<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/NCT02192489</url>
  </required_header>
  <id_info>
    <org_study_id>CC-220-SAR-001</org_study_id>
    <secondary_id>2014-001065-27</secondary_id>
    <nct_id>NCT02192489</nct_id>
  </id_info>
  <brief_title>A Phase 2 Study With CC-220 in Skin Sarcoidosis</brief_title>
  <official_title>A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy&#xD;
      of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, sequential,&#xD;
      dose-ascending, safety and tolerability study in subjects with chronic cutaneous sarcoidosis.&#xD;
&#xD;
      Two dose cohorts of CC-220 (Cohort 1: 0.3 mg by mouth (PO) every day (QD) or matching placebo&#xD;
      and Cohort 2: 0.6 mg PO QD or matching placebo) will be evaluated using a sequential,&#xD;
      dose-ascending design&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Administrative&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 1, 2014</start_date>
  <completion_date type="Anticipated">June 30, 2017</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events (AEs)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in modified Sarcoidosis Activity and Severity Index</measure>
    <time_frame>Week 4, 8 and 12</time_frame>
    <description>Proportion of subjects who achieve a ≥ 1-point change in the index lesion as measured by the cutaneous sarcoidosis outcome instrument (modified Sarcoidosis Activity and Severity Index) as compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in lesion induration</measure>
    <time_frame>Week 12</time_frame>
    <description>Change from baseline in lesion induration via dermascope compared to Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in sarcoidosis disease markers</measure>
    <time_frame>Weeks 4, 8, 12</time_frame>
    <description>Change from baseline in sarcoidosis disease markers: serum angiotensin converting enzyme (ACE), Immunoglobulin G (IgG) levels, 25-hydroxy vitamin D (25-OH-vit D), and 1,25-dihydroxy vitamin D (1,25-vit D) as compared to Weeks 4, 8 and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics- Maximum Plasma Concentration (Cmax) of CC-220 After Single and Multiple Doses</measure>
    <time_frame>Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose</time_frame>
    <description>Maximum observed plasma concentration after a single dose on Day 1 or multiple doses on Day 29).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Time Point After Single and Multiple Doses (AUC 0-t)</measure>
    <time_frame>Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose</time_frame>
    <description>Area under the plasma concentration time-curve from time 0 to the last quantifiable concentration at time t following a single dose (day 1) and multiple doses (Day 29) determined using the trapezoidal method (non-compartmental analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Single and Multiple Doses (AUC0-inf)</measure>
    <time_frame>Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose</time_frame>
    <description>The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for CC-220 after a single dose on day 1 and multiple doses on Day 29, calculated by the linear trapezoidal rule and extrapolated to infinity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Terminal Phase Half-life (t1/2) After Single and Multiple Doses</measure>
    <time_frame>Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose</time_frame>
    <description>Terminal phase elimination half-life (t1/2) after a single dose on day 1 and multiple doses on Day 29</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Apparent Volume of Distribution (Vz/f) After Single and Multiple Doses</measure>
    <time_frame>Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose</time_frame>
    <description>Apparent volume of distribution after a single dose on day 1 and multiple doses on Day 29, based on the terminal phase after a orally administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Apparent Total Clearance of CC-220 (CL/F) After Single and Multiple Doses</measure>
    <time_frame>Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose</time_frame>
    <description>The apparent total clearance after a single dose on Day 1 and multiple doses Day 29, calculated as Dose/AUC0-inf</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) After Single and Multiple Doses</measure>
    <time_frame>Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose</time_frame>
    <description>The time to first maximum observed plasma concentration of CC-220 after a single dose (Day 1) or multiple doses (Day 29).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Sarcoidosis</condition>
  <arm_group>
    <arm_group_label>CC-220 0.3mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CC-220 0.6mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CC-220 0.6mg capsules by PO daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identically matching placebo PO daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-220 0.3 mg Daily</intervention_name>
    <arm_group_label>CC-220 0.3mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-220 0.6mg Daily</intervention_name>
    <arm_group_label>CC-220 0.6mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Males or females aged ≥ 18 years at the time of consent.&#xD;
&#xD;
          -  Have chronic cutaneous sacrcoidosis (CCS) prior to consent&#xD;
&#xD;
          -  Have active cutaneous sarcoidosis lesion(s) at screening&#xD;
&#xD;
          -  Forced vital capacity of ≥ 45% of predicted normal value at screening.&#xD;
&#xD;
          -  Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min.&#xD;
&#xD;
          -  Females of childbearing potential must have negative pregnancy tests prior to starting&#xD;
             study therapy and agree to either commit to true abstinence or use effective&#xD;
             contraception.&#xD;
&#xD;
          -  Male subjects must practice true abstinence or agree to use a condom even if he has&#xD;
             undergone a successful vasectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive tuberculosis test at screening.&#xD;
&#xD;
          -  History of inadequately treated tuberculosis&#xD;
&#xD;
          -  History of Human Immunodeficiency Virus (HIV) and/or Common Variable Immunodeficiency&#xD;
             Disease.&#xD;
&#xD;
          -  History of alcohol or drug abuse&#xD;
&#xD;
          -  History or current peripheral neuropathy&#xD;
&#xD;
          -  Current uveitis or any other clinically significant ophthalmological finding&#xD;
&#xD;
          -  Currently require therapy for precapillary pulmonary hypertension.&#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>Yufang Lu, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Celgene Corporation</affiliation>
  </overall_official>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>November 7, 2019</last_update_submitted>
  <last_update_submitted_qc>November 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Cutaneous Sarcoidosis</keyword>
  <keyword>Cutaneous Sarcoidosis</keyword>
  <keyword>Skin Sarcoidosis</keyword>
  <keyword>Sarcoidosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02192489
org study id: CC-220-SAR-001
secondary id: 2014-001065-27
nct id: NCT02192489
lead sponsor: 
has dmc: No
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy
      of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, sequential,
      dose-ascending, safety and tolerability study in subjects with chronic cutaneous sarcoidosis.

