurement group_id="O2" value="-0.57" spread="2.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="153"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="2.337"/>
                    <measurement group_id="O2" value="-0.98" spread="2.722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Waist Circumference During the Placebo-controlled Period</title>
        <time_frame>Baseline and week 2, week 4, and week 16</time_frame>
        <population>Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Waist Circumference During the Placebo-controlled Period</title>
          <population>Randomized participants who received at least one dose of study drug and with a baseline value and a post-baseline value at each time point.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="3.93"/>
                    <measurement group_id="O2" value="0.2" spread="3.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="4.89"/>
                    <measurement group_id="O2" value="-0.3" spread="3.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="6.16"/>
                    <measurement group_id="O2" value="-0.9" spread="5.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in DLQI at Weeks 32 and 52</title>
        <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.</description>
        <time_frame>Baseline, week 32 and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received 30 mg apremilast tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in DLQI at Weeks 32 and 52</title>
          <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.</description>
          <population>Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.1" lower_limit="55.8" upper_limit="78.8"/>
                    <measurement group_id="O2" value="68.4" lower_limit="60.4" upper_limit="75.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.8" lower_limit="65.1" upper_limit="86.1"/>
                    <measurement group_id="O2" value="79.6" lower_limit="72.3" upper_limit="85.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in DLQI at Weeks 32 and 52</title>
        <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.</description>
        <time_frame>Baseline, week 32 and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in DLQI at Weeks 32 and 52</title>
          <description>The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.8" spread="8.19"/>
                    <measurement group_id="O2" value="-9.9" spread="7.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.3" spread="7.84"/>
                    <measurement group_id="O2" value="-11.2" spread="7.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Itch NRS Score at Weeks 32 and 52</title>
        <description>The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.&#xD;
A negative change from baseline indicates improvement in itch severity.</description>
        <time_frame>Baseline, week 32 and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Itch NRS Score at Weeks 32 and 52</title>
          <description>The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.&#xD;
A negative change from baseline indicates improvement in itch severity.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.2" spread="3.50"/>
                    <measurement group_id="O2" value="-2.8" spread="3.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                    <count group_id="O2" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="3.61"/>
                    <measurement group_id="O2" value="-3.3" spread="3.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52</title>
        <description>Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.&#xD;
A negative change from baseline indicates improvement in skin discomfort/pain.</description>
        <time_frame>Baseline, week 32 and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52</title>
          <description>Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.&#xD;
A negative change from baseline indicates improvement in skin discomfort/pain.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.4" spread="38.40"/>
                    <measurement group_id="O2" value="-22.6" spread="33.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.0" spread="36.76"/>
                    <measurement group_id="O2" value="-31.0" spread="34.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 52</title>
        <description>Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot;), which equates to approximately 1% of total BSA.</description>
        <time_frame>Baseline, week 32 and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 52</title>
          <description>Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or &quot;handprint&quot;), which equates to approximately 1% of total BSA.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data at baseline and each time point</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.5" spread="47.35"/>
                    <measurement group_id="O2" value="-40.2" spread="51.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.9" spread="53.25"/>
                    <measurement group_id="O2" value="-32.0" spread="93.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52</title>
        <description>The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (32 weeks and 52 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).</description>
        <time_frame>Week 32 and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52</title>
          <description>The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (32 weeks and 52 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).</description>
          <population>Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="54.3" upper_limit="77.6"/>
                    <measurement group_id="O2" value="67.8" lower_limit="59.7" upper_limit="75.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" lower_limit="52.8" upper_limit="76.3"/>
                    <measurement group_id="O2" value="63.8" lower_limit="55.6" upper_limit="71.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PASI Score &lt; 3 at Weeks 32 and 52</title>
        <description>The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.</description>
        <time_frame>Week 32 and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PASI Score &lt; 3 at Weeks 32 and 52</title>
          <description>The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.</description>
          <population>Randomized participants who entered the apremilast extension phase. Missing data were imputed using non-responder imputation.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 32</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.0" lower_limit="45.5" upper_limit="69.8"/>
                    <measurement group_id="O2" value="40.1" lower_limit="32.3" upper_limit="48.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.7" lower_limit="38.4" upper_limit="63.0"/>
                    <measurement group_id="O2" value="37.5" lower_limit="29.8" upper_limit="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in EQ-5D VAS Score at Week 52</title>
        <description>EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data at baseline and week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in EQ-5D VAS Score at Week 52</title>
          <description>EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data at baseline and week 52</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4" spread="132.13"/>
