Phase
Condition
Allergy
Hereditary Angioedema
Urticaria
Treatment
STAR-0215
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented diagnosis of HAE (type I or II). The following must be met: a. Documented clinical history consistent with HAE (for example, subcutaneous ormucosal, nonpruritic swelling episodes without accompanying urticaria).
Experienced at least 2 HAE attacks during the Run-In period, as confirmed by aninvestigator based on meeting the protocol-specified definition of an HAE attack.
Exclusion
Exclusion Criteria:
Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1inhibitor deficiency, HAE with normal C1-INH (also known as HAE type III),idiopathic angioedema, or angioedema associated with urticaria.
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, within 7 days
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.
Study Design
Study Description
Connect with a study center
Diagnostical Consultative Center Convex Ltd.
Sofia, 1680
BulgariaSite Not Available
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 Králové, 500 05
CzechiaSite Not Available
Charité Universitätsmedizin Berlin
Berlin, 12203
GermanySite Not Available
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United KingdomSite Not Available
St. James's Hospital
Leeds, LS9 7TF
United KingdomSite Not Available
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
Allergy & Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas 72712
United StatesSite Not Available
Acuro Research, Inc.
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 StatesSite Not Available
Raffi Tachdjian MD, Inc
Santa Monica, California 90404
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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