Status:
ENROLLING_BY_INVITATION
A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
Lead Sponsor:
Astria Therapeutics, Inc.
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 1\. Participants from STAR-0215-301 who met one of the following conditions:
- Completed STAR-0215-301 through the Day 181 visit
- 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
- 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
- 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.
- Known sensitivity to the ingredients in the formulation of IP
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2031
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT07204938
Start Date
October 1 2025
End Date
December 1 2031
Last Update
November 5 2025
Active Locations (1)
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1
Site 2
Scottsdale, Arizona, United States, 85251