A Study of STAR-0215 in Participants With Hereditary Angioedema
- Registration Number
- NCT05695248
- Lead Sponsor
- Astria Therapeutics, Inc.
- Brief Summary
The goal of this clinical trial is to test the drug STAR-0215 in participants with hereditary angioedema (HAE). One group of participants will get 1 dose of STAR-0215, and two other groups will get 2 doses of STAR-0215. Researchers will study the effects of STAR-0215 in participants with HAE as this is the first time that the drug has been given to participants with HAE.
- Detailed Description
This is a Phase 1b/2 single and multiple dose trial evaluating the safety, tolerability, clinical activity, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneous administration of STAR-0215 in participants with type I or type II HAE in 3 dose cohorts. The first cohort will receive 1 dose of STAR-0215; the second and third cohorts will receive 2 sequential doses. This is the first trial of STAR-0215 in participants with HAE and the first evaluation of a multiple-dose regimen. After the required follow up period, participants who are willing and eligible to consent can begin participation in the long-term open label extension study (STAR-0215-202, ALPHA-SOLAR).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
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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).
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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.
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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.
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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, within 7 days
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 - Single Dose STAR-0215 Participants will receive 1 dose of STAR-0215. Cohort 3 - Multiple Dose STAR-0215 Participants will receive 2 doses of STAR-0215 administered 1 month apart. Cohort 2 - Multiple Dose STAR-0215 Participants will receive 2 doses of STAR-0215 administered 3 months apart.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Treatment-emergent Adverse Events Day 1 through Day 448 (Cohort 1), Day 531 (Cohort 2), and Day 475 (Cohort 3)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Monthly HAE Attack Rate Baseline through Day 168 (Cohort 1), Day 251 (Cohort 2), and Day 195 (Cohort 3) Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195 Number of Participants with Anti-drug Antibodies To STAR-0215 Cohort 1: Day 1 (pre-dose); Days 14, 28, 56, 84, 112, 140, and 168; Cohort 2: Days 1 and 84 (pre-dose); Days 14, 28, 56, 111, 167, and 251; Cohort 3: Days 1 and 28 (pre-dose); Days 14, 55, 111, and 195 Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.
Serum Concentration of STAR-0215 Cohort 1: Day 1 (pre-dose, 4 hours post dose) up to Day 168; Cohort 2: Days 1 and 84 (pre-dose, 4 hours post dose) up to Day 251; Cohort 3: Days 1 and 28 (pre-dose, 4 hours post dose) up to Day 195 Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.
Duration of HAE Attacks Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195 Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours.
Severity of HAE Attacks Experienced by Participants Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195 All HAE attacks will be classified according to severity (mild, moderate, and severe).
Plasma Levels of Cleaved High-molecular-weight Kininogen Cohort 1: Day 1 (pre-dose, 4 hours post dose) up to Day 168; Cohort 2: Days 1 and 84 (pre-dose, 4 hours post dose) up to Day 251; Cohort 3: Days 1 and 28 (pre-dose, 4 hours post dose) up to Day 195 Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
Time to First HAE Attack After First and Last Dosing Cohort 1: Day 1 through Day 168; Cohort 2: Day 1 through Day 251; Cohort 3: Day 1 through Day 195
Trial Locations
- Locations (20)
Acuro Research, Inc.
🇺🇸Little Rock, Arkansas, United States
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
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
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