<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/NCT03764475</url>
  </required_header>
  <id_info>
    <org_study_id>ARQ-151-202</org_study_id>
    <nct_id>NCT03764475</nct_id>
  </id_info>
  <brief_title>Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis</brief_title>
  <official_title>A Phase 2, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Adult Subjects With Chronic Plaque Psoriasis Who Have Completed Preceding Study ARQ-151-201 Phase 2 Randomized Controlled Trial (Cohort 1) and Non-ARQ-151-201 Subjects (Cohort 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arcutis Biotherapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arcutis Biotherapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects&#xD;
      with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study&#xD;
      medication will be applied by the qualifying subjects topically once daily for 52 weeks at&#xD;
      home. Periodic clinic visits will include assessments for clinical safety, application site&#xD;
      reactions, and disease improvement or progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201&#xD;
      (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in&#xD;
      ARQ-151-201.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">October 8, 2020</completion_date>
  <primary_completion_date type="Actual">October 8, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Note: Subjects that consent to enter this open-label safety study have previously completed a companion study (ARQ-151-201 Phase 2 randomized controlled trial)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs [TEAEs]) in ARQ-151-202 are presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'</measure>
    <time_frame>Weeks 12, 24, 36, and 52</time_frame>
    <description>The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response in Participants Achieving 'Clear' IGA Score</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of &quot;Clear' or 'Almost Clear'</measure>
    <time_frame>Weeks 12, 24, 36, and 52</time_frame>
    <description>The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75)</measure>
    <time_frame>Baseline and Weeks 12, 24, 36, and 52</time_frame>
    <description>The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">332</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>Long-term Safety of Roflumilast</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 52 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Roflumilast</intervention_name>
    <description>Roflumilast cream 0.3% for topical application</description>
    <arm_group_label>Long-term Safety of Roflumilast</arm_group_label>
    <other_name>ARQ-151</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants legally competent to sign and give informed consent&#xD;
&#xD;
          2. Males and females ages 18 years and older&#xD;
&#xD;
          3. Subjects with chronic plaque psoriasis who met eligibility criteria for ARQ-151-201,&#xD;
             successfully completed ARQ-151-201 through Week 12, and are able to enroll into this&#xD;
             long-term safety study on the Week 12 visit of the previous study (ARQ-151-201).&#xD;
&#xD;
          4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at&#xD;
             all study visits. In addition, sexually active FOCBP must agree to use at least one&#xD;
             form of highly effective contraception throughout the trial. Highly effective forms of&#xD;
             contraception include: oral/implant/injectable/transdermal contraceptives,&#xD;
             intrauterine device, or partner's vasectomy. If barrier methods are used (e.g., condom&#xD;
             with spermicide, diaphragm with spermicide), then 2 forms of conception are required.&#xD;
             The use of abstinence as a contraceptive measure is acceptable as long as this is a&#xD;
             consistent part of a lifestyle choice and a backup method has been identified if the&#xD;
             subject becomes sexually active.&#xD;
&#xD;
          5. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have&#xD;
             undergone surgical sterilization (permanent sterilization methods include&#xD;
             hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal&#xD;
             ligation or bilateral salpingectomy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that&#xD;
             precluded further treatment with ARQ-151 cream in Study ARQ-151-201.&#xD;
&#xD;
          2. Subjects that use any Excluded Medications and Treatments&#xD;
&#xD;
          3. Current diagnosis of guttate, erythrodermic/exfoliative, palmoplantar, or pustular&#xD;
             psoriasis.&#xD;
&#xD;
          4. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g.,&#xD;
             indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole,&#xD;
             nefazodone, saquinavir, suboxone and telithromycin during the study period.&#xD;
&#xD;
          5. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g.,&#xD;
             efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital),&#xD;
             phenytoin, and rifampin during the study period.&#xD;
&#xD;
          6. Known or suspected:&#xD;
&#xD;
               -  severe renal insufficiency or severe hepatic disorders&#xD;
&#xD;
               -  hypersensitivity to component(s) of the investigational products&#xD;
&#xD;
               -  history of severe depression, suicidal ideation&#xD;
&#xD;
          7. Females who are pregnant, wishing to become pregnant during the study, or are&#xD;
             breast-feeding.&#xD;
&#xD;
          8. Subjects with any serious medical condition or laboratory abnormality that would&#xD;
             prevent study participation or place the subject at significant risk, as determined by&#xD;
             the Investigator.&#xD;
&#xD;
          9. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation&#xD;
             of study medication.&#xD;
&#xD;
         10. Current or a history of cancer within 5 years with the exception of fully treated skin&#xD;
             basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the&#xD;
             cervix.&#xD;
&#xD;
         11. Subjects who are unable to communicate, read or understand the local language, or who&#xD;
             display another condition, which in the Investigator's opinion, makes them unsuitable&#xD;
             for clinical study participation.&#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>David Berk, MD</last_name>
    <role>Study Director</role>
    <affiliation>Arcutis Biotherapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arcutis Clinical Site 35</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 29</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 28</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 27</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 12</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 16</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 21</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 34</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 33</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 20</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 22</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 14</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 39</name>
      <address>
        <city>Bexley</city>
        <state>Ohio</state>
