Phase
Condition
Allergies & Asthma
Allergy
Urticaria
Treatment
STAR-0215
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Open to participants from STAR-0215-201 (NCT05695248) who have met one of thefollowing 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 qualifyfor the Treatment Period because they did not meet the criterion for theminimum number of HAE attacks;
Eligible for STAR-0215-201 and entered the Run-In period but did not completeit for reasons other than not meeting the criterion for the minimum number ofHAE attacks (eligibility requires consultation with the Medical Monitor); or
Discontinued STAR-0215-201 (for reasons other than safety) after havingcompleted at least 84 days of trial follow-up since their last dose ofSTAR-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
Exclusion Criteria:
Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known asHAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containingmedications with systemic absorption (such as hormonal contraceptives or hormonereplacement 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.
Study Design
Connect with a study center
Diagnostic Consultative Center Convex Ltd.
Sofia, 1680
BulgariaActive - Recruiting
University of Alberta
Edmonton, Alberta T6G 2R3
CanadaSite Not Available
Ottawa Allergy Research Corporation
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Institute of Clinical Immunology/Allergology, Faculty Hospital, Hradec Kralove
Hradec Králové, 550 05
CzechiaActive - Recruiting
Charité Universitätsmedizin Berlin
Berlin, 12203
GermanyActive - Recruiting
Universitätsklinikum Frankfurt
Frankfurt, 60596
GermanyActive - Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
St. James's Hospital
Leeds, LS9 7TF
United KingdomActive - Recruiting
Alabama Allervie Clinical Research
Birmingham, Alabama 35209
United StatesSite Not Available
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona 85251
United StatesSite Not Available
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD
Scottsdale, Arizona 85251
United StatesSite Not Available
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas 72205
United StatesSite Not Available
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas 72205
United StatesSite Not Available
UC San Diego US HAEA Angioedema Center
San Diego, California 92122
United StatesActive - Recruiting
Raffi Tachdjian MD, Inc
Santa Monica, California 90404
United StatesSite Not Available
Allergy & Asthma Clinical Research
Walnut Creek, California 94598
United StatesSite Not Available
Allergy & Asthma Clinical Research
Walnut Creek, California 94598
United StatesSite Not Available
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland 20815
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Optimed Research
Columbus, Ohio 43235
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
AARA Research Center
Dallas, Texas 75231
United StatesSite Not Available
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