A Phase 2 Study With CC-220 in Skin Sarcoidosis

A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis

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

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

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.