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ACTIVE NOT RECRUITING

NCT05248646

PHASE3

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

530

Start Date

2022-03-15

Completion Date

2026-12-30

Last Updated

2026-02-20

Healthy Volunteers

Conditions

Immunoglobulin A Nephropathy

Interventions

DRUG

Sibeprenlimab 400 mg

Solution for Injection

DRUG

Placebo

Placebo s.c. q 4 weeks

Inclusion Criteria: * Male and female patients ≥ 18 years of age . * Biopsy-confirmed 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 and/or ARB 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 2021 CKD-EPI equation Exclusion Criteria: * 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 or MEST-C 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 protocol provides additional information about these and other inclusion and exclusion criteria.

Locations (308)

University of Alabama at Birmingham - Site #336

Birmingham, Alabama, United States

Mayo Clinic Arizona - Site #363

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences - Site #353

Little Rock, Arkansas, United States

Amicis Research Center - Site #341

Granada Hills, California, United States

University of CA San Diego - Site #351

La Jolla, California, United States

California Institute of Renal Research - Site #371

La Mesa, California, United States

Loma Linda University Health Care Clinical Trial Center Clinic - Site #372

Loma Linda, California, United States

Academic Medical Research Institute - Site #333

Los Angeles, California, United States

Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325

Los Angeles, California, United States

Stanford University - Site #370

Palo Alto, California, United States

North America Research Institute - Site #335

San Dimas, California, United States

University of California, San Francisco - Site #377

San Francisco, California, United States

Colorado Kidney Care PC - Site #330

Denver, Colorado, United States

Mayo Clinic in Florida - Site #321

Jacksonville, Florida, United States

South Florida Research Institute - Site #323

Lauderdale Lakes, Florida, United States

Columbus Research Group - Site #376

South Miami, Florida, United States

Fides Clinical Research North Atlanta Kidney Specialists - Site #373

Atlanta, Georgia, United States

Georgia Nephrology - Site #356

Lawrenceville, Georgia, United States

University of Iowa Hospitals & Clinics - Site #359

Iowa City, Iowa, United States

Kansas Nephrology Associates - Site #322

Wichita, Kansas, United States

Ochsner Medical Center - Site #334

New Orleans, Louisiana, United States

University of Maryland - Site #355

Baltimore, Maryland, United States

MGH Harvard - Site #369