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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506540-16 | EudraCT Number |
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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 for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Regimen 1 (Arm A): STAR-0215 | Experimental | Participants will receive STAR-0215 every 3 months. |
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| Dose Regimen 2 (Arm B): STAR-0215 | Experimental | Participants will receive STAR-0215 every 6 months. |
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| Dose Regimen 1 (Arm C): STAR-0215 | Experimental | STAR-0215 will be administered as a subcutaneous injection. |
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| Dose Regimen 3 (Arm D): STAR-0215 | Experimental | STAR-0215 will be administered as a subcutaneous injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR-0215 | Drug | STAR-0215 will be administered as a subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through study completion, an average of 6 years |
| 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). |
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Inclusion Criteria:
Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
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:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | United States | ||
| Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD |
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| 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 Each Dose | 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 |
| 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 |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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