The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects With Lupus Nephritis in Combination With Mycophenolate Mofetil Therapy.
Sponsor: EMD Serono + ZymoGenetics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
Time frame: At Week 52
Secondary Endpoints
Percentage of Participants With Normalization of Renal Function
Number of Participants With New Lupus Flares
Eligibility Criteria
Inclusion Criteria: * Diagnosis of systemic lupus erythematosus (SLE) satisfying at least 4 out of the 11 American College of Rheumatology (ACR) criteria (Appendix B) * Renal biopsy performed consistent with active International Society of Nephrology/Renal Pathology Society (ISN/PRS) class III or IV lupus nephritis Exclusion Criteria: * Estimated glomerular filtration rate (GFR) less than or equal to (\<=) 30 milliliter per minute (mL/min) per 1.73 square meter (m\^2) * Active central nervous system SLE deemed to be severe or progressive and/or associated with significant cognitive impairment * Any treatment with MMF, azathioprine, or cyclophosphamide within the last 6 months, or known hypersensitivity to MMF or atacicept. * Any prior treatment with abatacept, rituximab, belimumab, or other B cell modulating agents.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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