Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Purpose
The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.
Condition
- Immunoglobulin A Nephropathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosed IgAN, with biopsy confirmation - 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g - Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2 - Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification
Exclusion Criteria
- Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol - Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Povetacicept |
Participants will be randomized to receive Povetacicept. |
|
|
Placebo Comparator Placebo |
Participants will be randomized to receive placebo matched to Povetacicept. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06564142
- Status
- Active, not recruiting
- Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex