Last updated on March 2019

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


Brief description of study

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 Study 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.
  • 4-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.

Clinical Study Identifier: NCT03161483

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Associate Director Clinical Trial Disclosure

Hospital Universitario de Canarias
La Laguna, Spain
2.1miles
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Recruitment Status: Open


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