Status:
WITHDRAWN
A Phase 2 Study With CC-220 in Skin Sarcoidosis
Lead Sponsor:
Celgene
Conditions:
Sarcoidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.
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 cohor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02192489
Start Date
November 1 2014
End Date
June 30 2017
Last Update
November 12 2019
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