RUBY-4: An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias

Sponsor

Alpine Immune Sciences, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05757570

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this clinical study is to evaluate povetacicept (ALPN-303) 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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Warm Autoimmune Hemolytic Anemia Cold Agglutinin Disease	Drug: povetacicept	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1b Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2027

Anticipated Study Completion Date :

Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: povetacicept 240mg	Drug: povetacicept Administered by subcutaneous injection every 4 weeks Other Names: ALPN-303

Arm

Intervention/Treatment

Experimental: povetacicept 240mg

Drug: povetacicept

Administered by subcutaneous injection every 4 weeks

Other Names:

ALPN-303

Outcome Measures

Primary Outcome Measures

Adverse Events [Study Day 1 through 30 days after last dose of study drug]
Type, incidence, severity, and seriousness of AEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Summary of Key Inclusion Criteria:

Indication-specific Criteria
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

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

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 2 treatment regimens for CAD

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

Summary of Key Exclusion Criteria:

Secondary AIHA, CAD, or ITP
Treatment with any of the following within the noted period prior to study entry
rituximab: 12 weeks
IVIG, sutimlimab, other marketed biologic therapeutics: 8 weeks
plasmapheresis, plasma exchange, or double-filtration plasmapheresis: 8 weeks
transfusions with blood, blood products or other rescue medications: 2 weeks
splenectomy: 12 weeks
other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization by the applicable national health authority: 5 half-lives and requires agreement of the Medical Monitor
Recent serious or ongoing infection; risk or history of serious infection