NCT04716231

Atacicept in Subjects With IgA Nephropathy

A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IgAN)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Vera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 Study with Atacicept in Subjects With IgA Nephropathy (ORIGIN 3)

Detailed description

This is a multi-part study comprising of the original Phase 2b study and the addition of a separate pivotal Phase 3 study. After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study will evaluate the efficacy and safety of atacicept compared to placebo in reducing proteinuria in subjects with IgAN and persistent proteinuria despite being on a maximally tolerated dose (MTD) of a RASi. Safety, eGFR, serum immunoglobulins and Gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 104wk double-blind treatment period, followed by a 52wk open-label treatment period and a 26wk safety follow-up period. The UPCR primary endpoint will be assessed after the first 200 patients are randomized.

Conditions

• IgA Nephropathy
• Berger Disease

Interventions

Type	Name	Description
BIOLOGICAL	Atacicept	Once weekly subcutaneous (SC) injections by prefilled syringe
OTHER	Placebo to match Atacicept	Once weekly subcutaneous (SC) injections by prefilled syringe

Timeline

• Start date: 2023-06-29
• Primary completion: 2025-05-15
• Completion: 2028-07-01
• First posted: 2021-01-20
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study