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)
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking of treatment allocation will be observed at least until Week 50.
Primary Purpose: Treatment
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)
Estimated Study Start Date: November 2021
Estimated Primary Completion Date: February 2023
Estimated Study Completion Date: February 2026
Arm:
- Experimental: LN Cohort: ALXN2050 Dose 1
- Experimental: LN Cohort: ALXN2050 Dose 2
- Placebo Comparator: LN Cohort: Placebo
- Experimental: IgAN Cohort: ALXN2050 Dose 1
- Experimental: IgAN Cohort: ALXN2050 Dose 2
- Placebo Comparator: IgAN Cohort: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 126 |
| Estimated Study start date | 01 November 2021 |
| Estimated Study Completion Date | 01 February 2026 |