Phase 3 study of anifrolumab in adult patients with active proliferative lupus nephritis (IRIS)
Phase 3 study of anifrolumab in adult patients with active proliferative lupus nephritis (IRIS)
ClinicalTrials.gov ID: NCT05138133
Sponsor: AstraZeneca
Information provided by: AstraZeneca (Responsible Party)
Last Update Posted: 2024-07-16
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis
Detailed Description:
This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.
Official Title:
A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
Intervention / Treatment:
- Drug: Anifrolumab
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-02-15
|
| Primary Completion (Estimated) |
2026-09-30
|
| Study Completion (Estimated) |
2028-07-07
|
| Enrollment (Estimated) | 346 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
D3466C00001
2021-002862-42 (EudraCT Number) |