<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/NCT03777436</url>
  </required_header>
  <id_info>
    <org_study_id>CC-10004-PSOR-025</org_study_id>
    <secondary_id>U1111-1224-6850</secondary_id>
    <secondary_id>2018-002608-15</secondary_id>
    <nct_id>NCT03777436</nct_id>
  </id_info>
  <brief_title>An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis</brief_title>
  <acronym>DISCREET</acronym>
  <official_title>A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis</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>
      This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to&#xD;
      evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital&#xD;
      psoriasis (modified sPGA-G ≥3, moderate or severe).&#xD;
&#xD;
      Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1&#xD;
      to receive either apremilast 30 mg BID or placebo for the first 16 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of four phases:&#xD;
&#xD;
        -  Screening Phase - up to 35 days&#xD;
&#xD;
        -  Double-blind Placebo-controlled Phase - Weeks 0 to 16&#xD;
&#xD;
           - Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or&#xD;
           placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.&#xD;
&#xD;
        -  Apremilast Extension Phase - Weeks 16 to 32&#xD;
&#xD;
           - All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects&#xD;
           will maintain this dosing through Week 32.&#xD;
&#xD;
        -  Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational&#xD;
           Follow-up Phase for all subjects who complete the study or discontinue the study early.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Actual">February 9, 2022</completion_date>
  <primary_completion_date type="Actual">September 23, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</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 With a Modified sPGA-G Response at Week 16</measure>
    <time_frame>Baseline and Week 16 of the Placebo-controlled Phase</time_frame>
    <description>The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling.&#xD;
A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.&#xD;
Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16</measure>
    <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
    <description>The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.&#xD;
An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.&#xD;
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16</measure>
    <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
    <description>The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.&#xD;
A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline.&#xD;
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Affected Body Surface Area (BSA) at Week 16</measure>
    <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
    <description>The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or &quot;handprints&quot; (each entire palmar surface or &quot;handprint&quot; equates to approximately 1% of total BSA).&#xD;
A negative change from Baseline indicates a reduction of affected BSA.&#xD;
Based on mixed-effect model for repeated measures (MMRM) model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16</measure>
    <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
    <description>The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No), and if &quot;No,&quot; then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot).&#xD;
Total scores have a possible range of 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life.&#xD;
A negative change from Baseline indicates an improvement in health-related quality of life scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16</measure>
    <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
    <description>The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable.&#xD;
Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).&#xD;
A negative change from Baseline indicates an improvement in genital psoriasis symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">289</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Arm A- Apremilast with Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B - Apremilast 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive apremilast 30 mg tablets orally twice daily after the Week 16 Visit through the end of the Apremilast Extension Phase of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apremilast</intervention_name>
    <description>Oral</description>
    <arm_group_label>Arm A- Apremilast with Placebo</arm_group_label>
    <arm_group_label>Arm B - Apremilast 30 mg</arm_group_label>
    <other_name>CC-10004, Otezla</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral</description>
    <arm_group_label>Arm A- Apremilast with Placebo</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 have a diagnosis of chronic plaque psoriasis for at least 6 months prior&#xD;
             to signing the ICF.&#xD;
&#xD;
          3. Subject must have a diagnosis of moderate or severe psoriasis of the genital area at&#xD;
             Screening and Baseline.&#xD;
&#xD;
          4. Subject must have a diagnosis of moderate or severe psoriasis at Screening and&#xD;
             Baseline.&#xD;
&#xD;
          5. Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening&#xD;
             and Baseline.&#xD;
&#xD;
          6. Subject must have been inadequately controlled with or intolerant of topical therapy,&#xD;
             or topical therapy is inappropriate for the treatment of psoriasis affecting the&#xD;
             genital area.&#xD;
&#xD;
          7. Subject must be in good health (except for psoriasis) as judged by the investigator,&#xD;
             based on medical history, physical examination, clinical laboratories, and urinalysis.&#xD;
&#xD;
          8. Subject must meet laboratory criteria&#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 significant medical condition or laboratory abnormality, that would&#xD;
             prevent the subject from participating in the study.&#xD;
&#xD;
          2. Subject has any condition including the presence of laboratory abnormalities, which&#xD;
             places the subject at unacceptable risk if he/she were to participate in the study.&#xD;
&#xD;
          3. Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at&#xD;
             Screening.&#xD;
&#xD;
          4. Subject has active tuberculosis (TB) or a history of incompletely treated TB.&#xD;
&#xD;
          5. Subject has prior history of suicide attempt at any time in the subject's life time&#xD;
