Clinical Trial: A Phase 2 Study With CC-220 in Skin Sarcoidosis
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis
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 Summary:
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
Sponsor: Celgene Corporation
Current Primary Outcome: Number of participants with adverse events (AEs) [ Time Frame: Up to 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
- Improvement in lesion induration [ Time Frame: Week 12 ]Change from baseline in lesion induration via dermascope compared to Week 12
- 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.
- 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).
- 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).
- 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.
- 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
- 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
- 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
- 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).
Original Secondary Outcome: Same as current
Information By: Celgene Corporation
Dates:
Date Received: July 15, 2014
Date Started: November 2014
Date Completion: June 2017
Last Updated: September 27, 2016
Last Verified: September 2016