A Phase 2 Study With CC-220 in Skin Sarcoidosis

• Status: Withdrawn
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

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.