                    <measurement group_id="O2" value="33.6" spread="78.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in EQ-5D Index Score at Week 52</title>
        <description>EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.&#xD;
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data at baseline and week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in EQ-5D Index Score at Week 52</title>
          <description>EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.&#xD;
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data at baseline and week 52</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214.103" spread="1799.6328"/>
                    <measurement group_id="O2" value="11.039" spread="224.3001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.</population>
          <units>percent impairment</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.6" spread="17.43"/>
                    <measurement group_id="O2" value="-3.2" spread="17.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.</population>
          <units>percent impairment</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.0" spread="29.82"/>
                    <measurement group_id="O2" value="-24.4" spread="26.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data and who had reported being employed at baseline and at week 52.</population>
          <units>percent impairment</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.7" spread="30.12"/>
                    <measurement group_id="O2" value="-25.3" spread="29.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment</title>
        <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
        <time_frame>Baseline and week 52</time_frame>
        <population>Randomized participants who entered the apremilast extension phase with available data at baseline and week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo / Apremilast 30 mg</title>
            <description>Participants received placebo tablets orally twice a day for 16 weeks followed by 30 mg apremilast orally twice a day from week 16 to week 52.</description>
          </group>
          <group group_id="O2">
            <title>Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg tablets orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment</title>
          <description>The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.</description>
          <population>Randomized participants who entered the apremilast extension phase with available data at baseline and week 52</population>
          <units>percent impairment</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.7" spread="33.94"/>
                    <measurement group_id="O2" value="-30.5" spread="27.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs During Apremilast Treatment</title>
        <description>An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.&#xD;
A serious adverse event (SAE) is any AE occurring at any dose that:&#xD;
Resulted in death;&#xD;
Was life-threatening;&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization;&#xD;
Resulted in persistent or significant disability/incapacity;&#xD;
Was a congenital anomaly/birth defect;&#xD;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.</description>
        <time_frame>From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.</time_frame>
        <population>All randomized participants who received at least one dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase and received at least one dose of apremilast.</population>
        <group_list>
          <group group_id="O1">
            <title>Apremilast 30 mg</title>
            <description>Participants initially randomized to placebo received apremilast 30 mg orally twice a day from week 16 to week 52. Participants initially randomized to apremilast received apremilast 30 mg orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs During Apremilast Treatment</title>
          <description>An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.&#xD;
A serious adverse event (SAE) is any AE occurring at any dose that:&#xD;
Resulted in death;&#xD;
Was life-threatening;&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization;&#xD;
Resulted in persistent or significant disability/incapacity;&#xD;
Was a congenital anomaly/birth defect;&#xD;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.</description>
          <population>All randomized participants who received at least one dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase and received at least one dose of apremilast.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="254"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to drug interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to drug withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment</title>
        <time_frame>From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.</time_frame>
        <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, and with at least 1 post-baseline measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Apremilast 30 mg</title>
            <description>Participants initially randomized to placebo received apremilast 30 mg orally twice a day from week 16 to week 52. Participants initially randomized to apremilast received apremilast 30 mg orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment</title>
          <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, and with at least 1 post-baseline measurement.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="235"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Alanine Aminotransferase &gt; 3 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin &lt; 25 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase &gt; 400 U/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase &gt; 3 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin &gt; 1.8 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen &gt; 15 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium &lt; 1.8 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium &gt; 3.0 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol &gt; 7.8 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine &gt; 1.7 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose &lt; 2.8 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose &gt; 13.9 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin A1C (Fasting) &gt; 9%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lactate Dehydrogenase &gt; 3 × ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="228"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium &lt; 3.0 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium &gt; 5.5 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium &lt; 130 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium &gt; 150 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides &gt; 3.4 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="235"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: Female &lt; 85 g/L, Male &lt; 105 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin: Female &gt; 170 g/L, Male &gt; 185 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes &lt; 1.5 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes &lt; 0.8 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Segmented &lt; 1.0 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &lt; 75 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &gt; 600 × 10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Pressure at End of Apremilast Extension Period</title>
