A Phase 2 Study With CC-220 in Skin Sarcoidosis

Celgene

Status and phase: Withdrawn; Phase 2

Conditions: Sarcoidosis

Treatments: Drug: Placebo; Drug: CC-220 0.3 mg Daily; Drug: CC-220 0.6mg Daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT02192489

2014-001065-27 (EudraCT Number)

CC-220-SAR-001

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

CC-220 0.3mg

Experimental group

Description:

CC-220 0.3 mg capsules by mouth (PO) daily for 12 weeks

Treatment:

Drug: CC-220 0.3 mg Daily

CC-220 0.6mg

Experimental group

Description:

CC-220 0.6mg capsules by PO daily for 12 weeks

Treatment:

Drug: CC-220 0.6mg Daily

Placebo

Placebo Comparator group

Description:

Identically matching placebo PO daily for 12 weeks

Treatment:

Drug: Placebo