Trials / Terminated
TerminatedNCT05097989
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
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)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALXN2050 | Oral tablets |
| DRUG | Placebo | Oral tablets |
Timeline
- Start date
- 2022-01-14
- Primary completion
- 2024-12-09
- Completion
- 2024-12-09
- First posted
- 2021-10-28
- Last updated
- 2025-10-15
- Results posted
- 2025-10-15
Locations
71 sites across 16 countries: United States, Argentina, Australia, Brazil, China, Germany, Israel, Italy, Mexico, Serbia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05097989. Inclusion in this directory is not an endorsement.