        <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
        <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase, with a baseline value and at least 1 post-baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>Apremilast 30 mg</title>
            <description>Participants initially randomized to placebo received apremilast 30 mg orally twice a day from week 16 to week 52. Participants initially randomized to apremilast received apremilast 30 mg orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Pressure at End of Apremilast Extension Period</title>
          <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase, with a baseline value and at least 1 post-baseline value.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="13.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="8.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pulse Rate at End of Apremilast Extension Period</title>
        <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
        <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>Apremilast 30 mg</title>
            <description>Participants initially randomized to placebo received apremilast 30 mg orally twice a day from week 16 to week 52. Participants initially randomized to apremilast received apremilast 30 mg orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate at End of Apremilast Extension Period</title>
          <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.</population>
          <units>beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="10.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight at End of Apremilast Extension Period</title>
        <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
        <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.</population>
        <group_list>
          <group group_id="O1">
            <title>Apremilast 30 mg</title>
            <description>Participants initially randomized to placebo received apremilast 30 mg orally twice a day from week 16 to week 52. Participants initially randomized to apremilast received apremilast 30 mg orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight at End of Apremilast Extension Period</title>
          <population>Randomized participants who received at least 1 dose of apremilast, ie, participants originally randomized to apremilast and participants originally randomized to placebo who entered the apremilast extension phase with at least 1 treatment of apremilast, with a baseline value and at least 1 post-baseline value.</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.20" spread="3.802"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Waist Circumference at End of Apremilast Extension Period</title>
        <time_frame>Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</time_frame>
        <population>Baseline and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</population>
        <group_list>
          <group group_id="O1">
            <title>Apremilast 30 mg</title>
            <description>Participants initially randomized to placebo received apremilast 30 mg orally twice a day from week 16 to week 52. Participants initially randomized to apremilast received apremilast 30 mg orally twice a day for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Waist Circumference at End of Apremilast Extension Period</title>
          <population>Baseline and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Placebo-controlled period: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period. Apremilast extension period: From first dose of apremilast in the extension period to 28 days after last dose, up to 40 weeks.</time_frame>
      <desc>All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo-controlled Period: Placebo</title>
          <description>Participants received placebo tablets orally twice a day for 16 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Placebo-controlled Period: Apremilast 30 mg</title>
          <description>Participants received apremilast 30 mg tablets orally twice a day for 16 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Apremilast Extension Period: Apremilast 30 mg</title>
          <description>Participants received apremilast 30 mg tablets orally twice a day from week 16 to week 52 (36 weeks).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Erythema migrans</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Prolactin-producing pituitary tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="113" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="93" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="221"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="185"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="221"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
      <email>medinfo@amgen.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774875
org study id: CC-10004-PSOR-020
secondary id: U1111-1224-8381
secondary id: 2018-002850-58
nct id: NCT03774875
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to assess the impact of treatment with apremilast 30 mg
      twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in
      adults with manifestations of plaque psoriasis and impaired quality of life.
Participants will be randomized 2 (apremilast):1 (placebo) in approximately 10 countries in
      Western Europe. Participants will be block-randomized to each of the manifestations of
      psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and
      psoriasis in visible locations). Participants presenting with multiple manifestations will be
      allocated to the manifestation which is most severe, as determined by the participant. All
      manifestations will be assessed for efficacy at each study visit.

      The study will consist of 4 phases:

        -  Screening Phase - up to 5 weeks (35 days)

        -  Double-blind Placebo-controlled Phase - Weeks 0 to 16 Participants will receive
           treatment with either apremilast or matched placebo.

        -  Apremilast Extension Phase - Weeks 16 through 52 All participants will be switched to
           (or continue with) apremilast at week 16 and will maintain this dosing through week 52.

        -  Post-treatment Observational Follow-up Phase 4-week post-treatment observational
           follow-up phase for all participants who complete the study on treatment or discontinue
           from the study treatment early.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
time frame: Baseline and week 16
description: The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.
measure: Change From Baseline in DLQI at Week 16
time frame: Baseline and week 16
description: The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.
measure: Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16
time frame: Baseline and week 16
description: Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.
measure: Change From Baseline in Itch Numeric Rating Scale (NRS) Score at Week 16
time frame: Baseline and week 16
description: The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.
A negative change from baseline indicates improvement in itch severity.
measure: Change From Baseline in Skin Discomfort/Pain Visual Analog Scale (VAS) at Week 16
time frame: Baseline and week 16
description: Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.
