To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q 4 weeks compared to placebo in patients with IgAN. The primary objective is to compare the relative change from baseline in the urinary protein to creatinine ratio (uPCR) in 24-hour urine collections, after 9 months of treatment. The key secondary objective is to compare the annualized rate of change from baseline (slope) of estimated glomerular filtration rate (eGFR) after approximately 24 months of treatment. There will be one main cohort comprised of approximately 450 subjects with source-verified biopsy-confirmed IgAN and eGFR ≥ 30 mL/min/1.73 m\^2. An additional exploratory cohort will be comprised of up to 20 subjects with source-verified biopsy confirmed IgAN and eGFR of 20 to \< 29 mL/min/1.73 m\^2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
530
Solution for Injection
Placebo s.c. q 4 weeks
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
Time frame: At 9 months
Annualized rate of change (slope) of eGFR
Time frame: Over 24 months
Mean change of eGFR from baseline
Time frame: Over 24 months
Progression to composite kidney failure (CKF)
Time frame: Time from the randomization date to first occurrence of CKF
Percentage of participants with Progression to CKF
Time frame: Over 24 months
Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations
Time frame: Up to Week 112
Number of Participants With Adverse Events (AEs)
Time frame: Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Laboratory Tests
Time frame: Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Vital Signs
Time frame: Up to Week 112
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Time frame: Up to Week 112
Number of Participants With Injection Site Reactions
Time frame: Up to Week 112
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University of Alabama at Birmingham - Site #336
Birmingham, Alabama, United States
Mayo Clinic Arizona - Site #363
Phoenix, Arizona, United States
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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
...and 298 more locations
Evaluation of serum ADA
Time frame: Up to Week 112