NCT05797610

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.

Conditions

• Primary IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Sefaxersen (RO7434656)	Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
DRUG	Placebo	Matching placebo will be administered as SC injection per schedule as specified.

Timeline

• Start date: 2023-08-08
• Primary completion: 2026-08-31
• Completion: 2029-03-31
• First posted: 2023-04-04
• Last updated: 2026-04-13

Locations

202 sites across 21 countries: United States, Argentina, Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Italy, Japan, Malaysia, Mexico, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study