A Phase 2 Study With CC-220 in Skin Sarcoidosis
Study Details
Study Description
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 |
|---|---|---|
|
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
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events (AEs) [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
- Improvement in modified Sarcoidosis Activity and Severity Index [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 [Week 12]
Change from baseline in lesion induration via dermascope compared to Week 12
- Improvement in sarcoidosis disease markers [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 [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) [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) [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 [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 [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 [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 [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).
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Yufang Lu, MD, PhD, Celgene Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-220-SAR-001
- 2014-001065-27