Clinical Trials in Poland / NCT06007677
Active, not recruiting
Phase 2
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
NCT06007677 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Hereditary Angioedema
Investigational drug(s) / intervention(s)
STAR-0215: STAR-0215 will be administered as a subcutaneous injection.
Study 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.
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).
* 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 exclusion criteria may apply.
Primary outcome measure(s)
- Number of Participants Experiencing Treatment-emergent Adverse Events — Day 1 through study completion, an average of 6 years
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | |
| Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD | Scottsdale | Arizona | |
| Acuro Research | Little Rock | Arkansas | |
| UC San Diego US HAEA Angioedema Center | San Diego | California | |
| Raffi Tachdjian MD, Inc | Santa Monica | California | |
| Allergy & Asthma Clinical Research | Walnut Creek | California | |
| Institute for Asthma and Allergy, PC | Chevy Chase | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Washington University School of Medicine | St Louis | Missouri | |
| Optimed Research | Columbus | Ohio | |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | |
| AARA Research Center | Dallas | Texas | |
| Diagnostic Consultative Center Convex Ltd. | Sofia | Bulgaria | |
| University of Alberta | Edmonton | Alberta | |
| Ottawa Allergy Research Corporation | Ottawa | Ontario | |
| Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove | Hradec Králové | Czechia | |
| Charité Universitätsmedizin Berlin | Berlin | Germany | |
| Johann Wolfgang Goethe-Universität Frankfurt | Frankfurt | Germany | |
| Universitätsklinikum Ulm | Ulm | Germany | |
| Szpital Uniwersytecki w Krakowie | Krakow | Poland | |
| Addenbrooke's Hospital | Cambridge | United Kingdom | |
| St. James's Hospital | Leeds | United Kingdom |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06007677 on ClinicalTrials.gov ↗ ← All trials in Poland