A negative change from baseline indicates improvement in skin discomfort/pain.
measure: Percentage of Participants Who Achieved a Psoriasis Area Severity Index (PASI) Score < 3 at Week 16
time frame: Week 16
description: The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
measure: Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Global Score of ≥ 1 at Week 16
time frame: Week 16
description: The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (16 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).
measure: Percent Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) VAS Score at Week 16
time frame: Baseline and week 16
description: EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.
measure: Percent Change From Baseline in EQ-5D Index Score at Week 16
time frame: Baseline and week 16
description: EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI: PSO) at Week 16: Percentage Work Time Missed
time frame: Baseline and week 16
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.
measure: Change From Baseline in WPAI: PSO at Week 16: Percentage Work Impairment
time frame: Baseline and week 16
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
measure: Change From Baseline in WPAI: PSO at Week 16: Percentage Overall Work Impairment
time frame: Baseline and week 16
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
measure: Change From Baseline in WPAI: PSO at Week 16: Percentage Activity Impairment
time frame: Baseline and week 16
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Placebo-controlled Period
time frame: From first dose of study drug to week 16 or up to 28 days after last dose for participants who didn't enter the apremilast extension period.
description: An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.
measure: Number of Participants With Marked Laboratory Abnormalities During the Placebo-controlled Period
time frame: 16 weeks
description: Marked laboratory abnormalities are defined for each parameter below.
ULN = upper limit of normal
measure: Change From Baseline in Blood Pressure During the Placebo-controlled Period
time frame: Baseline, week 2, week 4, and week 16
measure: Change From Baseline in Pulse Rate During the Placebo-controlled Period
time frame: Baseline and week 2, week 4, and week 16
measure: Change From Baseline in Body Weight During the Placebo-controlled Period
time frame: Baseline and week 2, week 4, and week 16
measure: Change From Baseline in Waist Circumference During the Placebo-controlled Period
time frame: Baseline and week 2, week 4, and week 16
measure: Percentage of Participants Who Achieved a ≥ 4-point Reduction From Baseline in DLQI at Weeks 32 and 52
time frame: Baseline, week 32 and week 52
description: The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life (QOL). The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL.
measure: Change From Baseline in DLQI at Weeks 32 and 52
time frame: Baseline, week 32 and week 52
description: The DLQI is a 10-item skin disease-specific questionnaire used to evaluate the impact of skin disease on health-related quality of life. The items address symptoms and feelings, daily activities, leisure, work/school, personal relationships, and issues with treatment. Questions are answered on a 4-point scale from 0 (not at all/not applicable) to 3 (very much). Item scores are added to provide a total score from 0 to 30, with higher scores indicating greater impairment of QOL. A negative change from baseline indicates improvement in quality of life.
measure: Change From Baseline in Itch NRS Score at Weeks 32 and 52
time frame: Baseline, week 32 and week 52
description: The Itch Numeric Rating Scale (NRS) asked participants to assess the worst severity of itch experienced over the past 24 hours on an 11-point scale anchored from 0, representing 'no itching' to 10, representing 'worst itch imaginable'.
A negative change from baseline indicates improvement in itch severity.
measure: Change From Baseline in Skin Discomfort/Pain VAS at Weeks 32 and 52
time frame: Baseline, week 32 and week 52
description: Participants were asked to indicate their level of skin discomfort/pain in the past week by placing a vertical stroke on a 100 mm horizontal line on which the left-hand boundary (0) represents no skin discomfort/pain, and the right-hand boundary (100) represents worst possible skin discomfort/pain. The distance from the mark to the left-hand boundary was recorded.
A negative change from baseline indicates improvement in skin discomfort/pain.
measure: Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 32 and 52
time frame: Baseline, week 32 and week 52
description: Body surface area is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.
measure: Percentage of Participants Who Achieved a PBI Score of ≥ 1 at Weeks 32 and 52
time frame: Week 32 and week 52
description: The PBI is a validated patient-reported instrument to assess patient-relevant benefits of psoriasis treatment. Prior to starting study treatment, participants were asked to assess the importance of a series of treatment goals (from not important to very important) by completing the Patient Needs Questionnaire (PNQ). After a period of treatment (32 weeks and 52 weeks), participants were then asked to assess the extent to which these goals were achieved (from not at all to very) by completing the Patient Benefit Questionnaire (PBQ). The Patient Benefit Index represents the benefits realized as a function of most important needs. The PBI score ranges from 0 (no benefit) to 4 (maximum benefit).
measure: Percentage of Participants Who Achieved a PASI Score < 3 at Weeks 32 and 52
time frame: Week 32 and week 52
description: The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and the values for each anatomic region are summed to yield the PASI score. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
measure: Percent Change From Baseline in EQ-5D VAS Score at Week 52
time frame: Baseline and week 52
description: EQ-5D measures the participant's general health state on a vertical VAS and five quality of life domains. The EQ-5D VAS score ranges from 0 to 100, where a score of 0 indicates the worst imaginable health states and a score of 100 indicates the best imaginable health state. A positive change from baseline indicates improvement.
measure: Percent Change From Baseline in EQ-5D Index Score at Week 52
time frame: Baseline and week 52
description: EQ-5D measures the participants general health state as a vertical VAS and 5 quality of life domains: mobility, self-care, main activity (work, study, housework, family/leisure activities), pain/discomfort, and anxiety/depression. Each dimension is rated on three levels (no problems, some/moderate problems, extreme problems). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension.
