A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema

Study Overview
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Brief Summary
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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. The trial will continue for up to 5 years.

Official Title
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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)

Conditions
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Hereditary Angioedema

Intervention / Treatment
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* Drug: STAR-0215


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Regimen 1: STAR-0215<br>Participants will receive STAR-0215 every 3 months. | Drug: STAR-0215<br>* STAR-0215 will be administered as a subcutaneous injection.<br>|
| Experimental: Dose Regimen 2: STAR-0215<br>Participants will receive STAR-0215 every 6 months. | Drug: STAR-0215<br>* STAR-0215 will be administered as a subcutaneous injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Treatment-emergent Adverse Events |  | Day 1 through up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Monthly HAE Attack Rate |  | Day 1, up to 5 years | 
| 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 | 
| 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 | 
| Number of Participants Experiencing HAE Attacks Requiring On-demand Therapy |  | Day 1 through up to 5 years | 
| Time to First HAE Attack After First and Last Dosing |  | Day 1 through up to 5 years | 
| 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 | 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HAE, Angioedema, Long-term, Safety