Trials / Active Not Recruiting
Active Not RecruitingNCT05757570
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias
Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (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 povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease 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 study treatment extension period.
Conditions
- Immune Thrombocytopenia
- Idiopathic Thrombocytopenic Purpura
- Warm Autoimmune Hemolytic Anemia
- Cold Agglutinin Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | povetacicept | Administered by subcutaneous injection every 4 weeks |
Timeline
- Start date
- 2023-07-03
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2023-03-07
- Last updated
- 2025-07-04
Locations
44 sites across 10 countries: United States, Australia, Austria, Canada, Germany, Italy, Norway, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05757570. Inclusion in this directory is not an endorsement.