A Study of Navenibart in Participants With Hereditary Angioedema
NCT ID: NCT06842823
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
145 participants
INTERVENTIONAL
2025-03-20
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Adult Navenibart Dosing Regimen 1
Participants will receive 600 mg of navenibart every 3 months.
navenibart
Navenibart will be administered as a subcutaneous injection.
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.
navenibart
Navenibart will be administered as a subcutaneous injection.
Adult Navenibart Dosing Regimen 3
Participants will receive 600 mg of navenibart every 6 months.
navenibart
Navenibart will be administered as a subcutaneous injection.
Placebo (adult)
Participants will receive placebo every 3 months.
Placebo
Placebo will be administered as a subcutaneous injection.
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.
navenibart
Navenibart will be administered as a subcutaneous injection.
Interventions
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navenibart
Navenibart will be administered as a subcutaneous injection.
Placebo
Placebo will be administered as a subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Documented clinical history consistent with HAE
2. 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.
Exclusion Criteria
* Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period).
1. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
2. Plasma-derived C1INH for LTP within 14 days prior to Run-In
3. Berotralstat within 21 days prior to Run-In
4. Lanadelumab within 70 days prior to Run-In
5. Garadacimab within 90 days prior to Run-In
12 Years
ALL
No
Sponsors
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Astria Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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 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
Padua, , 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 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 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 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
Countries
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Central Contacts
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Other Identifiers
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STAR-0215-301
Identifier Type: -
Identifier Source: org_study_id
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