A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects withImmunoglobulin A Nephropathy

Otsuka Pharmaceutical Development & Commercialization, Inc.0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

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•Male and female patients >18 years of age.
•Biopsy-confirmed IgA Nephropathy (IgAN). (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
•Stable and maximally tolerated dose of ACEI (Angiotensin-converting enzyme inhibitor) and/or ARB (Angiotensin receptor blocker) for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated >3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
•Screening urine protein/creatinine ratio (uPCR) >0.75 g/g or urine protein >1.0 g/day
•eGFR >30 mL/min/1.73 m2, (for the exploratory cohort* only: eGFR 20- <30 mL/min/1.73 m2), calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.
•*The Exploratory cohort is up to 20 subjects with IgAN and an eGFR of 20 to
•30 mL/min/1.73 m2. These subjects will also randomized with equal
•allocation (1:1) to sibeprenlimab or placebo in this cohort.

•Secondary forms of IgAN or IgA vasculitis.
•Coexisting chronic kidney disease other than IgAN.
•Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
•Kidney biopsy MEST (Mesangial cellularity, endocapillary proliferation, segmental sclerosis, tubular atrophy) or MEST-C (MEST-Crescents) score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort*.
•Nephrotic syndrome
•Serum IgG < 600 mg/dL at screening.
•Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
•Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
•Chronic infectious disease, or acute infectious disease at time of screening.
•Type 1 diabetes, or poorly controlled Type 2 diabetes
•Uncontrolled hypertension
•*The Exploratory cohort is up to 20 subjects with IgAN and an eGFR of 20 to
•30 mL/min/1.73 m2. These subjects will also randomized with equal
•allocation (1:1) to sibeprenlimab or placebo in this cohort.

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