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: Recruiting
Location: See all (76) 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
RECRUITING
Birmingham
Arkansas
Site 3
RECRUITING
Little Rock
Arizona
Site 2
RECRUITING
Scottsdale
California
Site 14
RECRUITING
San Diego
Site 26
RECRUITING
San Diego
Site 4
RECRUITING
Santa Monica
Site 1
RECRUITING
Walnut Creek
Colorado
Site 8
RECRUITING
Centennial
Site 11
RECRUITING
Colorado Springs
Florida
Site 25
RECRUITING
Tampa
Site 69
RECRUITING
Weston
Kansas
Site 43
WITHDRAWN
Overland Park
Massachusetts
Site 67
RECRUITING
Boston
Maryland
Site 6
RECRUITING
Wheaton
Michigan
Site 13
RECRUITING
Detroit
Missouri
Site 10
RECRUITING
St Louis
Ohio
Site 7
RECRUITING
Cincinnati
Site 12
RECRUITING
Toledo
Pennsylvania
Site 15
RECRUITING
Hummelstown
Other Locations
Australia
Site 68
RECRUITING
Campbelltown
Site 76
RECRUITING
Melbourne
Site 74
RECRUITING
Murdoch
Brazil
Site 45
RECRUITING
Santo André
Bulgaria
Site 28
RECRUITING
Sofia
Canada
Site 23
RECRUITING
Edmonton
Site 5
RECRUITING
Ottawa
France
Site 46
RECRUITING
La Tronche
Site 54
RECRUITING
Lille
Site 65
RECRUITING
Marseille
Site 72
RECRUITING
Nice
Site 52
RECRUITING
Paris
Germany
Site 38
RECRUITING
Berlin
Site 44
RECRUITING
Frankfurt
Site 70
RECRUITING
Hanover
Hong Kong Special Administrative Region
Site 20
RECRUITING
Hong Kong
Hungary
Site 64
RECRUITING
Budapest
Israel
Site 55
RECRUITING
Ashkelon
Site 49
RECRUITING
Haifa
Site 34
RECRUITING
Petah Tikva
Site 35
RECRUITING
Petah Tikva
Site 53
RECRUITING
Tel Aviv
Italy
Site 42
RECRUITING
Milan
Sie 51
RECRUITING
Monserrato
Site 51
RECRUITING
Monserrato
Site 66
RECRUITING
Padua
Site 40
RECRUITING
San Donato Milanese
Site 41
RECRUITING
Torino
Japan
Site 30
RECRUITING
Fukuoka
Site 50
RECRUITING
Hiroshima
Site 57
RECRUITING
Hiroshima
Site 61
RECRUITING
Kawagoe
Site 58
RECRUITING
Kawasaki
Site 47
RECRUITING
Saga
Site 31
RECRUITING
Saitama
Site 73
RECRUITING
Tokyo
Site 56
RECRUITING
Tsu
Netherlands
Site 27
RECRUITING
Amsterdam
New Zealand
Site 75
RECRUITING
Auckland
Poland
Site 71
RECRUITING
Krakow
Site 78
RECRUITING
Lodz
Site 29
RECRUITING
Rzeszów
Puerto Rico
Site 59
RECRUITING
San Juan
Republic of Korea
Site 77
RECRUITING
Seongnam-si
Site 62
RECRUITING
Seoul
Site 60
RECRUITING
Yangcheon
South Africa
Site 21
RECRUITING
Cape Town
Spain
Site 32
RECRUITING
Barcelona
Site 63
RECRUITING
Madrid
Site 48
RECRUITING
Seville
Site 36
RECRUITING
Valencia
United Kingdom
Site 19
RECRUITING
Bristol
Site 16
RECRUITING
Cambridge
Site 22
RECRUITING
Frimley
Site 24
RECRUITING
Hampstead
Site 17
RECRUITING
London
Site 18
RECRUITING
Plymouth
Contact Information
Primary
Claire VanEenwyk, MD
alphaorbit_general@astriatx.com
1-617-349-1971
Time Frame
Start Date: 2025-03-20
Estimated 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.