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

February 15, 2024 updated by: Alpine Immune Sciences, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Investigational Site (413)
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Investigational Site (409)
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Recruiting
        • Investigational Site (517)
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Investigational Site (410)
    • Western Australia
      • West Perth, Western Australia, Australia, 6005
        • Recruiting
        • Investigational Site (407)
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Recruiting
        • Investigational Site (403)
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V2H1
        • Recruiting
        • Investigational Site (406)
  • Turkey
      • Ankara, Turkey, 06200
        • Recruiting
        • Investigational Site (415)
      • Ankara, Turkey, 06800
        • Recruiting
        • Investigational Site (416)
      • Istanbul, Turkey, 34718
        • Recruiting
        • Investigational Site (418)
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Investigational Site (230)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Investigational Site (401)
    • Florida
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • Investigational Site (419)
      • Miami, Florida, United States, 33143
        • Recruiting
        • Investigational Site (425)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Investigational Site (219)
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • Investigational Site (435)
    • New York
      • Bronx, New York, United States, 10469
        • Recruiting
        • Investigational Site (422)
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Investigational site (405)
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Investigational Site (423)
      • New York, New York, United States, 10065
        • Recruiting
        • Investigational Site (404)
      • New York, New York, United States, 10028
        • Recruiting
        • Investigational Site (421)
      • Port Jefferson Station, New York, United States, 11776
        • Recruiting
        • Investigational Site (420)
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Investigational Site (414)
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Investigational Site (402)
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Investigational Site (411)

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: povetacicept 240mg
Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Names:
  • ALPN-303
Experimental: Part 2: povetacicept Dose A
Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Names:
  • ALPN-303
Experimental: Part 2: povetacicept Dose B
Drug: povetacicept
Administered by subcutaneous injection every 4 weeks
Other Names:
  • ALPN-303

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Study Day 1 through 30 days after last dose of study drug
Type, incidence, severity, and seriousness of AEs
Study Day 1 through 30 days after last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpine Immune Sciences, Inc.

Investigators

  • Study Director: Allison Naumovski, 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 Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIS-D04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immune Thrombocytopenia

Clinical Trials on povetacicept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe