An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias
NCT ID: NCT05757570
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2023-07-03
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Povetacicept 240mg
Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept
povetacicept
Administered by subcutaneous injection every 4 weeks
Part 2: Povetacicept Dose A
Based on the findings of Part 1, one or two dose levels may be assessed in Part 2; if two dose levels are assessed participants will be randomized to receive one of the two dose levels of Povetacicept
povetacicept
Administered by subcutaneous injection every 4 weeks
Interventions
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povetacicept
Administered by subcutaneous injection every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Alpine Immune Sciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigational Site (230)
Los Angeles, California, United States
Investigational Site (401)
Washington D.C., District of Columbia, United States
Investigational Site (419)
Cooper City, Florida, United States
Investigational Site (425)
Miami, Florida, United States
Investigational Site (219)
Iowa City, Iowa, United States
Investigational Site (435)
Columbia, Maryland, United States
Investigational site (405)
Lake Success, New York, United States
Investigational Site (423)
New Hyde Park, New York, United States
Investigational Site (421)
New York, New York, United States
Investigational Site (404)
New York, New York, United States
Investigational Site (420)
Shirley, New York, United States
Investigational Site (422)
The Bronx, New York, United States
Investigational Site (414)
Charlotte, North Carolina, United States
Investigational Site (402)
Greenville, North Carolina, United States
Investigational Site (411)
Seattle, Washington, United States
Investigational Site (410)
Box Hill, , Australia
Investigational Site (519)
Concord, , Australia
Investigational Site (517)
Douglas, , Australia
Investigational Site (413)
Liverpool, , Australia
Investigational Site (407)
West Perth, , Australia
Investigational Site (409)
Westmead, , Australia
Investigational Site (434)
Vienna, , Austria
Investigational Site (406)
Greenfield Park, , Canada
Investigational Site (403)
Hamilton, , Canada
Investigational Site (444)
Toronto, , Canada
Investigational Site (438)
Essen, , Germany
Investigational Site (432)
Meldola, , Italy
Investigational Site (428)
Milan, , Italy
Investigational Site (431)
Novara, , Italy
Investigational Site (443)
Trieste, , Italy
Investigational Site (433)
Grålum, , Norway
Investigational Site (437)
Trondheim, , Norway
Investigational Site (436)
Barcelona, , Spain
Investigational Site (429)
Burgos, , Spain
Investigational Site (430)
Madrid, , Spain
Investigational Site (426)
Murcia, , Spain
Investigational Site (427)
Seville, , Spain
Investigational Site (415)
Ankara, , Turkey (Türkiye)
Investigational Site (416)
Ankara, , Turkey (Türkiye)
Investigational Site (418)
Istanbul, , Turkey (Türkiye)
Investigational Site (442)
Leeds, , United Kingdom
Investigational Site (439)
London, , United Kingdom
Investigational Site (441)
London, , United Kingdom
Investigational Site (440)
London, , United Kingdom
Countries
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Other Identifiers
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2023-507067-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
AIS-D04
Identifier Type: -
Identifier Source: org_study_id
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