Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono

Criteria

Inclusion Criteria:

• Eligible male and female subjects, aged 18 years or older

• Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit

• At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed >= 6 months prior to the screening visit)

• Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Subjects have demyelinating disorder

• Severe central nervous system SLE

• Use of cyclophosphamide within 3 months of the screening visit

• Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day

• Other protocol defined exclusion criteria could apply