A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
Running, not enrolling · Phase 2
Conditions studied: Hereditary Angioedema
In brief
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.
Key facts
- Study ID
- NCT06007677
- Run by
- Astria Therapeutics, Inc.
- People needed
- 56
- Starts
- 2023-09-26
- Expected to finish
- 2031-03-01
- Last updated by the study team
- 2025-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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