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

NCT05248659 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-05

No results posted yet for this study

Summary

To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN

Conditions

  • Immunoglobulin A Nephropathy

Interventions

DRUG

Sibeprenlimab 400 mg s.c. Q4weeks

Sibeprenlimab 400 mg s.c. q 4 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2028-12-28
Completion
2029-12-31
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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05248659 on ClinicalTrials.gov