Atacicept in subjects with IgA nephropathy (ORIGIN 3)
Atacicept in subjects with IgA nephropathy (ORIGIN 3)
ClinicalTrials.gov ID: NCT04716231
Sponsor: Vera Therapeutics, Inc.
Information provided by: Vera Therapeutics, Inc. (Responsible Party)
Last Update Posted: 2023-11-29
Brief 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 (active, no longer recruiting) and the addition of a separate pivotal Phase 3 study (active, recruiting).
After the completion of the primary results for the Ph 2b dose ranging study, the pivotal study (active, recruiting) 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.
Official Title:
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)
Intervention / Treatment:
- Biological: Atacicept
- Other: Placebo to match Atacicept
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-05-23
|
| Primary Completion (Estimated) |
2025-05-01
|
| Study Completion (Estimated) |
2028-07-01
|
| Enrollment (Estimated) | 376 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
VT-001-0050
|