Phase
Condition
Hives (Urticaria)
Allergy
Urticaria
Treatment
navenibart
Placebo
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Documented diagnosis of HAE (Type 1 or 2). The following must be met:
Documented clinical history consistent with HAE
Lab findings consistent with HAE Type 1 or 2
- 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 3), idiopathicangioedema, or angioedema associated with urticaria.
Use of therapies prescribed for the prevention of HAE attacks may not be used duringthe trial or within the below time frames prior to the Run-In Period (adultparticipants may be on these medications at the time of the Screening Visit, butwill need to washout prior to entering the Run-In Period):
Lanadelumab within 90 days prior to Run-In
Berotralstat within 21 days prior to Run-In
Plasma-derived C1INH for LTP within 14 days prior to Run-In
Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3days prior to Run-In
All other prophylactic therapies, including investigational drugs, requireconsultation with the Medical Monitor
Study Design
Connect with a study center
Site 5
Ottawa, Ontario K1H 1E4
CanadaActive - Recruiting
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Site 2
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Acuro Research, Inc.
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Site 3
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Raffi Tachdjian MD, Inc
Santa Monica, California 90404
United StatesActive - Recruiting
Site 4
Santa Monica, California 90404
United StatesActive - Recruiting
Allergy & Asthma Clinical Research
Walnut Creek, California 94598
United StatesActive - Recruiting
Site 1
Walnut Creek, California 94598
United StatesActive - Recruiting
Site 6
Wheaton, Maryland 20902
United StatesActive - Recruiting
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