Clinical Trial: Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus
Brief 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).
Detailed Summary:
Sponsor: EMD Serono
Current Primary Outcome: Percentage of subjects with SLE responder index (SRI) response at Week 24 compared to screening [ Time Frame: Screening and Week 24 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of subjects at Week 24 whose prednisone-equivalent corticosteroid dose has reduced from Screening by >= 25 percent and to a dose of =< 7.5 milligram per day (mg/day), and have no BILAG A or 2B flare in disease activity during Weeks 16 to 24 [ Time Frame: Screening and Week 24 ]
- Percentage of subjects in the patient global impression of change (PGIC) categories at Week 24 [ Time Frame: Week 24 ]
- Change from screening visit to Week 24 in prednisone-equivalent corticosteroid (CS) daily dose [ Time Frame: Screening and Week 24 ]
- Time to first SRI response during the treatment period [ Time Frame: 24 Weeks ]
- Percentage of subjects responding to treatment according to British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) [ Time Frame: Week 24 ]
- Change from Day 1 in medical outcomes study 36-item short form health survey (SF-36)-physical component summary (PCS) and mental component summary (MCS) [ Time Frame: Week 24 ]
- Number of subjects with adverse events (AEs) [ Time Frame: Screening up to 48 weeks ]
Original Secondary Outcome: Same as current
Information By: EMD Serono
Dates:
Date Received: October 24, 2013
Date Started: December 2013
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017