CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 530 enrolled / 530 target
Drug / intervention
Sibeprenlimab 400 mg +1 moredrug
Likely dose
Sibeprenlimab 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05248646
NCT05248646Phase 3CompletedMonitor (10.3/mo)Completion was 1mo ago
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Feb 21, 2022·Updated Jun 3, 2026

In Brief

A Phase 3 clinical trial evaluating Sibeprenlimab 400 mg and Placebo for Immunoglobulin A Nephropathy. Completed, enrolled 530 participants across 308 sites in 31 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunoglobulin A Nephropathy
CountriesArgentina, 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, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedFeb 21, 2022
Enrollment StartMar 15, 2022
Primary CompletionMay 13, 2026
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 4.4 years ago

Arms & Interventions

Sibeprenlimab 400 mg s.c. q 4weeksactive_comparator

Drug: Sibeprenlimab 400 mg
Placeboplacebo_comparator

Drug: Placebo

Interventions

Sibeprenlimab 400 mgdrug

Solution for Injection

Placebodrug

Placebo s.c. q 4 weeks