Phase
Condition
Allergy
Urticaria
Hives (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).
Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3days prior to Run-In
Plasma-derived C1INH for LTP within 14 days prior to Run-In
Berotralstat within 21 days prior to Run-In
Lanadelumab within 70 days prior to Run-In
Garadacimab within 90 days prior to Run-In
Study Design
Connect with a study center
Site 68
Campbelltown, New South Wales 2560
AustraliaSite Not Available
Site 76
Melbourne, Victoria
AustraliaSite Not Available
Site 74
Murdoch, WA 6150
AustraliaSite Not Available
Site 83
Vienna, 1090
AustriaSite Not Available
Site 45
Santo André, 09060870
BrazilSite Not Available
Site 28
Sofia, 1680
BulgariaSite Not Available
Site 5
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Site 23
Edmonton, AB T6G 2B7
CanadaSite Not Available
Site 37
Hradec Králové, 500 05
CzechiaSite Not Available
Site 39
Prague, 150 06
CzechiaSite Not Available
Site 46
La Tronche, 38700
FranceSite Not Available
Site 54
Lille, 59037
FranceSite Not Available
Site 65
Marseille, 13005
FranceSite Not Available
Site 72
Nice, 06202
FranceSite Not Available
Site 52
Paris, 75012
FranceSite Not Available
Site 38
Berlin, 12203
GermanySite Not Available
Site 44
Frankfurt, D-60590
GermanySite Not Available
Site 70
Hanover, 30625
GermanySite Not Available
Site 20
Hong Kong,
Hong KongSite Not Available
Site 64
Budapest, 1088
HungarySite Not Available
Site 55
Ashkelon, 7830604
IsraelSite Not Available
Site 49
Haifa, 3104802
IsraelSite Not Available
Site 34
Petah Tikva, 4920235
IsraelSite Not Available
Site 35
Petah Tikva, 49100
IsraelSite Not Available
Site 35
Petah Tikva 293918, 49100
IsraelActive - Recruiting
Site 53
Tel Aviv, 6423906
IsraelSite Not Available
Site 42
Milan, 20138
ItalySite Not Available
Site 85
Milan, 20157
ItalySite Not Available
Sie 51
Monserrato, 09042
ItalySite Not Available
Site 51
Monserrato, CA 09042
ItalySite Not Available
Site 51
Monserrato 2524084, CA 09042
ItalyActive - Recruiting
Site 66
Padova, 35128
ItalySite Not Available
Site 40
San Donato Milanese, 20097
ItalySite Not Available
Site 41
Torino, 10128
ItalySite Not Available
Site 30
Fukuoka, Kurume-shi 830-0011
JapanSite Not Available
Site 56
Tsu, Mei 514-8507
JapanSite Not Available
Site 61
Kawagoe, Saitama 350-8550
JapanSite Not Available
Site 31
Saitama, Soka-shi 340-0041
JapanSite Not Available
Site 50
Hiroshima, 734-8551
JapanSite Not Available
Site 57
Hiroshima, 730-8518
JapanSite Not Available
Site 50
Hiroshima 1862415, 734-8551
JapanActive - Recruiting
Site 58
Kawasaki, 216-8511
JapanSite Not Available
Site 80
Nagasaki, 852-8501
JapanSite Not Available
Site 47
Saga, 849-8501
JapanSite Not Available
Site 73
Tokyo, 173-0032
JapanSite Not Available
Site 27
Amsterdam,
NetherlandsSite Not Available
Site 75
Auckland,
New ZealandSite Not Available
Site 33
Skopje, 1000
North MacedoniaSite Not Available
Site 71
Krakow, 31-503
PolandSite Not Available
Site 78
Lodz, 92-213
PolandSite Not Available
Site 29
Rzeszów, 35-051
PolandSite Not Available
Site 79
Warsaw, 04-141
PolandSite Not Available
Site 81
Coimbra, 3004-561
PortugalSite Not Available
Site 82
Lisbon, 1649-028
PortugalSite Not Available
Site 59
San Juan, 00918
Puerto RicoSite Not Available
Site 21
Cape Town, 7700
South AfricaSite Not Available
Site 62
Seoul, Jongno
South KoreaSite Not Available
Site 60
Yangcheon, Seoul
South KoreaSite Not Available
Site 77
Seongnam-si,
South KoreaSite Not Available
Site 32
Barcelona,
SpainSite Not Available
Site 63
Madrid, 28007
SpainSite Not Available
Site 84
Santa Cruz de Tenerife, 38010
SpainSite Not Available
Site 48
Seville, 41013
SpainSite Not Available
Site 36
Valencia, 46026
SpainSite Not Available
Site 18
Plymouth, Devon PL6 8HD
United KingdomSite Not Available
Site 24
Hampstead, London NW3 2QG
United KingdomSite Not Available
Site 19
Bristol, BS10 5N
United KingdomSite Not Available
Site 16
Cambridge, CB2 0QQ
United KingdomSite Not Available
Site 22
Frimley, GU16 7UJ
United KingdomSite Not Available
Site 17
London, E1 2ES
United KingdomSite Not Available
Site 9
Birmingham, Alabama 35209
United StatesSite Not Available
Medical Research of Arizona a Division of Allergy, Asthma & Immunology Associates, LTD.
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Site 2
Scottsdale, Arizona 85251
United StatesSite Not Available
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 StatesSite Not Available
Site 14
San Diego, California 92123,
United StatesSite Not Available
Site 26
San Diego, California 92122
United StatesSite Not Available
Raffi Tachdjian MD, Inc
Santa Monica, California 90404
United StatesActive - Recruiting
Site 4
Santa Monica, California 90404
United StatesSite Not Available
Allergy & Asthma Clinical Research
Walnut Creek, California 94598
United StatesActive - Recruiting
Site 1
Walnut Creek, California 94598
United StatesSite Not Available
Site 14
San Diego 5391811, California 5332921 92123,
United StatesActive - Recruiting
Site 8
Centennial, Colorado 80112
United StatesSite Not Available
Site 11
Colorado Springs, Colorado 80907
United StatesSite Not Available
Site 25
Tampa, Florida 33613
United StatesSite Not Available
Site 69
Weston, Florida 33331
United StatesSite Not Available
Site 6
Wheaton, Maryland 20902
United StatesSite Not Available
Site 67
Boston, Massachusetts 02114
United StatesSite Not Available
Site 13
Detroit, Michigan 48202
United StatesSite Not Available
Site 10
St Louis, Missouri 63141
United StatesSite Not Available
Site 7
Cincinnati, Ohio 45236
United StatesSite Not Available
Site 12
Toledo, Ohio 43617
United StatesSite Not Available
Site 15
Hummelstown, Pennsylvania 17036
United StatesSite Not Available
Site 86
Dallas, Texas 75231
United StatesSite Not Available

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