Phase
Condition
Hives (Urticaria)
Allergy
Urticaria
Treatment
Placebo
navenibart
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 2172586, New South Wales 2155400 2560
AustraliaActive - Recruiting
Site 76
Melbourne 2158177, Victoria 2145234
AustraliaActive - Recruiting
Site 74
Murdoch 8349091, WA 6150
AustraliaActive - Recruiting
Site 45
Santo André 3449701, 09060870
BrazilActive - Recruiting
Site 28
Sofia 727011, 1680
BulgariaActive - Recruiting
Site 5
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Site 5
Ottawa 6094817, Ontario 6093943 K1H 1E4
CanadaActive - Recruiting
Site 23
Edmonton 5946768, AB T6G 2B7
CanadaActive - Recruiting
Site 37
Hradec Králové 3074967, 500 05
CzechiaActive - Recruiting
Site 39
Prague 3067696, 150 06
CzechiaActive - Recruiting
Site 46
La Tronche 3006131, 38700
FranceActive - Recruiting
Site 54
Lille 2998324, 59037
FranceActive - Recruiting
Site 65
Marseille 2995469, 13005
FranceActive - Recruiting
Site 72
Nice 2990440, 06202
FranceActive - Recruiting
Site 52
Paris 2988507, 75012
FranceActive - Recruiting
Site 38
Berlin 2950159, 12203
GermanyActive - Recruiting
Site 44
Frankfurt 2925536, D-60590
GermanyActive - Recruiting
Site 70
Hanover 2910831, 30625
GermanyActive - Recruiting
Site 20
Hong Kong 1819729,
Hong KongActive - Recruiting
Site 64
Budapest 3054643, 1088
HungaryActive - Recruiting
Site 55
Ashkelon 295620, 7830604
IsraelActive - Recruiting
Site 49
Haifa 294801, 3104802
IsraelActive - Recruiting
Site 34
Petah Tikva 293918, 4920235
IsraelActive - Recruiting
Site 35
Petah Tikva 293918, 49100
IsraelActive - Recruiting
Site 53
Tel Aviv 293397, 6423906
IsraelActive - Recruiting
Site 42
Milan 3173435, 20138
ItalyActive - Recruiting
Sie 51
Monserrato 2524084, 09042
ItalyActive - Recruiting
Site 51
Monserrato 2524084, CA 09042
ItalyActive - Recruiting
Site 66
Padua 3171728, 35128
ItalyActive - Recruiting
Site 40
San Donato Milanese 3168414, 20097
ItalyActive - Recruiting
Site 41
Torino 8980539, 10128
ItalyActive - Recruiting
Site 30
Fukuoka 1863967, Kurume-shi 830-0011
JapanActive - Recruiting
Site 56
Tsu 1849796, Mei 514-8507
JapanActive - Recruiting
Site 61
Kawagoe 1859740, Saitama 1853226 350-8550
JapanActive - Recruiting
Site 31
Saitama 6940394, Soka-shi 340-0041
JapanActive - Recruiting
Site 50
Hiroshima 1862415, 734-8551
JapanActive - Recruiting
Site 57
Hiroshima 1862415, 730-8518
JapanActive - Recruiting
Site 58
Kawasaki 1859642, 216-8511
JapanActive - Recruiting
Site 47
Saga 1853303, 849-8501
JapanActive - Recruiting
Site 73
Tokyo 1850147, 173-0032
JapanActive - Recruiting
Site 27
Amsterdam 2759794,
NetherlandsActive - Recruiting
Site 75
Auckland 2193733,
New ZealandActive - Recruiting
Site 33
Skopje 785842, 1000
North MacedoniaActive - Recruiting
Site 71
Krakow 3094802, 31-503
PolandActive - Recruiting
Site 78
Lodz 3093133, 92-213
PolandActive - Recruiting
Site 29
Rzeszów 759734, 35-051
PolandActive - Recruiting
Site 59
San Juan 4568127, 00918
Puerto RicoActive - Recruiting
Site 21
Cape Town 3369157, 7700
South AfricaActive - Recruiting
Site 62
Seoul 1835848, Jongno
South KoreaActive - Recruiting
Site 60
Yangcheon, Seoul 1835847
South KoreaActive - Recruiting
Site 77
Seongnam-si 1897000,
South KoreaActive - Recruiting
Site 32
Barcelona 3128760,
SpainActive - Recruiting
Site 63
Madrid 3117735, 28007
SpainActive - Recruiting
Site 48
Seville 2510911, 41013
SpainActive - Recruiting
Site 36
Valencia 2509954, 46026
SpainActive - Recruiting
Site 18
Plymouth 2640194, Devon PL6 8HD
United KingdomActive - Recruiting
Site 24
Hampstead 2647553, London NW3 2QG
United KingdomActive - Recruiting
Site 19
Bristol 2654675, BS10 5N
United KingdomActive - Recruiting
Site 16
Cambridge 2653941, CB2 0QQ
United KingdomActive - Recruiting
Site 22
Frimley 2649052, GU16 7UJ
United KingdomActive - Recruiting
Site 17
London 2643743, E1 2ES
United KingdomActive - Recruiting
Site 9
Birmingham, Alabama 35209
United StatesSite Not Available
Site 9
Birmingham 4049979, Alabama 4829764 35209
United StatesActive - 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 StatesSite Not Available
Site 2
Scottsdale 5313457, Arizona 5551752 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 StatesSite Not Available
Site 3
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
Site 14
San Diego, California 92123,
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 26
San Diego 5391811, California 5332921 92122
United StatesActive - Recruiting
Site 4
Santa Monica 5393212, California 5332921 90404
United StatesActive - Recruiting
Site 1
Walnut Creek 5406990, California 5332921 94598
United StatesActive - Recruiting
Site 8
Centennial, Colorado 80112
United StatesSite Not Available
Site 11
Colorado Springs, Colorado 80907
United StatesSite Not Available
Site 8
Centennial 5416541, Colorado 5417618 80112
United StatesActive - Recruiting
Site 11
Colorado Springs 5417598, Colorado 5417618 80907
United StatesActive - Recruiting
Site 25
Tampa 4174757, Florida 4155751 33613
United StatesActive - Recruiting
Site 69
Weston 4178003, Florida 4155751 33331
United StatesActive - Recruiting
Site 43
Overland Park 4276873, Kansas 4273857 66211-1318
United StatesSite Not Available
Site 6
Wheaton, Maryland 20902
United StatesSite Not Available
Site 6
Wheaton 4373349, Maryland 4361885 20902
United StatesActive - Recruiting
Site 67
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Site 13
Detroit, Michigan 48202
United StatesSite Not Available
Site 13
Detroit 4990729, Michigan 5001836 48202
United StatesActive - Recruiting
Site 10
St. Louis, Missouri 63141
United StatesSite Not Available
Site 10
St Louis 4407066, Missouri 4398678 63141
United StatesActive - Recruiting
Site 7
Cincinnati, Ohio 45236
United StatesSite Not Available
Site 12
Toledo, Ohio 43617
United StatesSite Not Available
Site 7
Cincinnati 4508722, Ohio 5165418 45236
United StatesActive - Recruiting
Site 12
Toledo 5174035, Ohio 5165418 43617
United StatesActive - Recruiting
Site 15
Hummelstown 5194513, Pennsylvania 6254927 17036
United StatesActive - Recruiting

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