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Can a new drug calm the immune System's attack on blood cells?

NCT ID NCT05757570

Disease control Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This study is testing an experimental drug called povetacicept in adults with autoimmune cytopenias — conditions where the immune system mistakenly destroys blood cells, leading to low platelet counts (immune thrombocytopenia) or anemia (autoimmune hemolytic anemia and cold agglutinin disease). Participants receive a shot of povetacicept every 4 weeks for 6 months, with an optional 6-month extension. The goal is to see if the drug is safe and may help control these diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental drug called povetacicept (also known as ALPN-303), given as a shot under the skin every 4 weeks
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat autoimmune cytopenias.
What could go wrong
This is an early-phase trial with only 30 participants, so the drug may not prove safe or effective. Possible side effects include injection-site reactions and immune suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Started

Jul 2023

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Indication-specific 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 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, 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 Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia autoimmune hemolytic anemia, warm type autoimmune thrombocytopenic purpura cold agglutinin disease hemolytic anemia Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cold agglutinin disease Idiopathic thrombocytopenic purpura Immune thrombocytopenia Warm autoimmune hemolytic anemia

Contacts and locations

Locations

  • Investigational Site (219)

    Iowa City, Iowa, 52242, United States

  • Investigational Site (230)

    Los Angeles, California, 90033, United States

  • Investigational Site (401)

    Washington D.C., District of Columbia, 20007, United States

  • Investigational Site (402)

    Greenville, North Carolina, 27834, United States

  • Investigational Site (403)

    Hamilton, L8S 4K1, Canada

  • Investigational Site (404)

    New York, New York, 10065, United States

  • Investigational Site (406)

    Greenfield Park, J4V2H1, Canada

  • Investigational Site (407)

    West Perth, 6005, Australia

  • Investigational Site (409)

    Westmead, 2145, Australia

  • Investigational Site (410)

    Box Hill, 3128, Australia

  • Investigational Site (411)

    Seattle, Washington, 98109, United States

  • Investigational Site (413)

    Liverpool, 2170, Australia

  • Investigational Site (414)

    Charlotte, North Carolina, 28204, United States

  • Investigational Site (415)

    Ankara, 06200, Turkey (Türkiye)

  • Investigational Site (416)

    Ankara, 06800, Turkey (Türkiye)

  • Investigational Site (418)

    Istanbul, 34718, Turkey (Türkiye)

  • Investigational Site (419)

    Cooper City, Florida, 33024, United States

  • Investigational Site (420)

    Shirley, New York, 11967, United States

  • Investigational Site (421)

    New York, New York, 10028, United States

  • Investigational Site (422)

    The Bronx, New York, 10469, United States

  • Investigational Site (423)

    New Hyde Park, New York, 11040, United States

  • Investigational Site (425)

    Miami, Florida, 33143, United States

  • Investigational Site (426)

    Murcia, 30008, Spain

  • Investigational Site (427)

    Seville, 41013, Spain

  • Investigational Site (428)

    Milan, 20122, Italy

  • Investigational Site (429)

    Burgos, 9006, Spain

  • Investigational Site (430)

    Madrid, 28007, Spain

  • Investigational Site (431)

    Novara, 28100, Italy

  • Investigational Site (432)

    Meldola, 47014, Italy

  • Investigational Site (433)

    Grålum, 1714, Norway

  • Investigational Site (434)

    Vienna, 1090, Austria

  • Investigational Site (435)

    Columbia, Maryland, 21044, United States

  • Investigational Site (436)

    Barcelona, 08003, Spain

  • Investigational Site (437)

    Trondheim, 7030, Norway

  • Investigational Site (438)

    Essen, 45147, Germany

  • Investigational Site (439)

    London, E1 1BB, United Kingdom

  • Investigational Site (440)

    London, W12 0HS, United Kingdom

  • Investigational Site (441)

    London, SE1 9RT, United Kingdom

  • Investigational Site (442)

    Leeds, SE1 9RT, United Kingdom

  • Investigational Site (443)

    Trieste, 34128, Italy

  • Investigational Site (444)

    Toronto, M5B 1W8, Canada

  • Investigational Site (517)

    Douglas, 4814, Australia

  • Investigational Site (519)

    Concord, 2139, Australia

  • Investigational site (405)

    Lake Success, New York, 11042, United States

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