Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)

Study Identifier:

417-201-00007

ClinicalTrials.gov Identifier:

NCT05248646

EudraCT Identifier:

N/A

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

N/A

Will Be Recruiting

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Study Details

Medical Condition

Autoimmune Disease

Study Drug

Drug: Sibeprenlimab 400 mg
Drug: Placebo

Date

Mar 2022 - Dec 2026

Phase 1/2

Phase 2/3

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 18+ years

Requirements Information

Protocol Summary

This is a phase 3 study to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

Study Locations

Location

Status

Location

University of Alabama at Birmingham - Site #336

Birmingham, Alabama, United States, 35233

Status

N/A

Location

Mayo Clinic Arizona - Site #363

Phoenix, Arizona, United States, 85054

Status

N/A

Location

University of Arkansas for Medical Sciences - Site #353

Little Rock, Arkansas, United States, 72205

Status

N/A

Location

Amicis Research Center - Site #341

Granada Hills, California, United States, 91344

Status

N/A

Location

University of CA San Diego - Site #351

La Jolla, California, United States, 92037

Status

N/A

Location

California Institute of Renal Research - Site #371

La Mesa, California, United States, 91942

Status

N/A