Clinical trial NCT02192489: A Phase 2 Study With CC-220 in Skin Sarcoidosis
Official title: A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sarcoidosis
Keywords: Chronic Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Skin Sarcoidosis
Sarcoidosis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Improvement in modified Sarcoidosis Activity and Severity Index
timeFrame: Week 4, 8 and 12
measure: Improvement in lesion induration
timeFrame: Week 12
measure: Improvement in sarcoidosis disease markers
timeFrame: Weeks 4, 8, 12
measure: Pharmacokinetics- Maximum Plasma Concentration (Cmax) of CC-220 After Single and Multiple Doses
timeFrame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
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)
timeFrame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
measure: Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity After Single and Multiple Doses (AUC0-inf)
timeFrame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
measure: Pharmacokinetics - Terminal Phase Half-life (t1/2) After Single and Multiple Doses
timeFrame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
measure: Pharmacokinetics - Apparent Volume of Distribution (Vz/f) After Single and Multiple Doses
timeFrame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
measure: Pharmacokinetics - Apparent Total Clearance of CC-220 (CL/F) After Single and Multiple Doses
timeFrame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
measure: Pharmacokinetics - Time to Maximum Plasma Concentration (Tmax) After Single and Multiple Doses
timeFrame: Day 1 and Day 29 at predose, 1, 2, 3, 4, 6, 8, and 24 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Celgene Corporation
name: Yufang Lu, MD, PhD
role: STUDY_DIRECTOR
References: