Hereditary Angioedema
Conditions
Keywords
HAE, Angioedema, Long-term, Safety
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.
Interventions
DRUGSTAR-0215
STAR-0215 will be administered as a subcutaneous injection.
Sponsors
Astria Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through study completion, an average of 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change From Baseline in Monthly HAE Attack Rate | Day 1, 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. |
| 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 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. |
| Number of HAE Attack-free Days | Day 1 through up to 5 years | — |
Countries
Bulgaria, Canada, Czechia, Germany, Poland, United Kingdom, United States
Outcome results
None listed