Atacicept in Subjects With Active Lupus Nephritis (COMPASS)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Active Lupus Nephritis
Sponsor: Vera Therapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Renal Response as definedas UPCR ≤0.5 mg/mg, and eGFR ≥60 mL/min/1.73 m^2 or eGFR <60 mL/min/1.73 m^2 with no confirmed decrease from baseline of >20%
Time frame: Week 52
Secondary Endpoints
Renal Response with alternative success criteria
Time to UPCR of≤0.5 mg/mg
Renal Response at Week 104
Eligibility Criteria
Key Inclusion Criteria: 1. Male or Female at least 18 years of age at time of signing consent 2. Must have the ability to understand and sign and date a written informed consent form 3. Diagnosis of SLE 4. Biopsy- Proven Active LN 5. Requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN 6. Subject is willing to take oral MMF for the duration of the study Key Exclusion Criteria: 1. eGFR of ≤30 mL/min/1.73 m2. 2. Sclerosis in 50% of glomeruli on renal biopsy. 3. Evidence of rapidly progressive glomerulonephritis. 4. Currently requiring renal dialysis or expected to require dialysis during the study. 5. Serum igG \<7 g/L 6. Active infection or high infectious risk
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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