Cold Agglutinin Disease Clinical Trial

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

Summary

The goal of this clinical study is to evaluate povetacicept (ALPN-303) 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.

View Eligibility Criteria

Eligibility Criteria

Summary of Key Inclusion Criteria:

Indication-specific Criteria

Immune Thrombocytopenia (ITP)

Documented primary ITP of at least 12 weeks duration
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 ≤9 g/dL
At least one of the following: (i) haptoglobin 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 ≤9 g/dL
At least one of the following: (i) haptoglobin ULN (iii) lactate dehydrogenase>ULN
History of failure or relapse to at least 1 treatment regimen for CAD
(All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations

Summary of Key Exclusion Criteria:

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
sutimlimab, other marketed biologic therapeutics: <8 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

Study is for people with:

Cold Agglutinin Disease

Phase:

Phase 1

Estimated Enrollment:

126

Study ID:

NCT05757570

Recruitment Status:

Recruiting

Sponsor:

Alpine Immune Sciences, Inc.

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There are 25 Locations for this study

See Locations Near You

Investigational Site (230)
Los Angeles California, 90033, United States
Investigational Site (401)
Washington District of Columbia, 20007, United States
Investigational Site (419)
Cooper City Florida, 33024, United States
Investigational Site (425)
Miami Florida, 33143, United States
Investigational Site (219)
Iowa City Iowa, 52242, United States
Investigational Site (435)
Columbia Maryland, 21044, United States
Investigational Site (422)
Bronx New York, 10469, United States
Investigational site (405)
Lake Success New York, 11042, United States
Investigational Site (423)
New Hyde Park New York, 11040, United States
Investigational Site (421)
New York New York, 10028, United States
Investigational Site (404)
New York New York, 10065, United States
Investigational Site (420)
Port Jefferson Station New York, 11776, United States
Investigational Site (414)
Charlotte North Carolina, 28204, United States
Investigational Site (402)
Greenville North Carolina, 27834, United States
Investigational Site (411)
Seattle Washington, 98109, United States
Investigational Site (413)
Liverpool New South Wales, 2170, Australia
Investigational Site (409)
Westmead New South Wales, 2145, Australia
Investigational Site (517)
Douglas Queensland, 4814, Australia
Investigational Site (410)
Box Hill Victoria, 3128, Australia
Investigational Site (407)
West Perth Western Australia, 6005, Australia
Investigational Site (403)
Hamilton Ontario, L8S 4, Canada
Investigational Site (406)
Greenfield Park Quebec, J4V2H, Canada
Investigational Site (415)
Ankara , 06200, Turkey
Investigational Site (416)
Ankara , 06800, Turkey
Investigational Site (418)
Istanbul , 34718, Turkey

How clear is this clinincal trial information?

Study is for people with:

Cold Agglutinin Disease

Phase:

Phase 1

Estimated Enrollment:

126

Study ID:

NCT05757570

Recruitment Status:

Recruiting

Sponsor:


Alpine Immune Sciences, Inc.

How clear is this clinincal trial information?

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