EQ-5D index values were derived using the UK scoring algorithm, where a higher score indicates a better health state. The range of the score is from -0.224 to 1, with 0 corresponding to death, 1 corresponding to full health, and negative numbers indicate health states worse than death. A positive change from baseline indicates improvement.
measure: Change From Baseline in WPAI: PSO at Week 52: Percentage Work Time Missed
time frame: Baseline and week 52
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to psoriasis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed, and a negative change from baseline indicates improvement.
measure: Change From Baseline in WPAI: PSO at Week 52: Percentage Work Impairment
time frame: Baseline and week 52
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
measure: Change From Baseline in WPAI: PSO at Week 52: Percentage Overall Work Impairment
time frame: Baseline and week 52
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent overall work impairment takes into account both hours missed due to psoriasis symptoms and the participant's assessment of the degree to which psoriasis affected their productivity while working. A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
measure: Change From Baseline in WPAI: PSO at Week 52: Percentage Activity Impairment
time frame: Baseline and week 52
description: The WPAI: PSO is a self-administered questionnaire designed to address impairment to the work productivity and activity of participants due to psoriasis in the past 7 days. Percent activity impairment is derived from the patient's assessment of the degree to which psoriasis affected their regular daily unpaid activities, measured on a VAS from 1 (no effect on daily activities) to 10 (psoriasis completely prevented daily activities). A higher percentage indicates greater impairment and less productivity, and a negative change from baseline indicates improvement.
measure: Number of Participants With TEAEs During Apremilast Treatment
time frame: From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.
description: An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening of a preexisting condition was considered an AE.
A serious adverse event (SAE) is any AE occurring at any dose that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability/incapacity;
Was a congenital anomaly/birth defect;
Constituted an important medical event. The Investigator assessed the severity/intensity of each event as mild, moderate, or severe based on level of symptoms.
measure: Number of Participants With Marked Laboratory Abnormalities During Apremilast Treatment
time frame: From first dose of apremilast up to 28 days after last dose; up to 40 weeks for participants initially randomized to placebo and 56 weeks for participants initially randomized to apremilast.
measure: Change From Baseline in Blood Pressure at End of Apremilast Extension Period
time frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
measure: Change From Baseline in Pulse Rate at End of Apremilast Extension Period
time frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
measure: Change From Baseline in Body Weight at End of Apremilast Extension Period
time frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
measure: Change From Baseline in Waist Circumference at End of Apremilast Extension Period
time frame: Baseline (defined as the last value measured on or before the day of the first apremilast dose) and end of apremilast extension period; week 52, or earlier for participants who discontinued prior to week 52
arm group label: Apremilast 30 mg
arm group type: Experimental
description: Participants will take apremilast 30 mg tablets orally twice a day for up to 52 weeks.
arm group label: Placebo / Apremilast 30 mg
arm group type: Placebo Comparator
description: Participants will take placebo tablets orally twice a day for 16 weeks. After week 16, participants will be switched to receive apremilast 30 mg twice daily until Week 52.
intervention type: Drug
intervention name: Apremilast
description: Apremilast 30 mg tablets taken orally twice a day.
arm group label: Apremilast 30 mg
arm group label: Placebo / Apremilast 30 mg
other name: Otezla
other name: CC-10004
intervention type: Drug
intervention name: Placebo
description: Placebo tablets taken orally twice a day
arm group label: Placebo / Apremilast 30 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: France
country: Germany
country: Italy
country: Spain
country: Switzerland
country: United Kingdom
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: Mrowietz U, Barker J, Conrad C, Jullien D, Gisondi P, Flower A, Reddy J, Paris M, Picard H, Jardon S, Augustin M. Efficacy and safety of apremilast in patients with limited skin involvement, plaque psoriasis in special areas and impaired quality of life: Results from the EMBRACE randomized trial. J Eur Acad Dermatol Venereol. 2023 Feb;37(2):348-355. doi: 10.1111/jdv.18689. Epub 2022 Nov 14.
PMID: 36300769
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Apremilast
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: http://www.amgen.com/datasharing
provided document: 
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 