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

Phase 1

Recruiting

• Conditions: Immune Thrombocytopenia; Idiopathic Thrombocytopenic Purpura; Cold Agglutinin Disease; Warm Autoimmune Hemolytic Anemia
• Interventions: Drug: povetacicept

• Registration Number: NCT05757570
• Lead Sponsor: Alpine Immune Sciences, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-03-07
• Study Start: 2023-07-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Povetacicept 240mg	povetacicept	Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept
Part 2: Povetacicept Dose A	povetacicept	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

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability as Assessed by Adverse events (AEs) and Serious adverse events (SAEs)	Study Day 1 through 30 days after last dose of study drug

Trial Locations

Locations (44)

Investigational Site (442); 🇬🇧 Leeds, United Kingdom

Investigational Site (439); 🇬🇧 London, United Kingdom

Investigational Site (440); 🇬🇧 London, United Kingdom

Investigational Site (416); 🇹🇷 Ankara, Turkey

Investigational Site (418); 🇹🇷 Istanbul, Turkey

Investigational Site (519); 🇦🇺 Concord, Australia

Investigational Site (444); 🇨🇦 Toronto, Canada

Investigational Site (428); 🇮🇹 Milan, Italy

Investigational Site (429); 🇪🇸 Burgos, Spain

Investigational Site (441); 🇬🇧 London, United Kingdom

Investigational Site (230); 🇺🇸 Los Angeles, California, United States

Investigational Site (401); 🇺🇸 Washington, 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 (422); 🇺🇸 Bronx, New York, 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 (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 (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 (438); 🇩🇪 Essen, Germany

Investigational Site (432); 🇮🇹 Meldola, 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 (430); 🇪🇸 Madrid, Spain

Investigational Site (426); 🇪🇸 Murcia, Spain

Investigational Site (427); 🇪🇸 Seville, Spain

Investigational Site (415); 🇹🇷 Ankara, Turkey