        <zip>43209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 15</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 19</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 37</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 13</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 23</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 24</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 31</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 18</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3R 6A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 11</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 0C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 38</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3M 3Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 10</name>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <zip>L1S 7K8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 25</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6H 5L5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 26</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <zip>L3P 1X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 32</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6J 7W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 17</name>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <zip>K9J 5K2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 30</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcutis Clinical Site 36</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 1E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <results_first_submitted>June 30, 2022</results_first_submitted>
  <results_first_submitted_qc>July 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 18, 2022</results_first_posted>
  <disposition_first_submitted>September 29, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>July 27, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 18, 2022</disposition_first_posted>
  <last_update_submitted>August 31, 2022</last_update_submitted>
  <last_update_submitted_qc>August 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <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>April 12, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03764475/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, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03764475/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at 30 study sites in the United States and Canada.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: Study 201 Participants</title>
          <description>This arm consisted of participants who previously participated in Study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2: Non-study 201 Participants</title>
          <description>This arm consisted of participants who did not previously participate in Study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="230"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>COVID-19 Disruption</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline was defined as the last observation prior to administration of ARQ-151 cream. Thus the baseline assessments for participants in Cohort 1 assigned to ARQ-151 cream occurred in the ARQ-151-201 study, whereas baseline occurred in this study (ARQ-151-202) for vehicle cream participants in the 201 study and Cohort 2 participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: Study 201 Participants</title>
          <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2: Non-study 201 Participants</title>
          <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.</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="230"/>
            <count group_id="B2" value="102"/>
            <count group_id="B3" value="332"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.3" spread="13.52"/>
                    <measurement group_id="B2" value="52.7" spread="15.64"/>
                    <measurement group_id="B3" value="54.5" spread="14.23"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="182"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="183"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple/Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="102"/>
                    <count group_id="B3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Modified Psoriasis Area Severity Index (mPASI)</title>
          <description>The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.</description>
          <population>One participant in Cohort 2 did not have a baseline mPASI assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="230"/>
                    <count group_id="B2" value="101"/>
                    <count group_id="B3" value="331"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.42" spread="3.700"/>
                    <measurement group_id="B2" value="4.50" spread="3.821"/>
                    <measurement group_id="B3" value="5.14" spread="3.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)</title>
        <description>An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs [TEAEs]) in ARQ-151-202 are presented.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>All randomized participants who received ≥1 dose of study treatment are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Study 201 Participants</title>
            <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast (ARQ-151) cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Non-study 201 Participants</title>
            <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled after the time of amendment 1 in this study. Participants applied roflumilast cream 0.3% once daily for 52 weeks to monitor long-term safety.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)</title>
          <description>An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs [TEAEs]) in ARQ-151-202 are presented.</description>
          <population>All randomized participants who received ≥1 dose of study treatment are included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)</title>
        <description>An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>All randomized participants who received ≥1 dose of study drug are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Study 201 Participants</title>
            <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either ARQ-151 cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied ARQ-151 cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Non-study 201 Participants</title>
            <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied ARQ-151 cream 0.3% once daily for 52 weeks for long-term safety monitoring.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)</title>
          <description>An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.</description>
          <population>All randomized participants who received ≥1 dose of study drug are included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'</title>
        <description>The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.</description>
        <time_frame>Weeks 12, 24, 36, and 52</time_frame>
        <population>All participants who received ≥1 dose of study drug and have data available at the relevant time points are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Study 201 Participants</title>
            <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Non-study 201 Participants</title>
            <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'</title>
          <description>The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.</description>
          <population>All participants who received ≥1 dose of study drug and have data available at the relevant time points are included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="209"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="209"/>
                    <count group_id="O2" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response in Participants Achieving 'Clear' IGA Score</title>
        <description>The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented.</description>
        <time_frame>Up to 52 weeks</time_frame>
        <population>All participants who received ≥1 dose of study drug and achieved an IGA score of 'clear' are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Study 201 Participants</title>