             prior to signing the informed consent and randomization, or major psychiatric illness&#xD;
             requiring hospitalization within the last 3 years prior to signing the informed&#xD;
             consent.&#xD;
&#xD;
          6. Subject has current or planned therapies that may have a possible effect on psoriasis&#xD;
             of the body and/or genital area during the course of the treatment phase of the trial&#xD;
&#xD;
          7. Subject had prior treatment with apremilast.&#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>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First OC Dermatology</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Science Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glick Skin Institute</name>
      <address>
        <city>Margate</city>
        <state>Florida</state>
        <zip>33073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Dermatology Research, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Care Physicians of Georgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dawes Fretzin Clinical Research Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adult and Pediatric Dermatology</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices and Research Inc</name>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Womens Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J Woodson Dermatology and Associates</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Dermatology</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook Dermatology Associates</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Consulting Services</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oakview Dermatology</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Gahanna</city>
        <state>Ohio</state>
        <zip>43230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paddington Testing Company Inc</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Partners LLC</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <zip>02919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research Inc</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellevue Dermatology Clinic</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Center for Skin Health</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Saint Pierre</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guenther Dermatology Research Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynderm Research Inc</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P1X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>K Papp Clinical Research</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dre Angelique Gagne-Henley M.D. Inc</name>
      <address>
        <city>Saint-Jerome</city>
        <state>Quebec</state>
        <zip>J7Z 7E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skincare Studio</name>
      <address>
        <city>St. John's</city>
        <zip>A1E 1V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Claude Huriez CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice Archet I</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Larrey University Hospital</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISA - Interdisciplinary Study Association GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hautklinik Universitatsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Schleswig-Holstein, Campus Luebeck</name>
      <address>
        <city>Luebeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55101</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti di Ancona</name>
      <address>
        <city>Ancona</city>
        <zip>60020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero della Misericordia</name>
      <address>
        <city>Grosseto</city>
        <zip>58100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore</name>
      <address>
        <city>LAquila</city>
        <zip>67100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Bianchi Melacrino Morelli</name>
      <address>
        <city>Reggio Calabria</city>
        <zip>89124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina</name>
      <address>
        <city>Terracina</city>
        <zip>04019</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Universitaria Integrata di Trieste</name>
      <address>
        <city>Trieste</city>
        <zip>34125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCM Medical Group, PSC</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <results_first_submitted>October 21, 2022</results_first_submitted>
  <results_first_submitted_qc>November 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 15, 2022</results_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Genital Psoriasis</keyword>
  <keyword>CC-10004</keyword>
  <keyword>Apremilast</keyword>
  <keyword>Plaque Psoriasis</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>March 3, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03777436/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>October 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03777436/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at 49 centers in Belgium, Canada, France, Germany, Italy, and the United States from February 2019 to February 2022.</recruitment_details>
      <pre_assignment_details>Participants were randomized in a 1:1 ratio to receive either apremilast or matched placebo for the first 16 weeks (Placebo-controlled Phase) of the study. At Week 16, eligible participants may have continued on active treatment by entering a 16-week extension phase (Apremilast Extension Phase). Total treatment duration = 32 weeks.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo-controlled Phase: Placebo</title>
          <description>Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).</description>
        </group>
        <group group_id="P2">
          <title>Placebo-controlled Phase: Apremilast 30 mg</title>
          <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
        </group>
        <group group_id="P3">
          <title>Apremilast Extension Phase: Apremilast 30 mg</title>
          <description>Eligible participants who completed the Placebo-controlled Phase entered the Apremilast Extension Phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Placebo-controlled Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="146"/>
                <participants group_id="P2" count="143"/>
                <participants group_id="P3" count="0">This arm was not included in the Placebo-controlled Phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Took at Least 1 Dose of Investigational Product (IP)</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="143"/>
