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Evaluating povetacicept for autoimmune cytopenias

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

Phase1; Phase2 Interventional Alpine Immune Sciences, Inc. · NCT05757570

This study is testing a new medication called povetacicept to see if it can help adults with autoimmune cytopenias who haven't had success with other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment126 (estimated)
Ages18 Years and up
SexAll
SponsorAlpine Immune Sciences, Inc. Industry-sponsored
Drugs / interventionsrituximab, sutimlimab
Locations44 sites (Los Angeles, California and 43 other locations)
Trial IDNCT05757570 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety and potential benefits of povetacicept in adults suffering from autoimmune cytopenias, including immune thrombocytopenia, warm autoimmune hemolytic anemia, and cold agglutinin disease. Participants will receive povetacicept approximately every four weeks for six months, with an option for a six-month extension. The study focuses on individuals who have not responded to at least two prior treatment regimens for their conditions.

Who should consider this trial

Good fit: Ideal candidates include adults with documented chronic autoimmune cytopenias who have failed multiple treatment regimens.

Not a fit: Patients who have not been diagnosed with autoimmune cytopenias or those who have not failed previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with autoimmune cytopenias who have not responded to existing treatments.

How similar studies have performed: Other studies have shown promise in treating autoimmune cytopenias with novel therapies, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Immune ThrombocytopeniaIdiopathic Thrombocytopenic PurpuraWarm Autoimmune Hemolytic AnemiaCold Agglutinin DiseaseAutoimmune CytopeniaImmune Thrombocytopenic PurpuraHemolytic AnemiaRUBY4
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.