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

Last updated: January 24, 2025
Sponsor: Alpine Immune Sciences, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lupus

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Anemia

Treatment

povetacicept

Clinical Study ID

NCT05757570
AIS-D04
2023-507067-19-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Indication-specific Criteria

  2. Immune Thrombocytopenia (ITP)

  • Documented persistent or chronic primary ITP of at least 12 weeks durationfrom 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 orunavailable
  • Documented history of platelets <30 × 10^9/L
  1. Warm Autoimmune Hemolytic Anemia (wAIHA)
  • Diagnosis of primary wAIHA of at least 12 weeks duration documented with acurrent 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) lactatedehydrogenase>ULN
  • History of failure or relapse to at least 2 treatment regimens for wAIHA
  1. Cold Agglutinin Disease (CAD)
  • Diagnosis of primary CAD of at least 12 weeks duration with all of thefollowing: (i) chronic hemolysis (ii) polyspecific DAT positive (iii)monospecific DAT strongly positive for C3d (iv) cold agglutinin titer ≥64at 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
  1. (All indications) If receiving protocol-specified standard-of-care medications,doses must be stable for protocol-specified durations

Exclusion

Key Exclusion Criteria:

  1. Secondary AIHA, CAD, or ITP

  2. Treatment with any of the following within the noted period prior to study entry

  3. rituximab: <12 weeks

  4. IVIg: <4 weeks

  5. sutimlimab, any use after initiation of screening is exclusionary

  6. plasmapheresis, plasma exchange, or double-filtration plasmapheresis: <8 weeks

  7. transfusions with blood, blood products or other rescue medications: <2 weeks

  8. splenectomy: <12 weeks

  9. other immunomodulatory or investigational agents, except for investigationalagents for COVID-19 that have been granted emergency use authorization orapproved by the applicable national health authority: <5 half-lives andrequires agreement of the Medical Monitor

  10. Recent serious or ongoing infection; risk or history of serious infection

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 126
Treatment Group(s): 1
Primary Treatment: povetacicept
Phase: 1/2
Study Start date:
July 03, 2023
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Investigational Site (410)

    Box Hill, 3128
    Australia

    Active - Recruiting

  • Investigational Site (519)

    Concord, 2139
    Australia

    Active - Recruiting

  • Investigational Site (517)

    Douglas, 4814
    Australia

    Completed

  • Investigational Site (413)

    Liverpool, 2170
    Australia

    Active - Recruiting

  • Investigational Site (407)

    West Perth, 6005
    Australia

    Active - Recruiting

  • Investigational Site (409)

    Westmead, 2145
    Australia

    Active - Recruiting

  • Investigational Site (434)

    Vienna, 1090
    Austria

    Active - Recruiting

  • Investigational Site (406)

    Greenfield Park, J4V2H1
    Canada

    Active - Recruiting

  • Investigational Site (403)

    Hamilton, L8S 4K1
    Canada

    Active - Recruiting

  • Investigational Site (444)

    Toronto, M5B 1W8
    Canada

    Active - Recruiting

  • Investigational Site (438)

    Essen, 45147
    Germany

    Active - Recruiting

  • Investigational Site (432)

    Meldola, 47014
    Italy

    Active - Recruiting

  • Investigational Site (428)

    Milan, 20122
    Italy

    Active - Recruiting

  • Investigational Site (431)

    Novara, 28100
    Italy

    Site Not Available

  • Investigational Site (443)

    Trieste, 34128
    Italy

    Site Not Available

  • Investigational Site (433)

    Grålum, 1714
    Norway

    Active - Recruiting

  • Investigational Site (437)

    Trondheim, 7030
    Norway

    Active - Recruiting

  • Investigational Site (436)

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Investigational Site (429)

    Burgos, 9006
    Spain

    Active - Recruiting

  • Investigational Site (430)

    Madrid, 28007
    Spain

    Active - Recruiting

  • Investigational Site (425)

    Murcia, 30008
    Spain

    Active - Recruiting

  • Investigational Site (426)

    Murcia, 30008
    Spain

    Active - Recruiting

  • Investigational Site (427)

    Seville, 41013
    Spain

    Active - Recruiting

  • Investigational Site (415)

    Ankara, 06200
    Turkey

    Completed

  • Investigational Site (416)

    Ankara, 06800
    Turkey

    Completed

  • Investigational Site (418)

    Istanbul, 34718
    Turkey

    Completed

  • Investigational Site (442)

    Leeds, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Investigational Site (439)

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • Investigational Site (440)

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Investigational Site (441)

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Investigational Site (230)

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Investigational Site (401)

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Investigational Site (419)

    Cooper City, Florida 33024
    United States

    Active - Recruiting

  • Investigational Site (425)

    Miami, Florida 33143
    United States

    Active - Recruiting

  • Investigational Site (219)

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Investigational Site (435)

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Investigational Site (422)

    Bronx, New York 10469
    United States

    Active - Recruiting

  • Investigational site (405)

    Lake Success, New York 11042
    United States

    Active - Recruiting

  • Investigational Site (423)

    New Hyde Park, New York 11040
    United States

    Active - Recruiting

  • Investigational Site (404)

    New York, New York 10065
    United States

    Active - Recruiting

  • Investigational Site (421)

    New York, New York 10028
    United States

    Active - Recruiting

  • Investigational Site (420)

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Investigational Site (420)

    Shirley, New York 11967
    United States

    Active - Recruiting

  • Investigational Site (414)

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Investigational Site (402)

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Investigational Site (411)

    Seattle, Washington 98109
    United States

    Active - Recruiting

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