Trials / Active Not Recruiting
Active Not RecruitingNCT05732402
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
An Open-Label, Multiple-Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Different Dose Levels of Povetacicept in Subjects With Autoantibody-Associated Glomerular Diseases (RUBY-3)
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Alpine Immune Sciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis - LN), or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52-week treatment extension period. Participants with IgAN and pMN may also receive povetacicept for an additional 52 weeks, if eligible.
Conditions
- Lupus Nephritis
- Immunoglobulin A Nephropathy
- Membranous Nephropathy
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Povetacicept | Administered by subcutaneous injection every 4 weeks |
Timeline
- Start date
- 2023-03-15
- Primary completion
- 2028-03-02
- Completion
- 2028-03-02
- First posted
- 2023-02-17
- Last updated
- 2025-10-14
Locations
30 sites across 4 countries: United States, Australia, Puerto Rico, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05732402. Inclusion in this directory is not an endorsement.