A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)
Status: Enrolling_by_invitation
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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 an investigator based on meeting the protocol-specified definition of an HAE attack.
Locations
United States
Alabama
Site 9
Birmingham
Arkansas
Site 3
Little Rock
Arizona
Site 2
Scottsdale
California
Site 14
San Diego
Site 26
San Diego
Site 4
Santa Monica
Site 1
Walnut Creek
Colorado
Site 8
Centennial
Site 11
Colorado Springs
Florida
Site 25
Tampa
Site 69
Weston
Massachusetts
Site 67
Boston
Maryland
Site 6
Wheaton
Michigan
Site 13
Detroit
Missouri
Site 10
St Louis
Ohio
Site 7
Cincinnati
Site 12
Toledo
Pennsylvania
Site 15
Hummelstown
Texas
Site 86
Dallas
Other Locations
Australia
Site 68
Campbelltown
Site 76
Melbourne
Site 74
Murdoch
Austria
Site 83
Vienna
Brazil
Site 45
Santo André
Bulgaria
Site 28
Sofia
Canada
Site 23
Edmonton
Site 5
Ottawa
France
Site 46
La Tronche
Site 54
Lille
Site 65
Marseille
Site 72
Nice
Site 52
Paris
Germany
Site 38
Berlin
Site 44
Frankfurt
Site 70
Hanover
Hong Kong Special Administrative Region
Site 20
Hong Kong
Hungary
Site 64
Budapest
Israel
Site 55
Ashkelon
Site 49
Haifa
Site 34
Petah Tikva
Site 35
Petah Tikva
Site 53
Tel Aviv
Italy
Site 42
Milan
Site 85
Milan
Sie 51
Monserrato
Site 51
Monserrato
Site 66
Padova
Site 40
San Donato Milanese
Site 41
Torino
Japan
Site 30
Fukuoka
Site 50
Hiroshima
Site 57
Hiroshima
Site 61
Kawagoe
Site 58
Kawasaki
Site 80
Nagasaki
Site 47
Saga
Site 31
Saitama
Site 73
Tokyo
Site 56
Tsu
Netherlands
Site 27
Amsterdam
New Zealand
Site 75
Auckland
Poland
Site 71
Krakow
Site 78
Lodz
Site 29
Rzeszów
Site 79
Warsaw
Portugal
Site 81
Coimbra
Site 82
Lisbon
Puerto Rico
Site 59
San Juan
Republic of Korea
Site 77
Seongnam-si
Site 62
Seoul
Site 60
Yangcheon
South Africa
Site 21
Cape Town
Spain
Site 32
Barcelona
Site 63
Madrid
Site 84
Santa Cruz De Tenerife
Site 48
Seville
Site 36
Valencia
United Kingdom
Site 19
Bristol
Site 16
Cambridge
Site 22
Frimley
Site 24
Hampstead
Site 17
London
Site 18
Plymouth
Time Frame
Start Date: 2025-03-20
Completion Date: 2027-09
Participants
Target number of participants: 145
Treatments
Experimental: Adult Navenibart Dosing Regimen 1
Participants will receive 600 mg of navenibart every 3 months.
Experimental: Adult Navenibart Dosing Regimen 2
Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
Experimental: Adult Navenibart Dosing Regimen 3
Participants will receive 600 mg of navenibart every 6 months.
Placebo_comparator: Placebo (adult)
Participants will receive placebo every 3 months.
Experimental: Adolescent Navenibart Dosing Regimen 1
Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3.
Related Therapeutic Areas
Sponsors
Leads: Astria Therapeutics, Inc.