A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
NCT ID: NCT06007677
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2023-09-26
2031-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Regimen 1 (Arm A): STAR-0215
Participants will receive STAR-0215 every 3 months.
STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Dose Regimen 2 (Arm B): STAR-0215
Participants will receive STAR-0215 every 6 months.
STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Dose Regimen 1 (Arm C): STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Dose Regimen 3 (Arm D): STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Interventions
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STAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* Completed STAR-0215-201 (follow up through 6 months after their last dose);
* Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks;
* Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor); or
* Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor).
* Open to participants who are STAR-0215 naïve and were not enrolled in STAR-0215-201 (NCT05695248), have a documented diagnosis of HAE (Type 1 or Type 2).
Exclusion Criteria
* Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening
* Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
* Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
* lanadelumab within 90 days
* berotralstat within 21 days
* all other prophylactic therapies, discuss with the Medical Monitor
18 Years
ALL
No
Sponsors
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Astria Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Allervie Clinical Research
Birmingham, Alabama, United States
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona, United States
Acuro Research
Little Rock, Arkansas, United States
UC San Diego US HAEA Angioedema Center
San Diego, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Optimed Research
Columbus, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
Diagnostic Consultative Center Convex Ltd.
Sofia, , Bulgaria
University of Alberta
Edmonton, Alberta, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
Hradec Králové, , Czechia
Charité Universitätsmedizin Berlin
Berlin, , Germany
Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Addenbrooke's Hospital
Cambridge, , United Kingdom
St. James's Hospital
Leeds, , United Kingdom
Countries
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Other Identifiers
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2023-506540-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
STAR-0215-202
Identifier Type: -
Identifier Source: org_study_id
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