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

Subscribe to Updates

Study Details

Medical Condition

Autoimmune Disease

Study Drug

Drug: Sibeprenlimab 400 mg
Drug: Placebo

Date

Mar 2022 - Dec 2026

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

For additional information regarding sites, contact 844-687-8522

New York, New York, United States, 10001

Status

N/A