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

NCT05757570 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: AIS-D042023-507067-19-00
• Study Type: interventional
• Target: 30
• Locations: 9 countries
• Sites: 38

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.

Conditions

Immune Thrombocytopenia; Idiopathic Thrombocytopenic Purpura; Warm Autoimmune Hemolytic Anemia; Cold Agglutinin Disease

Keywords

Immune Thrombocytopenia; Warm Autoimmune Hemolytic Anemia; Cold Agglutinin Disease; Autoimmune Cytopenia; Idiopathic Thrombocytopenic Purpura; Immune Thrombocytopenic Purpura; Hemolytic Anemia; RUBY4; RUBY-4; Povetacicept; ALPN-303; ALPN303; Autoimmune Hemolytic Anemia; ITP; wAIHA; AIHA; CAD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Part 1: Povetacicept 240mg

EXPERIMENTAL

Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept

Drug: povetacicept

Part 2: Povetacicept Dose A

EXPERIMENTAL

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

Drug: povetacicept

Interventions

povetacicept DRUG

Administered by subcutaneous injection every 4 weeks

Also known as: ALPN-303

Part 1: Povetacicept 240mg; Part 2: Povetacicept Dose A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication-specific Criteria
• 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
• 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
• 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

You may not qualify if:

• Secondary AIHA, CAD, or ITP
• Treatment with any of the following within the noted period prior to study entry
• rituximab: \<12 weeks
• IVIg: \<4 weeks
• plasmapheresis, plasma exchange, or double-filtration plasmapheresis: \<8 weeks
• transfusions with blood, blood products or other rescue medications: \<2 weeks
• splenectomy: \<12 weeks
• 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
• Recent serious or ongoing infection; risk or history of serious infection

Sponsors & Collaborators

• Alpine Immune Sciences, Inc.: lead

Study Sites (44)

Investigational Site (230)

Los Angeles, California, 90033, United States

Location

Investigational Site (401)

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

Location

Investigational Site (419)

Cooper City, Florida, 33024, United States

Location

Investigational Site (425)

Miami, Florida, 33143, United States

Location

Investigational Site (219)

Iowa City, Iowa, 52242, United States

Location

Investigational Site (435)

Columbia, Maryland, 21044, United States

Location

Investigational site (405)

Lake Success, New York, 11042, United States

Location

Investigational Site (423)

New Hyde Park, New York, 11040, United States

Location

Investigational Site (421)

New York, New York, 10028, United States

Location

Investigational Site (404)

New York, New York, 10065, United States

Location

Investigational Site (420)

Shirley, New York, 11967, United States

Location

Investigational Site (422)

The Bronx, New York, 10469, United States

Location

Investigational Site (414)

Charlotte, North Carolina, 28204, United States

Location

Investigational Site (402)

Greenville, North Carolina, 27834, United States

Location

Investigational Site (411)

Seattle, Washington, 98109, United States

Location

Investigational Site (410)

Box Hill, 3128, Australia

Location

Investigational Site (519)

Concord, 2139, Australia

Location

Investigational Site (517)

Douglas, 4814, Australia

Location

Investigational Site (413)

Liverpool, 2170, Australia

Location

Investigational Site (407)

West Perth, 6005, Australia

Location

Investigational Site (409)

Westmead, 2145, Australia

Location

Investigational Site (434)

Vienna, 1090, Austria

Location

Investigational Site (406)

Greenfield Park, J4V2H1, Canada

Location

Investigational Site (403)

Hamilton, L8S 4K1, Canada

Location

Investigational Site (444)

Toronto, M5B 1W8, Canada

Location

Investigational Site (438)

Essen, 45147, Germany

Location

Investigational Site (432)

Meldola, 47014, Italy

Location

Investigational Site (428)

Milan, 20122, Italy

Location

Investigational Site (431)

Novara, 28100, Italy

Location

Investigational Site (443)

Trieste, 34128, Italy

Location

Investigational Site (433)

Grålum, 1714, Norway

Location

Investigational Site (437)

Trondheim, 7030, Norway

Location

Investigational Site (436)

Barcelona, 08003, Spain

Location

Investigational Site (429)

Burgos, 9006, Spain

Location

Investigational Site (430)

Madrid, 28007, Spain

Location

Investigational Site (426)

Murcia, 30008, Spain

Location

Investigational Site (427)

Seville, 41013, Spain

Location

Investigational Site (415)

Ankara, 06200, Turkey (Türkiye)

Location

Investigational Site (416)

Ankara, 06800, Turkey (Türkiye)

Location

Investigational Site (418)

Istanbul, 34718, Turkey (Türkiye)

Location

Investigational Site (442)

Leeds, SE1 9RT, United Kingdom

Location

Investigational Site (439)

London, E1 1BB, United Kingdom

Location

Investigational Site (441)

London, SE1 9RT, United Kingdom

Location

Investigational Site (440)

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Anemia, Hemolytic, Autoimmune; Anemia, Hemolytic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Anemia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: July 3, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

AU (1); GB (4); NO (2); TU (3); ES (5); US (15); IT (4); DE (1); CA (3)