NCT03161483

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

Detailed description

The study consists of four phases: * 4-week Screening Phase * 24-week placebo-controlled phase Subjects will receive either 0.45 mg QD, 0.3 mg QD, 0.15 mg QD or placebo for the first 24 weeks of treatment. * 28-week active treatment phase At Week 24, all subjects on placebo will be re-randomized to active treatment. * 52-week long-term extension phase Subjects who complete the treatment phase may be eligible to roll over into a Long-term Extension of up to 52 weeks of treatment. * 4 - 12-week observational follow-up All subjects who complete 52 weeks of treatment or discontinue the study early will enter a post-treatment observation follow-up phase. The Observational Follow-up Phase will consist of one visit 4 weeks following cessation of study drug for all subjects with an additional 12-week Observational Follow-up visit for males only.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	CC-220	CC-220
OTHER	Placebo	Placebo QD PO

Timeline

• Start date: 2017-08-31
• Primary completion: 2021-08-03
• Completion: 2021-08-03
• First posted: 2017-05-19
• Last updated: 2023-06-15
• Results posted: 2021-02-18

Locations

184 sites across 15 countries: United States, Argentina, Belgium, Brazil, Canada, Colombia, France, Germany, Hungary, Italy, Mexico, Poland, Russia, Serbia, Spain

Regulatory

• FDA-regulated drug study