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A Phase 2 Study With CC-220 in Skin Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192489
Recruitment Status : Withdrawn (Administrative)
First Posted : July 16, 2014
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.

Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: CC-220 0.3 mg Daily Drug: CC-220 0.6mg Daily Drug: Placebo Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis
Estimated Study Start Date : November 1, 2014
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: CC-220 0.3mg
CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks
Drug: CC-220 0.3 mg Daily
Experimental: CC-220 0.6mg
CC-220 0.6mg capsules by PO daily for 12 weeks
Drug: CC-220 0.6mg Daily
Placebo Comparator: Placebo
Identically matching placebo PO daily for 12 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Improvement in modified Sarcoidosis Activity and Severity Index [ Time Frame: Week 4, 8 and 12 ]
    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

  2. Improvement in lesion induration [ Time Frame: Week 12 ]
    Change from baseline in lesion induration via dermascope compared to Week 12

  3. Improvement in sarcoidosis disease markers [ Time Frame: Weeks 4, 8, 12 ]
    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.

  4. 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 ]
    Maximum observed plasma concentration after a single dose on Day 1 or multiple doses on Day 29).

  5. 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 ]
    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).

  6. 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 ]
    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.

  7. 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 ]
    Terminal phase elimination half-life (t1/2) after a single dose on day 1 and multiple doses on Day 29

  8. 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 ]
    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

  9. 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 ]
    The apparent total clearance after a single dose on Day 1 and multiple doses Day 29, calculated as Dose/AUC0-inf

  10. 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 ]
    The time to first maximum observed plasma concentration of CC-220 after a single dose (Day 1) or multiple doses (Day 29).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Males or females aged ≥ 18 years at the time of consent.

  • Have chronic cutaneous sacrcoidosis (CCS) prior to consent
  • Have active cutaneous sarcoidosis lesion(s) at screening
  • Forced vital capacity of ≥ 45% of predicted normal value at screening.
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min.
  • Females of childbearing potential must have negative pregnancy tests prior to starting study therapy and agree to either commit to true abstinence or use effective contraception.
  • Male subjects must practice true abstinence or agree to use a condom even if he has undergone a successful vasectomy

Exclusion Criteria:

  • Positive tuberculosis test at screening.
  • History of inadequately treated tuberculosis
  • History of Human Immunodeficiency Virus (HIV) and/or Common Variable Immunodeficiency Disease.
  • History of alcohol or drug abuse
  • History or current peripheral neuropathy
  • Current uveitis or any other clinically significant ophthalmological finding
  • Currently require therapy for precapillary pulmonary hypertension.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192489


Sponsors and Collaborators
Celgene
Investigators
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Study Director: Yufang Lu, MD, PhD Celgene Corporation
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02192489    
Other Study ID Numbers: CC-220-SAR-001
2014-001065-27 ( EudraCT Number )
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Keywords provided by Celgene:
Chronic Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Skin Sarcoidosis
Sarcoidosis
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases