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

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ClinicalTrials.gov Identifier: NCT05757570
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : February 16, 2024
Sponsor:
Information provided by (Responsible Party):
Alpine Immune Sciences, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura Warm Autoimmune Hemolytic Anemia Cold Agglutinin Disease Drug: povetacicept Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: If 2 doses are used in Part 2, it will be randomized, parallel group assignment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)
Actual Study Start Date : July 3, 2023
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2027


Arm Intervention/treatment
Experimental: Part 1: povetacicept 240mg Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Name: ALPN-303

Experimental: Part 2: povetacicept Dose A Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Name: ALPN-303

Experimental: Part 2: povetacicept Dose B Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Name: ALPN-303




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Study Day 1 through 30 days after last dose of study drug ]
    Type, incidence, severity, and seriousness of AEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757570


Contacts
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Contact: Sarah Murphy 919-786-8898 sarah.murphy@iconplc.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Alpine Immune Sciences, Inc.
Investigators
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Study Director: Allison Naumovski Alpine Immune Sciences, Inc.
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Responsible Party: Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier: NCT05757570    
Other Study ID Numbers: AIS-D04
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpine Immune Sciences, Inc.:
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:
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Anemia
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases