Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00624338 | Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) | PHASE2 | COMPLETED | 461 | — | — | Jan 1, 2008 | Oct 1, 2012 | Mar 14, 2016 | 113 | United States, Argentina +27 |
A flare was defined as having an adjudicated BILAG A or B score in any of the 8 organ systems during treatment, or imputed for participants who had premature treatment discontinuation. Discontinuations due to sponsor termination of the atacicept 150 mg group were not imputed as flares in this analysis. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone greater than 20 mg daily or immunosuppressants); BILAG B: Disease less active than in "A", mild reversible problems requiring only symptomatic therapy such as antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), or prednisone less than 20 mg day; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved.
| Arm | Type | Description |
|---|---|---|
| Atacicept 75 mg | EXPERIMENTAL | - |
| Atacicept 150 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Atacicept 75 mg | DRUG | 75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. |
| Atacicept 150 mg | DRUG | 150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. |
| Placebo Comparator | OTHER | Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks. |
Inclusion Criteria: * Male or female 16 years of age or older * Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE * Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requi...