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Clinical Trials in the UK / NCT06007677
Active, not recruiting Phase 2

A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

NCT06007677 · tracked via the Priya Life Science UK tracker
Sponsor
Astria Therapeutics, Inc.
Phase
Phase 2
Started
2023-09-26
Last updated
2025-07-23

Condition(s) studied

Hereditary Angioedema

Investigational drug(s) / intervention(s)

STAR-0215

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)

Trial sites (22)

FacilityCityRegionStatus
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 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

More Astria Therapeutics, Inc. trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT06007677 on ClinicalTrials.gov ↗ ← All trials in the UK