Jade Biosciences, Inc.
This Phase 3 study will evaluate the safety and efficacy of JADE101 compared with placebo in adults with immunoglobulin A nephropathy (IgAN). The results will contribute to the overall clinical characterization of JADE101 in this patient population.
Inclusion Criteria: 1. Adult participants with biopsy-confirmed primary IgAN. 2. UPCR ≥0.75 g/g or 24-hour protein excretion ≥1 g/day, as measured from an adequately collected 24-hour urine sample. 3. eGFR ≥30 mL/min/1.73 m². 4. Stable and maximally tolerated doses of ACEi and/or ARB according to standard of care and applicable guidelines for at least 12 weeks prior to the initial screening visit. Exclusion Criteria: 1. Secondary forms of IgAN, or ongoing IgA vasculitis (Henoch-Schönlein purpura) with systemic involvement requiring immunosuppressive treatment. 2. Known or clinically suspect…
JADE101 is supplied as sterile solution to be administered by SC injection.
Placebo is supplied as sterile solution to be administered by SC injection.
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