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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Immune Thrombocytopenia
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Investigational Site (230), Los Angeles, California, United States, 90033

Washington

Investigational Site (401), Washington, District of Columbia, United States, 20007

Cooper City

Investigational Site (419), Cooper City, Florida, United States, 33024

Miami

Investigational Site (425), Miami, Florida, United States, 33143

Iowa City

Investigational Site (219), Iowa City, Iowa, United States, 52242

Columbia

Investigational Site (435), Columbia, Maryland, United States, 21044

Bronx

Investigational Site (422), Bronx, New York, United States, 10469

Lake Success

Investigational site (405), Lake Success, New York, United States, 11042

New Hyde Park

Investigational Site (423), New Hyde Park, New York, United States, 11040

New York

Investigational Site (421), New York, New York, United States, 10028

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alpine Immune Sciences, Inc.,

Allison Naumovski, STUDY_DIRECTOR, Alpine Immune Sciences, Inc.

Study Record Dates

2027-11