A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
NCT ID: NCT07204938
Last Updated: 2025-11-05
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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ENROLLING_BY_INVITATION
PHASE3
145 participants
INTERVENTIONAL
2025-10-01
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Adult Dosing Regimen 1
Participants will receive 600 mg of navenibart every 3 months.
navenibart
Navenibart will be administered as a subcutaneous injection.
Adult Dosing Regimen 2
Participants will receive 300 mg of navenibart every 3 months.
navenibart
Navenibart will be administered as a subcutaneous injection.
Adult Dosing Regimen 3
Participants will receive 600 mg of navenibart every 6 months.
navenibart
Navenibart will be administered as a subcutaneous injection.
Adolescent Dosing Regimen 1
Participants will receive 300 mg of navenibart every 3 months.
navenibart
Navenibart will be administered as a subcutaneous injection.
Interventions
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navenibart
Navenibart will be administered as a subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Completed STAR-0215-301 through the Day 181 visit
2. Withdrew from STAR-0215-301 but met the following criteria:
i. Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the second dose of IP iii. Met other eligibility criteria as assessed by Investigator
Exclusion Criteria
2. Any exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 30 days before Screening.
3. Known sensitivity to the ingredients in the formulation of IP
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 2
Scottsdale, Arizona, United States
Countries
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Other Identifiers
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STAR-0215-302
Identifier Type: -
Identifier Source: org_study_id
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