ACTIVE_NOT_RECRUITING

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

Conditions

Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Warm Autoimmune Hemolytic Anemia Cold Agglutinin Disease Autoimmune Cytopenia Immune Thrombocytopenic Purpura Hemolytic Anemia RUBY4 RUBY-4 Povetacicept ALPN-303 ALPN303 Autoimmune Hemolytic Anemia ITP wAIHA AIHA CAD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-03

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05757570

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Indication-specific Criteria 1. Immune Thrombocytopenia (ITP) * Documented persistent or chronic primary ITP of at least 12 weeks duration from diagnosis to Cycle 1 Day 1 * 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 ≤10 g/dL * At least one of the following: (i) haptoglobin \< lower limit of normal (LLN) (ii) indirect bilirubin \> upper limit of normal (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 ≤10 g/dL * Evidence of hemolysis during screening: (i) indirect bilirubin \>ULN and (ii) lactate dehydrogenase\>ULN or haptoglobin \<LLN * 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	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, any use after initiation of screening is exclusionary 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

Inclusion Criteria

Exclusion Criteria

1. Indication-specific Criteria
1. Immune Thrombocytopenia (ITP)
* Documented persistent or chronic primary ITP of at least 12 weeks duration from diagnosis to Cycle 1 Day 1
* 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 ≤10 g/dL
* At least one of the following: (i) haptoglobin \< lower limit of normal (LLN) (ii) indirect bilirubin \> upper limit of normal (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 ≤10 g/dL
* Evidence of hemolysis during screening: (i) indirect bilirubin \>ULN and (ii) lactate dehydrogenase\>ULN or haptoglobin \<LLN
* 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

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, any use after initiation of screening is exclusionary
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

Contacts and Locations

Study Locations (Sites)

Investigational Site (230)

Los Angeles, California, 90033

United States

Investigational Site (401)

Washington, District of Columbia, 20007

United States

Investigational Site (419)

Cooper City, Florida, 33024

United States

Investigational Site (425)

Miami, Florida, 33143

United States

Investigational Site (219)

Iowa City, Iowa, 52242

United States

Investigational Site (435)

Columbia, Maryland, 21044

United States

Investigational Site (422)

Bronx, New York, 10469

United States

Investigational site (405)

Lake Success, New York, 11042

United States

Investigational Site (423)

New Hyde Park, New York, 11040

United States

Investigational Site (421)

New York, New York, 10028

United States

Investigational Site (404)

New York, New York, 10065

United States

Investigational Site (420)

Shirley, New York, 11967

United States

Investigational Site (414)

Charlotte, North Carolina, 28204

United States

Investigational Site (402)

Greenville, North Carolina, 27834

United States

Investigational Site (411)

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Alpine Immune Sciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-03

Study Completion Date2026-07

Study Record Updates

Study Start Date2023-07-03

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Immune Thrombocytopenia
Warm Autoimmune Hemolytic Anemia
Cold Agglutinin Disease
Autoimmune Cytopenia
Idiopathic Thrombocytopenic Purpura
Immune Thrombocytopenic Purpura
Hemolytic Anemia
RUBY4
RUBY-4
Povetacicept
ALPN-303
ALPN303
Autoimmune Hemolytic Anemia
ITP
wAIHA
AIHA
CAD

Additional Relevant MeSH Terms

Immune Thrombocytopenia
Idiopathic Thrombocytopenic Purpura
Warm Autoimmune Hemolytic Anemia
Cold Agglutinin Disease