                <participants group_id="P3" count="0">This arm was not included in the Placebo-controlled Phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="119"/>
                <participants group_id="P3" count="0">This arm was not included in the Placebo-controlled Phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="0"/>
              </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="10"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </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 group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to COVID-19 control measures</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Apremilast Extension Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">This arm was not included in the Apremilast Extension Phase.</participants>
                <participants group_id="P2" count="0">This arm was not included in the Apremilast Extension Phase.</participants>
                <participants group_id="P3" count="229">1 participant did not enter the Apremilast Extension Phase as they were lost to follow-up.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Took at Least 1 Dose of IP</title>
              <participants_list>
                <participants group_id="P1" count="0">This arm was not included in the Apremilast Extension Phase.</participants>
                <participants group_id="P2" count="0">This arm was not included in the Apremilast Extension Phase.</participants>
                <participants group_id="P3" count="228"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">This arm was not included in the Apremilast Extension Phase.</participants>
                <participants group_id="P2" count="0">This arm was not included in the Apremilast Extension Phase.</participants>
                <participants group_id="P3" count="201"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="13"/>
              </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="0"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intent-to-treat (ITT) analysis set consisted of all participants who are randomized regardless of whether the participant received investigational product (IP).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo-controlled Phase: Placebo</title>
          <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
        </group>
        <group group_id="B2">
          <title>Placebo-controlled Phase: Apremilast 30 mg</title>
          <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</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="146"/>
            <count group_id="B2" value="143"/>
            <count group_id="B3" value="289"/>
          </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="46.4" spread="14.38"/>
                    <measurement group_id="B2" value="43.5" spread="13.36"/>
                    <measurement group_id="B3" value="45.0" spread="13.93"/>
                  </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="44"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="256"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="262"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Modified Static Physician Global Assessment of Genitalia (sPGA-G) Score</title>
          <description>The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the three primary signs of the disease: erythema, plaque elevation, and scaling.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>3 (Moderate)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 (Severe)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Modified sPGA-G Response at Week 16</title>
        <description>The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling.&#xD;
A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.&#xD;
Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.</description>
        <time_frame>Baseline and Week 16 of the Placebo-controlled Phase</time_frame>
        <population>The ITT analysis set consisted of all participants who are randomized regardless of whether the participant received IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-controlled Phase: Placebo</title>
            <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
          <group group_id="O2">
            <title>Placebo-controlled Phase: Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Modified sPGA-G Response at Week 16</title>
          <description>The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling.&#xD;
A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.&#xD;
Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.</description>
          <population>The ITT analysis set consisted of all participants who are randomized regardless of whether the participant received IP.</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="146"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5" lower_limit="12.7" upper_limit="26.3"/>
                    <measurement group_id="O2" value="39.6" lower_limit="31.2" upper_limit="48.0"/>
                  </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>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted difference</param_type>
            <param_value>20.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.2</ci_lower_limit>
            <ci_upper_limit>30.9</ci_upper_limit>
            <estimate_desc>Adjusted difference is the weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16</title>
        <description>The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.&#xD;
An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.&#xD;
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.</description>
        <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
        <population>The ITT analysis set consisted of all participants who are randomized regardless of whether the participant received IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-controlled Phase: Placebo</title>
            <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
          <group group_id="O2">
            <title>Placebo-controlled Phase: Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16</title>
          <description>The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.&#xD;
An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.&#xD;
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.</description>
          <population>The ITT analysis set consisted of all participants who are randomized regardless of whether the participant received IP.</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="146"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="2.7" upper_limit="11.2"/>
