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Enrolling By InvitationPhase 3NCT07204938

A Long-Term Study of Navenibart in Participants With Hereditary Angioedema

This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STA...

Lead sponsor: Astria Therapeutics, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Astria Therapeutics, Inc.

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1\. Participants from STAR-0215-301 who met one of the following conditions:
•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

•1. Participation in an investigational clinical trial other than STAR-0215- 301 in the 30 days or any exposure to an investigational drug (other than navenibart in STAR-0215-301) within 5 half-lives before informed consent/assent
•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 5, 2025Terms

Trial snapshot

StatusENROLLING_BY_INVITATION

PhasePHASE3

Enrollment145

Start dateOct 2025

Last updatedNov 5, 2025

Condition

Hereditary Angioedema (HAE)

Locations shown

Site 2

Scottsdale, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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