Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
NCT05248646 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530
Last updated 2026-02-20
Summary
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
Conditions
- Immunoglobulin A Nephropathy
Interventions
- DRUG
-
Sibeprenlimab 400 mg
Solution for Injection
- DRUG
-
Placebo s.c. q 4 weeks
Sponsors & Collaborators
-
Otsuka Pharmaceutical Development & Commercialization, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-15
- Primary Completion
- 2026-05-07
- Completion
- 2026-12-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- China
- Croatia
- Czechia
- France
- Germany
- Greece
- Hong Kong
- Hungary
- India
- Israel
- Italy
- Japan
- Malaysia
- Netherlands
- Philippines
- Poland
- Portugal
- Singapore
- South Korea
- Spain
- Sri Lanka
- Taiwan
- Thailand
- United Kingdom
- Vietnam
Study Locations
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