A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
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)
2 other identifiers
interventional
56
7 countries
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2023
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedStudy Start
First participant enrolled
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
July 23, 2025
July 1, 2025
7.4 years
August 17, 2023
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Treatment-emergent Adverse Events
Day 1 through study completion, an average of 6 years
Secondary Outcomes (10)
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
Duration of HAE Attacks
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 Each Dose
Day 1 through up to 5 years
- +5 more secondary outcomes
Study Arms (4)
Dose Regimen 1 (Arm A): STAR-0215
EXPERIMENTALParticipants will receive STAR-0215 every 3 months.
Dose Regimen 2 (Arm B): STAR-0215
EXPERIMENTALParticipants will receive STAR-0215 every 6 months.
Dose Regimen 1 (Arm C): STAR-0215
EXPERIMENTALSTAR-0215 will be administered as a subcutaneous injection.
Dose Regimen 3 (Arm D): STAR-0215
EXPERIMENTALSTAR-0215 will be administered as a subcutaneous injection.
Interventions
STAR-0215 will be administered as a subcutaneous injection.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Allervie Clinical Research
Birmingham, Alabama, 35209, United States
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona, 85251, United States
Acuro Research
Little Rock, Arkansas, 72205, United States
UC San Diego US HAEA Angioedema Center
San Diego, California, 92122, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, 90404, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Optimed Research
Columbus, Ohio, 43235, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
AARA Research Center
Dallas, Texas, 75231, United States
Diagnostic Consultative Center Convex Ltd.
Sofia, 1680, Bulgaria
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1H 1E4, Canada
Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
Hradec Králové, 550 05, Czechia
Charité Universitätsmedizin Berlin
Berlin, 12203, Germany
Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt, 60596, Germany
Universitätsklinikum Ulm
Ulm, 89075, Germany
Szpital Uniwersytecki w Krakowie
Krakow, 31-503, Poland
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
St. James's Hospital
Leeds, LS9 7TF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2023
First Posted
August 23, 2023
Study Start
September 26, 2023
Primary Completion (Estimated)
March 1, 2031
Study Completion (Estimated)
March 1, 2031
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share