Study of ALXN2050 in proliferative lupus nephritis (LN) and immunoglobulin A nephropathy (IgAN)
Study of ALXN2050 in proliferative lupus nephritis (LN) and immunoglobulin A nephropathy (IgAN)
ClinicalTrials.gov ID: NCT05097989
Sponsor: Alexion Pharmaceuticals, Inc.
Information provided by: Alexion Pharmaceuticals, Inc. (Responsible Party)
Last Update Posted: 2024-07-19
Brief Summary:
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤ 75 years of age) with either LN or IgAN. The study will consist of an up to 6-week Screening Period, a 26-week blinded Initial Evaluation Period, a 24-week blinded Extended Treatment Period, and an Open-label Extension (OLE) Period of up to 2 years.
Safety will be monitored throughout the study.
Official Title:
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Intervention / Treatment:
- Drug: ALXN2050
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-01-14
|
| Primary Completion (Estimated) |
2026-06-30
|
| Study Completion (Estimated) |
2026-06-30
|
| Enrollment (Estimated) | 70 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
ALXN2050-NEPH-201
|