A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)

Summary

The primary objective of this study is to evaluate the efficacy of a 200 micrograms (mcg) dose of CEP-33457 compared with placebo in participants with active systemic lupus erythematosus (SLE) as assessed by the proportion of participants achieving a combined clinical response using the SLE responder index (SRI) at Week 24.

Timeline

Start

2010-06-24

Primary completion

2012-01-31

Completion

2012-06-30

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs CEP-33457; p = 0.3989; Odds Ratio (OR) 0.7649 (95% CI 0.4 to 1.4); Regression, Logistic NCT01135459 ↗

Drugs

Indications