                    <measurement group_id="O2" value="22.2" lower_limit="15.0" upper_limit="29.3"/>
                  </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>0.0004</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Adjusted difference</param_type>
            <param_value>15.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.9</ci_lower_limit>
            <ci_upper_limit>23.6</ci_upper_limit>
            <estimate_desc>Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16</title>
        <description>The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.&#xD;
A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline.&#xD;
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.</description>
        <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
        <population>ITT analysis set with Baseline GPI-NRS score ≥ 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-controlled Phase: Placebo</title>
            <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
          <group group_id="O2">
            <title>Placebo-controlled Phase: Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16</title>
          <description>The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.&#xD;
A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline.&#xD;
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.</description>
          <population>ITT analysis set with Baseline GPI-NRS score ≥ 4.</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="121"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" lower_limit="11.9" upper_limit="27.4"/>
                    <measurement group_id="O2" value="47.3" lower_limit="37.9" upper_limit="56.6"/>
                  </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>
            <param_type>Adjusted difference</param_type>
            <param_value>27.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.4</ci_lower_limit>
            <ci_upper_limit>39.3</ci_upper_limit>
            <estimate_desc>Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Affected Body Surface Area (BSA) at Week 16</title>
        <description>The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or &quot;handprints&quot; (each entire palmar surface or &quot;handprint&quot; equates to approximately 1% of total BSA).&#xD;
A negative change from Baseline indicates a reduction of affected BSA.&#xD;
Based on mixed-effect model for repeated measures (MMRM) model.</description>
        <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
        <population>ITT analysis set with Baseline and at least one post-baseline value at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-controlled Phase: Placebo</title>
            <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
          <group group_id="O2">
            <title>Placebo-controlled Phase: Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Affected Body Surface Area (BSA) at Week 16</title>
          <description>The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or &quot;handprints&quot; (each entire palmar surface or &quot;handprint&quot; equates to approximately 1% of total BSA).&#xD;
A negative change from Baseline indicates a reduction of affected BSA.&#xD;
Based on mixed-effect model for repeated measures (MMRM) model.</description>
          <population>ITT analysis set with Baseline and at least one post-baseline value at Week 16.</population>
          <units>Change in percentage of affected BSA</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="111"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.79" spread="0.669"/>
                    <measurement group_id="O2" value="-4.12" spread="0.664"/>
                  </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>0.0005</p_value>
            <method>MMRM</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-3.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.942</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.18</ci_lower_limit>
            <ci_upper_limit>-1.47</ci_upper_limit>
            <estimate_desc>Based on MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16</title>
        <description>The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No), and if &quot;No,&quot; then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot).&#xD;
Total scores have a possible range of 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life.&#xD;
A negative change from Baseline indicates an improvement in health-related quality of life scores.</description>
        <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
        <population>ITT analysis set with Baseline and at least one post-baseline value at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-controlled Phase: Placebo</title>
            <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
          <group group_id="O2">
            <title>Placebo-controlled Phase: Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16</title>
          <description>The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No), and if &quot;No,&quot; then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot).&#xD;
Total scores have a possible range of 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life.&#xD;
A negative change from Baseline indicates an improvement in health-related quality of life scores.</description>
          <population>ITT analysis set with Baseline and at least one post-baseline value at Week 16.</population>
          <units>Scores 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="107"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="0.57"/>
                    <measurement group_id="O2" value="-5.3" spread="0.55"/>
                  </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>0.0008</p_value>
            <method>MMRM</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-2.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.79</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
            <estimate_desc>Based on MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16</title>
        <description>The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable.&#xD;
Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).&#xD;
A negative change from Baseline indicates an improvement in genital psoriasis symptoms.</description>
        <time_frame>Baseline and Week 16 of the placebo-controlled phase</time_frame>
        <population>ITT analysis set with Baseline and at least one post-baseline value at Week 16.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-controlled Phase: Placebo</title>
