A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
- Registration Number
- NCT06007677
- Lead Sponsor
- Astria Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
- 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).
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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.
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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
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Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose Regimen 1 (Arm A): STAR-0215 STAR-0215 Participants will receive STAR-0215 every 3 months. Dose Regimen 2 (Arm B): STAR-0215 STAR-0215 Participants will receive STAR-0215 every 6 months. Dose Regimen 1 (Arm C): STAR-0215 STAR-0215 STAR-0215 will be administered as a subcutaneous injection. Dose Regimen 3 (Arm D): STAR-0215 STAR-0215 STAR-0215 will be administered as a subcutaneous injection.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Treatment-emergent Adverse Events Day 1 through study completion, an average of 6 years
- Secondary Outcome Measures
Name Time Method Change From Baseline in Monthly HAE Attack Rate Day 1, up to 5 years Severity of HAE Attacks Experienced by Participants Day 1 through up to 5 years All HAE attacks will be classified according to severity (mild, moderate, and severe).
Duration of HAE Attacks Day 1 through up to 5 years Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.
Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy Day 1 through up to 5 years Time to First HAE Attack After Each Dose Day 1 through up to 5 years Plasma Levels of Cleaved High-molecular-weight Kininogen Every 3 months for first 2 years, Every 6 months for next 3 years Blood samples will be collected on dosing days to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
Number of HAE Attack-free Days Day 1 through up to 5 years Number of Participants Experiencing Zero HAE Attacks Day 1 through up to 5 years Serum Concentration of STAR-0215 Every 3 months for first 2 years, Every 6 months for next 3 years Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215.
Number of Participants with Anti-drug Antibodies to STAR-0215 Every 3 months for first 2 years, Every 6 months for next 3 years Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum.
Trial Locations
- Locations (20)
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Diagnostic Consultative Center Convex Ltd.
🇧🇬Sofia, Bulgaria
Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
🇨🇿Hradec Králové, Czechia
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Alabama Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
🇺🇸Scottsdale, Arizona, United States
Little Rock Allergy & Asthma Clinical Research Center
🇺🇸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
🇺🇸Saint Louis, Missouri, United States
Optimed Research
🇺🇸Columbus, Ohio, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Ottawa Allergy Research Corporation
🇨🇦Ottawa, Ontario, Canada
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
St. James's Hospital
🇬🇧Leeds, United Kingdom