      Two dose cohorts of CC-220 (Cohort 1: 0.3 mg by mouth (PO) every day (QD) or matching placebo
      and Cohort 2: 0.6 mg PO QD or matching placebo) will be evaluated using a sequential,
      dose-ascending design
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with adverse events (AEs)
time frame: Up to 12 weeks
description: An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health.
measure: Improvement in modified Sarcoidosis Activity and Severity Index
time frame: Week 4, 8 and 12
description: Proportion of subjects who achieve a ≥ 1-point change in the index lesion as measured by the cutaneous sarcoidosis outcome instrument (modified Sarcoidosis Activity and Severity Index) as compared to baseline
measure: Improvement in lesion induration
time frame: Week 12
description: Change from baseline in lesion induration via dermascope compared to Week 12
measure: Improvement in sarcoidosis disease markers
time frame: Weeks 4, 8, 12
description: Change from baseline in sarcoidosis disease markers: serum angiotensin converting enzyme (ACE), Immunoglobulin G (IgG) levels, 25-hydroxy vitamin D (25-OH-vit D), and 1,25-dihydroxy vitamin D (1,25-vit D) as compared to Weeks 4, 8 and 12.
measure: Pharmacokinetics- Maximum Plasma Concentration (Cmax) of CC-220 After Single and Multiple Doses
time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
description: Maximum observed plasma concentration after a single dose on Day 1 or multiple doses on Day 29).
measure: Pharmacokinetics - Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Time Point After Single and Multiple Doses (AUC 0-t)
time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
description: Area under the plasma concentration time-curve from time 0 to the last quantifiable concentration at time t following a single dose (day 1) and multiple doses (Day 29) determined using the trapezoidal method (non-compartmental analysis).
measure: Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Single and Multiple Doses (AUC0-inf)
time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
description: The area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for CC-220 after a single dose on day 1 and multiple doses on Day 29, calculated by the linear trapezoidal rule and extrapolated to infinity.
measure: Pharmacokinetics - Terminal Phase Half-life (t1/2) After Single and Multiple Doses
time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
description: Terminal phase elimination half-life (t1/2) after a single dose on day 1 and multiple doses on Day 29
measure: Pharmacokinetics - Apparent Volume of Distribution (Vz/f) After Single and Multiple Doses
time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
description: Apparent volume of distribution after a single dose on day 1 and multiple doses on Day 29, based on the terminal phase after a orally administration
measure: Pharmacokinetics - Apparent Total Clearance of CC-220 (CL/F) After Single and Multiple Doses
time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
description: The apparent total clearance after a single dose on Day 1 and multiple doses Day 29, calculated as Dose/AUC0-inf
measure: Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) After Single and Multiple Doses
time frame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
description: The time to first maximum observed plasma concentration of CC-220 after a single dose (Day 1) or multiple doses (Day 29).
arm group label: CC-220 0.3mg
arm group type: Experimental
description: CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks
arm group label: CC-220 0.6mg
arm group type: Experimental
description: CC-220 0.6mg capsules by PO daily for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Identically matching placebo PO daily for 12 weeks
intervention type: Drug
intervention name: CC-220 0.3 mg Daily
arm group label: CC-220 0.3mg
intervention type: Drug
intervention name: CC-220 0.6mg Daily
arm group label: CC-220 0.6mg
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yufang Lu, MD, PhD
role: Study Director
affiliation: Celgene Corporation
responsible party type: Sponsor
mesh term: Sarcoidosis