            <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Non-study 201 Participants</title>
            <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response in Participants Achieving 'Clear' IGA Score</title>
          <description>The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented.</description>
          <population>All participants who received ≥1 dose of study drug and achieved an IGA score of 'clear' are included.</population>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="4.1" upper_limit="9.0"/>
                    <measurement group_id="O2" value="12.4" lower_limit="3.0" upper_limit="NA">Upper bound of the 95% CI was not estimable due to low number of cases.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of &quot;Clear' or 'Almost Clear'</title>
        <description>The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.</description>
        <time_frame>Weeks 12, 24, 36, and 52</time_frame>
        <population>All participants who received ≥1 dose of study drug, have intertriginous area involvement, and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus I-IGA was not assessed in a subset of participants in Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Study 201 Participants</title>
            <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Non-study 201 Participants</title>
            <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of &quot;Clear' or 'Almost Clear'</title>
          <description>The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.</description>
          <population>All participants who received ≥1 dose of study drug, have intertriginous area involvement, and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus I-IGA was not assessed in a subset of participants in Cohort 1.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75)</title>
        <description>The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.</description>
        <time_frame>Baseline and Weeks 12, 24, 36, and 52</time_frame>
        <population>All participants who received ≥1 dose of study drug and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus mPASI was not assessed in a subset of participants in Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Study 201 Participants</title>
            <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: Non-study 201 Participants</title>
            <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75)</title>
          <description>The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.</description>
          <population>All participants who received ≥1 dose of study drug and have data available at the relevant time points are included. This endpoint was added at protocol amendment 1, and thus mPASI was not assessed in a subset of participants in Cohort 1.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="165"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 52 weeks</time_frame>
      <desc>All participants who received ≥1 dose of study drug are included.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: Study 201 Participants</title>
          <description>This arm consisted of participants who previously participated in study ARQ-151-201 and received either roflumilast cream (0.15% or 0.3%) or vehicle cream, and agreed to enroll in the 202 study. Upon completing the 201 study, participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring in the 202 study.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2: Non-study 201 Participants</title>
          <description>This arm consisted of participants who did not previously participate in study ARQ-151-201, and were enrolled in the 202 study after the time of amendment 1. Participants applied roflumilast cream 0.3% once daily for 52 weeks for long-term safety monitoring.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</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="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>SARS-CoV-2 test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="15" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="230"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="102"/>
              </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 Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Arcutis Medical Information</name_or_title>
      <organization>Arcutis Biotherapeutics</organization>
      <phone>+1 (844) 692-6729</phone>
      <email>medinfo@arcutis.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/NCT03764475
org study id: ARQ-151-202
nct id: NCT03764475
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects
      with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study
      medication will be applied by the qualifying subjects topically once daily for 52 weeks at
      home. Periodic clinic visits will include assessments for clinical safety, application site
      reactions, and disease improvement or progression.
Cohort 1 of this study consisted of participants who previously completed study ARQ-151-201
      (NCT03638258), and Cohort 2 consisted of participants who were not previously enrolled in
      ARQ-151-201.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Note: Subjects that consent to enter this open-label safety study have previously completed a companion study (ARQ-151-201 Phase 2 randomized controlled trial)
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)
time frame: Up to 52 weeks
description: An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs [TEAEs]) in ARQ-151-202 are presented.
measure: Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
time frame: Up to 52 weeks
description: An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
measure: Number of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
time frame: Weeks 12, 24, 36, and 52
description: The number of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 12 is reported. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.
measure: Duration of Response in Participants Achieving 'Clear' IGA Score
time frame: Up to 52 weeks
description: The median time to re-starting study therapy among participants who achieve a 'clear' IGA score and stop treatment to all lesions is presented.
measure: Number of Participants With Intertriginous Area Involvement Achieving an Intertriginous Area Investigator Global Assessment (I-IGA) Score of "Clear' or 'Almost Clear'
time frame: Weeks 12, 24, 36, and 52
description: The number of participants who had intertriginous area involvement with an I-IGA score of 'clear' or 'almost clear' is presented. The I-IGA is 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater plaque severity.
measure: Number of Participants Achieving a 75% Reduction From Baseline in Modified Psoriasis Severity Index (mPASI-75)
time frame: Baseline and Weeks 12, 24, 36, and 52
description: The number of participants achieving a 75% reduction in mPASI (eg, mPASI-75) score relative to baseline is presented. The mPASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0 ('no disease') to 72 ('maximal disease'), with higher scores indicating greater severity.
arm group label: Long-term Safety of Roflumilast
arm group type: Other
description: Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 52 weeks
intervention type: Drug
intervention name: Roflumilast
description: Roflumilast cream 0.3% for topical application
arm group label: Long-term Safety of Roflumilast
other name: ARQ-151
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Berk, MD
role: Study Director
affiliation: Arcutis Biotherapeutics
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
provided document: 
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baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 