An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias

Immune Thrombocytopenia Clinical Trial

— RUBY-4  

Official title:

Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757570
• Other study ID #: AIS-D04
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 3, 2023
• Est. completion date: November 2027

Study information

• Verified date: April 2024
• Source: Alpine Immune Sciences, Inc.
• Contact: Sarah Murphy
• Phone: 919-786-8898
• Email: sarah.murphy[@]iconplc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Summary of Key Inclusion Criteria:

1. Indication-specific Criteria

1. Immune Thrombocytopenia (ITP)

• Documented primary ITP of at least 12 weeks duration
• History of failure or relapse to at least 2 treatment regimens for ITP
• History of exposure to a TPO-RA unless otherwise contraindicated or unavailable
• Documented history of platelets <30 × 10^9/L

2. Warm Autoimmune Hemolytic Anemia (wAIHA)

• Diagnosis of primary wAIHA of at least 12 weeks duration documented with a current or prior positive direct antiglobulin test (DAT) for anti-IgG (±C3d)
• Documented history of anemia with hemoglobin =9 g/dL
• At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >ULN (iii) lactate dehydrogenase>ULN
• History of failure or relapse to at least 2 treatment regimens for wAIHA

3. Cold Agglutinin Disease (CAD)

• Diagnosis of primary CAD of at least 12 weeks duration with all of the following: (i) chronic hemolysis (ii) polyspecific DAT positive (iii) monospecific DAT strongly positive for C3d (iv) cold agglutinin titer =64 at 4°C (v) IgG DAT =1+ (vi) no overt malignant disease
• Documented history of anemia with hemoglobin =9 g/dL
• At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >ULN (iii) lactate dehydrogenase>ULN
• History of failure or relapse to at least 1 treatment regimen for CAD

2. (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations

Summary of Key Exclusion Criteria:

1. Secondary AIHA, CAD, or ITP

2. Treatment with any of the following within the noted period prior to study entry

1. rituximab: <12 weeks

2. IVIg: <4 weeks

3. sutimlimab, other marketed biologic therapeutics: <8 weeks

4. plasmapheresis, plasma exchange, or double-filtration plasmapheresis: <8 weeks

5. transfusions with blood, blood products or other rescue medications: <2 weeks

6. splenectomy: <12 weeks

7. other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization or approved by the applicable national health authority: <5 half-lives and requires agreement of the Medical Monitor

3. Recent serious or ongoing infection; risk or history of serious infection

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Cold Agglutinin Disease
• Cytopenia
• Hemolysis
• Idiopathic Thrombocytopenic Purpura
• Immune Thrombocytopenia
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Warm Autoimmune Hemolytic Anemia

Intervention

Drug:
• povetacicept
Administered by subcutaneous injection every 4 weeks

Locations

Country	Name	City	State
Australia	Investigational Site (410)	Box Hill	Victoria
Australia	Investigational Site (517)	Douglas	Queensland
Australia	Investigational Site (413)	Liverpool	New South Wales
Australia	Investigational Site (407)	West Perth	Western Australia
Australia	Investigational Site (409)	Westmead	New South Wales
Canada	Investigational Site (406)	Greenfield Park	Quebec
Canada	Investigational Site (403)	Hamilton	Ontario
Turkey	Investigational Site (415)	Ankara
Turkey	Investigational Site (416)	Ankara
Turkey	Investigational Site (418)	Istanbul
United Kingdom	Investigational Site (440)	London
United States	Investigational Site (422)	Bronx	New York
United States	Investigational Site (414)	Charlotte	North Carolina
United States	Investigational Site (435)	Columbia	Maryland
United States	Investigational Site (419)	Cooper City	Florida
United States	Investigational Site (402)	Greenville	North Carolina
United States	Investigational Site (219)	Iowa City	Iowa
United States	Investigational site (405)	Lake Success	New York
United States	Investigational Site (230)	Los Angeles	California
United States	Investigational Site (425)	Miami	Florida
United States	Investigational Site (423)	New Hyde Park	New York
United States	Investigational Site (404)	New York	New York
United States	Investigational Site (421)	New York	New York
United States	Investigational Site (420)	Port Jefferson Station	New York
United States	Investigational Site (411)	Seattle	Washington
United States	Investigational Site (401)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Alpine Immune Sciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Type, incidence, severity, and seriousness of AEs	Study Day 1 through 30 days after last dose of study drug