Actively Recruiting
A Study of Navenibart in Participants With Hereditary Angioedema
Led by Astria Therapeutics, Inc. · Updated on 2026-05-04
145
Participants Needed
87
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.
CONDITIONS
Official Title
A Study of Navenibart in Participants With Hereditary Angioedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of type 1 or type 2 hereditary angioedema (HAE) confirmed by clinical history and lab findings
- Experienced at least 2 HAE attacks during the Run-In period confirmed by an investigator
You will not qualify if you...
- Diagnosis of other chronic angioedema forms such as acquired C1 inhibitor deficiency, HAE with normal C1-INH, idiopathic angioedema, or angioedema with urticaria
- Use of HAE attack prevention therapies during the trial or within specific timeframes prior to the Run-In period:
- Tranexamic acid, oral danazol, oral stanazolol, or oral oxandrolone within 3 days prior to Run-In
- Plasma-derived C1INH 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
AI-Screening
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Trial Site Locations
Total: 87 locations
1
Site 9
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Site 2
Scottsdale, Arizona, United States, 85251
Actively Recruiting
3
Site 3
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Site 26
San Diego, California, United States, 92122
Actively Recruiting
5
Site 14
San Diego, California, United States, 92123,
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6
Site 4
Santa Monica, California, United States, 90404
Actively Recruiting
7
Site 1
Walnut Creek, California, United States, 94598
Actively Recruiting
8
Site 8
Centennial, Colorado, United States, 80112
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9
Site 11
Colorado Springs, Colorado, United States, 80907
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10
Site 25
Tampa, Florida, United States, 33613
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11
Site 69
Weston, Florida, United States, 33331
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12
Site 43
Overland Park, Kansas, United States, 66211-1318
Withdrawn
13
Site 6
Wheaton, Maryland, United States, 20902
Actively Recruiting
14
Site 67
Boston, Massachusetts, United States, 02114
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15
Site 13
Detroit, Michigan, United States, 48202
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16
Site 10
St Louis, Missouri, United States, 63141
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17
Site 7
Cincinnati, Ohio, United States, 45236
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18
Site 12
Toledo, Ohio, United States, 43617
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19
Site 15
Hummelstown, Pennsylvania, United States, 17036
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20
Site 86
Dallas, Texas, United States, 75231
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21
Site 68
Campbelltown, New South Wales, Australia, 2560
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22
Site 76
Melbourne, Victoria, Australia
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23
Site 74
Murdoch, Australia, WA 6150
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24
Site 83
Vienna, Austria, 1090
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25
Site 45
Santo André, Brazil, 09060870
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26
Site 28
Sofia, Bulgaria, 1680
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27
Site 5
Ottawa, Ontario, Canada, K1H 1E4
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28
Site 23
Edmonton, Canada, AB T6G 2B7
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29
Site 37
Hradec Králové, Czechia, 500 05
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30
Site 39
Prague, Czechia, 150 06
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31
Site 46
La Tronche, France, 38700
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32
Site 54
Lille, France, 59037
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33
Site 65
Marseille, France, 13005
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34
Site 72
Nice, France, 06202
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35
Site 52
Paris, France, 75012
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36
Site 38
Berlin, Germany, 12203
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37
Site 44
Frankfurt, Germany, D-60590
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38
Site 70
Hanover, Germany, 30625
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39
Site 20
Hong Kong, Hong Kong
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40
Site 64
Budapest, Hungary, 1088
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41
Site 55
Ashkelon, Israel, 7830604
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42
Site 49
Haifa, Israel, 3104802
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43
Site 35
Petah Tikva, Israel, 49100
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44
Site 34
Petah Tikva, Israel, 4920235
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45
Site 53
Tel Aviv, Israel, 6423906
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46
Site 42
Milan, Italy, 20138
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47
Site 85
Milan, Italy, 20157
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48
Sie 51
Monserrato, Italy, 09042
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49
Site 51
Monserrato, Italy, CA 09042
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50
Site 66
Padova, Italy, 35128
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51
Site 40
San Donato Milanese, Italy, 20097
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52
Site 41
Torino, Italy, 10128
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53
Site 30
Fukuoka, Kurume-shi, Japan, 830-0011
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54
Site 56
Tsu, Mei, Japan, 514-8507
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55
Site 61
Kawagoe, Saitama, Japan, 350-8550
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56
Site 31
Saitama, Soka-shi, Japan, 340-0041
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57
Site 57
Hiroshima, Japan, 730-8518
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58
Site 50
Hiroshima, Japan, 734-8551
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59
Site 58
Kawasaki, Japan, 216-8511
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60
Site 80
Nagasaki, Japan, 852-8501
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61
Site 47
Saga, Japan, 849-8501
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62
Site 73
Tokyo, Japan, 173-0032
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63
Site 27
Amsterdam, Netherlands
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64
Site 75
Auckland, New Zealand
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65
Site 33
Skopje, North Macedonia, 1000
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66
Site 71
Krakow, Poland, 31-503
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67
Site 78
Lodz, Poland, 92-213
Actively Recruiting
68
Site 29
Rzeszów, Poland, 35-051
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69
Site 79
Warsaw, Poland, 04-141
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70
Site 81
Coimbra, Portugal, 3004-561
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71
Site 82
Lisbon, Portugal, 1649-028
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72
Site 59
San Juan, Puerto Rico, 00918
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73
Site 21
Cape Town, South Africa, 7700
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74
Site 62
Seoul, Jongno, South Korea
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75
Site 60
Yangcheon, Seoul, South Korea
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76
Site 77
Seongnam-si, South Korea
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77
Site 32
Barcelona, Spain
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78
Site 63
Madrid, Spain, 28007
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79
Site 84
Santa Cruz de Tenerife, Spain, 38010
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80
Site 48
Seville, Spain, 41013
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81
Site 36
Valencia, Spain, 46026
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82
Site 18
Plymouth, Devon, United Kingdom, PL6 8HD
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83
Site 24
Hampstead, London, United Kingdom, NW3 2QG
Actively Recruiting
84
Site 19
Bristol, United Kingdom, BS10 5N
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85
Site 16
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
86
Site 22
Frimley, United Kingdom, GU16 7UJ
Actively Recruiting
87
Site 17
London, United Kingdom, E1 2ES
Actively Recruiting
Research Team
C
Claire VanEenwyk, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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