Long-term treatment with STAR-0215 for hereditary angioedema

A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients With Hereditary Angioedema (The ALPHA-SOLAR Trial)

This study is testing if a new treatment called STAR-0215 is safe and effective for people with hereditary angioedema over a long period of time.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Astria Therapeutics, Inc. (Industry-sponsored)
• Drugs / interventions: lanadelumab
• Locations: 20 sites (Birmingham, Alabama and 19 other locations)
• Trial ID: NCT06007677 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with a documented diagnosis of hereditary angioedema, either previously treated with STAR-0215 or new participants.

Not a fit: Patients who do not have a diagnosis of hereditary angioedema or those who have contraindications to STAR-0215 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of hereditary angioedema for patients.

How similar studies have performed: Other studies involving long-term treatments for hereditary angioedema have shown promise, indicating that this approach may be beneficial.

Eligibility criteria

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 this trial is running

Birmingham, Alabama and 19 other locations

• Alabama Allervie Clinical Research — Birmingham, Alabama, United States (Active_not_recruiting)
• Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD — Scottsdale, Arizona, United States (Active_not_recruiting)
• Little Rock Allergy & Asthma Clinical Research Center — Little Rock, Arkansas, United States (Active_not_recruiting)
• UC San Diego US HAEA Angioedema Center — San Diego, California, United States (Recruiting)
• Raffi Tachdjian MD, Inc — Santa Monica, California, United States (Active_not_recruiting)
• Allergy & Asthma Clinical Research — Walnut Creek, California, United States (Active_not_recruiting)
• Institute for Asthma and Allergy, PC — Chevy Chase, Maryland, United States (Active_not_recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Active_not_recruiting)
• Washington University School of Medicine — Saint Louis, Missouri, United States (Active_not_recruiting)
• Optimed Research — Columbus, Ohio, United States (Active_not_recruiting)
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Active_not_recruiting)
• AARA Research Center — Dallas, Texas, United States (Active_not_recruiting)
• Diagnostic Consultative Center Convex Ltd. — Sofia, Bulgaria (Recruiting)
• University of Alberta — Edmonton, Alberta, Canada (Active_not_recruiting)
• Ottawa Allergy Research Corporation — Ottawa, Ontario, Canada (Active_not_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)
• St. James's Hospital — Leeds, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Christopher Morabito, MD

Conditions Hereditary Angioedema; HAE; Angioedema; Long-term; Safety