            <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
          <group group_id="O2">
            <title>Placebo-controlled Phase: Apremilast 30 mg</title>
            <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16</title>
          <description>The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable.&#xD;
Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).&#xD;
A negative change from Baseline indicates an improvement in genital psoriasis symptoms.</description>
          <population>ITT analysis set with Baseline and at least one post-baseline value at Week 16.</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="107"/>
                <count group_id="O2" value="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="1.85"/>
                    <measurement group_id="O2" value="-20.5" spread="1.83"/>
                  </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>MMRM</method>
            <param_type>Difference</param_type>
            <param_value>-15.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.60</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.3</ci_lower_limit>
            <ci_upper_limit>-10.0</ci_upper_limit>
            <estimate_desc>Based on MMRM model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to a maximum of 41.4 weeks</time_frame>
      <desc>The safety analysis set consisted of all participants who were randomized and received at least one dose of IP.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo-controlled Phase: Placebo</title>
          <description>Participants received placebo as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
        </group>
        <group group_id="E2">
          <title>Placebo-controlled Phase: Apremilast 30 mg</title>
          <description>Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).</description>
        </group>
        <group group_id="E3">
          <title>Apremilast Extension Phase: Apremilast 30 mg</title>
          <description>Eligible participants who completed the Placebo-controlled Phase entered the Apremilast Extension Phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</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="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</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="39" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="53" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="145"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="229"/>
              </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/NCT03777436
org study id: CC-10004-PSOR-025
secondary id: U1111-1224-6850
secondary id: 2018-002608-15
nct id: NCT03777436
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to
      evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital
      psoriasis (modified sPGA-G ≥3, moderate or severe).

      Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1
      to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
The study will consist of four phases:

        -  Screening Phase - up to 35 days

        -  Double-blind Placebo-controlled Phase - Weeks 0 to 16

           - Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or
           placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.

        -  Apremilast Extension Phase - Weeks 16 to 32

           - All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects
           will maintain this dosing through Week 32.

        -  Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational
           Follow-up Phase for all subjects who complete the study or discontinue the study early.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With a Modified sPGA-G Response at Week 16
time frame: Baseline and Week 16 of the Placebo-controlled Phase
description: The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling.
A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.
Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
time frame: Baseline and Week 16 of the placebo-controlled phase
description: The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.
An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.
measure: Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16
time frame: Baseline and Week 16 of the placebo-controlled phase
description: The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.
A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline.
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.
measure: Change From Baseline in Affected Body Surface Area (BSA) at Week 16
time frame: Baseline and Week 16 of the placebo-controlled phase
description: The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total BSA).
A negative change from Baseline indicates a reduction of affected BSA.
Based on mixed-effect model for repeated measures (MMRM) model.
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
time frame: Baseline and Week 16 of the placebo-controlled phase
description: The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being 0 (not at all), 1 (a little) and 2 (a lot).
Total scores have a possible range of 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life.
A negative change from Baseline indicates an improvement in health-related quality of life scores.
measure: Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16
time frame: Baseline and Week 16 of the placebo-controlled phase
description: The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable.
Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).
A negative change from Baseline indicates an improvement in genital psoriasis symptoms.
arm group label: Arm A- Apremilast with Placebo
arm group type: Experimental
description: Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks
arm group label: Arm B - Apremilast 30 mg
arm group type: Experimental
description: All subjects will receive apremilast 30 mg tablets orally twice daily after the Week 16 Visit through the end of the Apremilast Extension Phase of the study
intervention type: Drug
intervention name: Apremilast
description: Oral
arm group label: Arm A- Apremilast with Placebo
arm group label: Arm B - Apremilast 30 mg
other name: CC-10004, Otezla
intervention type: Other
intervention name: Placebo
description: Oral
arm group label: Arm A- Apremilast with Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: France
country: Germany
country: Italy
country: Puerto Rico
country: United States
country: Austria
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
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: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 