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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05757570
Other study ID # AIS-D04
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 3, 2023
Est. completion date November 2027

Study information

Verified date April 2024
Source Alpine Immune Sciences, Inc.
Contact Sarah Murphy
Phone 919-786-8898
Email sarah.murphy@iconplc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date November 2027
Est. primary completion date November 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Summary of Key Inclusion Criteria: 1. Indication-specific Criteria 1. 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 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 =9 g/dL - At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >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 =9 g/dL - At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >ULN (iii) lactate dehydrogenase>ULN - 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 Summary of 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, other marketed biologic therapeutics: <8 weeks 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

Study Design


Intervention

Drug:
povetacicept
Administered by subcutaneous injection every 4 weeks

Locations

Country Name City State
Australia Investigational Site (410) Box Hill Victoria
Australia Investigational Site (517) Douglas Queensland
Australia Investigational Site (413) Liverpool New South Wales
Australia Investigational Site (407) West Perth Western Australia
Australia Investigational Site (409) Westmead New South Wales
Canada Investigational Site (406) Greenfield Park Quebec
Canada Investigational Site (403) Hamilton Ontario
Turkey Investigational Site (415) Ankara
Turkey Investigational Site (416) Ankara
Turkey Investigational Site (418) Istanbul
United Kingdom Investigational Site (440) London
United States Investigational Site (422) Bronx New York
United States Investigational Site (414) Charlotte North Carolina
United States Investigational Site (435) Columbia Maryland
United States Investigational Site (419) Cooper City Florida
United States Investigational Site (402) Greenville North Carolina
United States Investigational Site (219) Iowa City Iowa
United States Investigational site (405) Lake Success New York
United States Investigational Site (230) Los Angeles California
United States Investigational Site (425) Miami Florida
United States Investigational Site (423) New Hyde Park New York
United States Investigational Site (404) New York New York
United States Investigational Site (421) New York New York
United States Investigational Site (420) Port Jefferson Station New York
United States Investigational Site (411) Seattle Washington
United States Investigational Site (401) Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Alpine Immune Sciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Type, incidence, severity, and seriousness of AEs Study Day 1 through 30 days after last dose of study drug
See also
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