Long-term treatment with STAR-0215 for hereditary angioedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to gather information on the long-term safety and clinical effectiveness of STAR-0215 in individuals with hereditary angioedema (HAE). Participants will receive repeated doses of STAR-0215 over a period of up to five years. The study is designed to include both participants who have previously been part of another related trial and those who are new to STAR-0215 but have a documented diagnosis of HAE. The focus is on monitoring the safety and clinical activity of the treatment throughout the study duration.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC San Diego US HAEA Angioedema Center
  San Diego, California, United States Recruiting
• Diagnostic Consultative Center Convex Ltd.
  Sofia, Bulgaria Recruiting
• Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
  Hradec Králové, Czechia Recruiting
• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• Universitätsklinikum Frankfurt
  Frankfurt, Germany Recruiting
• Addenbrooke's Hospital
  Cambridge, United Kingdom Recruiting

Study contacts

• Study coordinator: Christopher Morabito, MD
• Email: cmorabito@astriatx.com
• Phone: 1-617-349-1971

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sebetralstat before procedures for hereditary angioedema

  This trial tests whether a single 600 mg dose of sebetralstat can safely and effectively prevent angioedema attacks around planned procedures in people aged 12 and older with hereditary angioedema.

  Recruiting Phase 4 KalVista Pharmaceuticals, Ltd. · Colorado Springs, Colorado · NCT07654829

• STOP-HAE: ADX-324 for hereditary angioedema

  This trial tests whether ADX-324 can reduce HAE attacks in adults with Type 1 or Type 2 hereditary angioedema.

  Recruiting at 52 sites Phase 3 ADARx Pharmaceuticals, Inc. · Litchfield Park, Arizona and 69 other locations · NCT06960213

• Registry for Rare Diseases

  This study is creating a detailed registry to collect information on rare diseases like amyloidosis and sarcoidosis to help improve how they are diagnosed and treated.

  Recruiting Hospital Italiano de Buenos Aires · Buenos Aires, Buenos Aires · NCT06573723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.