A Study of the Efficacy, Safety, and Tolerability of A-623 Administration in Subjects With Systemic Lupus Erythematosus
Sponsor
Anthera Pharmaceuticals, Inc.
25801 Industrial Blvd
Suite B
Hayward, CA 94545
USA
Purpose
The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
Study Design
A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus. Subjects will be randomized to receive subcutaneous doses of A-623 (at one of 3 dose levels) or placebo for up to 52 weeks.
All enrolled subjects will be allowed to continue his or her standard-of-care oral medications for treatment of SLE throughout the study. SLE disease activity and management will be monitored and recorded throughout the study. The primary objective of this study is to evaluate the clinical efficacy of A-623 as measured by the systemic lupus erythematosus (SLE) responder index (SRI) in subjects with serologically active SLE. The SRI is defined as >4 point improvement in the Safety of Estrogen in Lupus Erythematosus National Assessment – Systematic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score AND no new British Isles Lupus Activity Guide (BILAG) 1A or 2B organ domain flares AND no worsening in Physician’s Global Assessment (PGA) (<0.3 point increase). Additional assessments of time to first SLE flare, FACIT-fatigue score, reduction in prednisone dose, and biomarker changes including B cell counts, will be made.
