A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema
Completed · Phase 1/Phase 2
Conditions studied: Hereditary Angioedema
In brief
The goal of this clinical trial is to test the drug navenibart in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of navenibart, and 2 other groups will get 2 doses of navenibart. Researchers will study the effects of navenibart in participants with HAE as this is the first time that the drug has been given to participants with HAE.
Key facts
- Study ID
- NCT05695248
- Run by
- Astria Therapeutics, Inc.
- People needed
- 29
- Starts
- 2023-02-21
- Expected to finish
- 2025-03-13
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented diagnosis of HAE (type I or II). The following must be met:
- a. Documented clinical history consistent with HAE (for example, subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
- Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
You may not qualify if…
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria.
- 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, within 7 days
- 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.
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
- Allergy & Asthma Clinic of Northwest Arkansas — Bentonville, Arkansas, United States
- Acuro Research, Inc. — 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
- Diagnostical 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 Králové, Czechia
- Charité Universitätsmedizin Berlin — Berlin, Germany
- Addenbrooke's Hospital — Cambridge, United Kingdom
- St. James's Hospital — Leeds, United Kingdom
Full record on ClinicalTrials.gov
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