Hereditary Angioedema Clinical Trial
Official title:
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)
Verified date | April 2024 |
Source | Astria Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 56 |
Est. completion date | August 2030 |
Est. primary completion date | August 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | Ottawa Allergy Research Corporation | Ottawa | Ontario |
United States | Alabama Allervie Clinical Research | Birmingham | Alabama |
United States | Institute for Asthma and Allergy, PC | Chevy Chase | Maryland |
United States | Optimed Research | Columbus | Ohio |
United States | AARA Research Center | Dallas | Texas |
United States | Little Rock Allergy & Asthma Clinical Research Center | Little Rock | Arkansas |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Raffi Tachdjian MD, Inc | Santa Monica | California |
United States | Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD | Scottsdale | Arizona |
United States | Allergy & Asthma Clinical Research | Walnut Creek | California |
Lead Sponsor | Collaborator |
---|---|
Astria Therapeutics, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through up to 6 years and 4 months | ||
Secondary | Change From Baseline in Monthly HAE Attack Rate | Day 1, up to 5 years | ||
Secondary | Severity of HAE Attacks Experienced by Participants | All HAE attacks will be classified according to severity (mild, moderate, and severe). | Day 1 through up to 5 years | |
Secondary | Duration of HAE Attacks | Duration will be reported as shorter than 12 hours, 12 to 24 hours, 24 to 48 hours, and longer than 48 hours. | Day 1 through up to 5 years | |
Secondary | Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy | Day 1 through up to 5 years | ||
Secondary | Time to First HAE Attack After Each Dose | Day 1 through up to 5 years | ||
Secondary | Number of HAE Attack-free Days | Day 1 through up to 5 years | ||
Secondary | Number of Participants Experiencing Zero HAE Attacks | Day 1 through up to 5 years | ||
Secondary | Serum Concentration of STAR-0215 | Blood samples will be collected on dosing days to measure the serum concentration of STAR-0215. | Every 3 months for first 2 years, Every 6 months for next 3 years | |
Secondary | Plasma Levels of Cleaved High-molecular-weight Kininogen | 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). | Every 3 months for first 2 years, Every 6 months for next 3 years | |
Secondary | Number of Participants with Anti-drug Antibodies to STAR-0215 | Blood samples will be collected on dosing days to assess the formation of STAR-0215 anti-drug antibodies in serum. | Every 3 months for first 2 years, Every 6 months for next 3 years |
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