STAR-0215: STAR-0215 will be administered as a subcutaneous injection.
Study summary
The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
* 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 concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
* 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
Note: Other inclusion and exclusion criteria may apply.
Primary outcome measure(s)
Number of Participants Experiencing Treatment-emergent Adverse Events — Day 1 through study completion, an average of 6 years
Trial sites (22)
Facility
City
Region
Status
Allervie Clinical Research
Birmingham
Alabama
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale
Arizona
Acuro Research
Little Rock
Arkansas
UC San Diego US HAEA Angioedema Center
San Diego
California
Raffi Tachdjian MD, Inc
Santa Monica
California
Allergy & Asthma Clinical Research
Walnut Creek
California
Institute for Asthma and Allergy, PC
Chevy Chase
Maryland
Massachusetts General Hospital
Boston
Massachusetts
Washington University School of Medicine
St Louis
Missouri
Optimed Research
Columbus
Ohio
Penn State Health Milton S. Hershey Medical Center
Hershey
Pennsylvania
AARA Research Center
Dallas
Texas
Diagnostic Consultative Center Convex Ltd.
Sofia
Bulgaria
University of Alberta
Edmonton
Alberta
Ottawa Allergy Research Corporation
Ottawa
Ontario
Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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