Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
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.
Timeline
- Start
- 2022-01-14
- Primary completion
- 2024-12-09
- Completion
- 2024-12-09
Outcome
Missed primary endpoint
Stopped (Business): “Sponsor Decision.”
registry analysis (other test); IgAN Cohort: ALXN2050 180 mg vs IgAN Cohort: Placebo; p = 0.2422; Percentage Difference -17.7 (90% CI -37.5 to 8.3); ANCOVA NCT05097989 ↗
registry analysis (other test); LN Cohort: ALXN2050 180 mg vs LN Cohort: Placebo; p = 0.8701; Percentage Difference -6.0 (90% CI -49.3 to 74.4); ANCOVA NCT05097989 ↗
Publications
- Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
- Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vemircopan | Small molecule | 120 mg | Oral |
| Subject | Vemircopan | Small molecule | 180 mg | Oral |