A Phase 2 Study With CC-220 in Skin Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02192489
• Date of registration: 15/07/2014
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: A Phase 2 Study With CC-220 in Skin Sarcoidosis
• Scientific title: A Phase 2A, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential, Dose-Ascending Study Of CC-220 In Subjects With Chronic Cutaneous Sarcoidosis
• Date of first enrolment: November 1, 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02192489
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Contacts

• Name: Yufang Lu, MD, PhD
• Affiliation: Celgene Corporation

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: CC-220 0.3 mg Daily

Drug: CC-220 0.6mg Daily

Drug: Placebo

Primary Outcome(s)

Number of participants with adverse events (AEs) [Time Frame: Up to 12 weeks]

Secondary Outcome(s)

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]

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]

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]

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]

Improvement in lesion induration [Time Frame: Week 12]

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]

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]

Improvement in modified Sarcoidosis Activity and Severity Index [Time Frame: Week 4, 8 and 12]

Improvement in sarcoidosis disease markers [Time Frame: Weeks 4, 8, 12]

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]

Secondary ID(s)

CC-220-SAR-001

2014-001065-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors