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A Study of Navenibart in Participants With Hereditary Angioedema
Sponsor: Astria Therapeutics, Inc.
Summary
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.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
145
Start Date
2025-03-20
Completion Date
2027-09
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
navenibart
Navenibart will be administered as a subcutaneous injection.
Placebo
Placebo will be administered as a subcutaneous injection.
Locations (85)
Site 9
Birmingham, Alabama, United States
Site 2
Scottsdale, Arizona, United States
Site 3
Little Rock, Arkansas, United States
Site 26
San Diego, California, United States
Site 14
San Diego, California, United States
Site 4
Santa Monica, California, United States
Site 1
Walnut Creek, California, United States
Site 8
Centennial, Colorado, United States
Site 11
Colorado Springs, Colorado, United States
Site 25
Tampa, Florida, United States
Site 69
Weston, Florida, United States
Site 43
Overland Park, Kansas, United States
Site 6
Wheaton, Maryland, United States
Site 67
Boston, Massachusetts, United States
Site 13
Detroit, Michigan, United States
Site 10
St Louis, Missouri, United States
Site 7
Cincinnati, Ohio, United States
Site 12
Toledo, Ohio, United States
Site 15
Hummelstown, Pennsylvania, United States
Site 68
Campbelltown, New South Wales, Australia
Site 76
Melbourne, Victoria, Australia
Site 74
Murdoch, Australia
Site 83
Vienna, Austria
Site 45
Santo André, Brazil
Site 28
Sofia, Bulgaria
Site 5
Ottawa, Ontario, Canada
Site 23
Edmonton, Canada
Site 37
Hradec Králové, Czechia
Site 39
Prague, Czechia
Site 46
La Tronche, France
Site 54
Lille, France
Site 65
Marseille, France
Site 72
Nice, France
Site 52
Paris, France
Site 38
Berlin, Germany
Site 44
Frankfurt, Germany
Site 70
Hanover, Germany
Site 20
Hong Kong, Hong Kong
Site 64
Budapest, Hungary
Site 55
Ashkelon, Israel
Site 49
Haifa, Israel
Site 35
Petah Tikva, Israel
Site 34
Petah Tikva, Israel
Site 53
Tel Aviv, Israel
Site 42
Milan, Italy
Sie 51
Monserrato, Italy
Site 51
Monserrato, Italy
Site 66
Padova, Italy
Site 40
San Donato Milanese, Italy
Site 41
Torino, Italy
Site 30
Fukuoka, Kurume-shi, Japan
Site 56
Tsu, Mei, Japan
Site 61
Kawagoe, Saitama, Japan
Site 31
Saitama, Soka-shi, Japan
Site 57
Hiroshima, Japan
Site 50
Hiroshima, Japan
Site 58
Kawasaki, Japan
Site 80
Nagasaki, Japan
Site 47
Saga, Japan
Site 73
Tokyo, Japan
Site 27
Amsterdam, Netherlands
Site 75
Auckland, New Zealand
Site 33
Skopje, North Macedonia
Site 71
Krakow, Poland
Site 78
Lodz, Poland
Site 29
Rzeszów, Poland
Site 79
Warsaw, Poland
Site 81
Coimbra, Portugal
Site 82
Lisbon, Portugal
Site 59
San Juan, Puerto Rico
Site 21
Cape Town, South Africa
Site 62
Seoul, Jongno, South Korea
Site 60
Yangcheon, Seoul, South Korea
Site 77
Seongnam-si, South Korea
Site 32
Barcelona, Spain
Site 63
Madrid, Spain
Site 84
Santa Cruz de Tenerife, Spain
Site 48
Seville, Spain
Site 36
Valencia, Spain
Site 18
Plymouth, Devon, United Kingdom
Site 24
Hampstead, London, United Kingdom
Site 19
Bristol, United Kingdom
Site 16
Cambridge, United Kingdom
Site 22
Frimley, United Kingdom
Site 17
London, United Kingdom