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Clinical Trials in the UK / NCT07204938
Enrolling by invitation Phase 3

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

NCT07204938 · tracked via the Priya Life Science UK tracker
Sponsor
Astria Therapeutics, Inc.
Phase
Phase 3
Started
2025-10-01
Last updated
2026-07-30

Condition(s) studied

Hereditary Angioedema (HAE)

Investigational drug(s) / intervention(s)

navenibart

navenibart: Navenibart will be administered as a subcutaneous injection.

Study 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 STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.

Eligibility

Sex
ALL
Min age
12 Years
Max age
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

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Site 2 Scottsdale Arizona
Site 3 Little Rock Arkansas
Site 7 San Diego California
Site 4 Santa Monica California
Site 1 Walnut Creek California
Site 5 Centennial Colorado
Site 19 Colorado Springs Colorado
Site 21 Wheaton Maryland
Site 6 Cincinnati Ohio
Site 9 Hershey Pennsylvania
Site 22 Santo André Brazil
Site 20 Sofia Bulgaria
Site 23 Edmonton Canada
Site 36 Prague Czechia
Site 39 Paris France
Site 25 Frankfurt Germany
Site 10 Hong Kong Hong Kong
Site 29 Ashkelon Israel
Site 30 Haifa Israel
Site 31 Petah Tikva Israel
Site 24 Petah Tikva Israel
Site 37 Milan Italy
Site 38 Monserrato Italy
Site 40 Kawagoe Saitama
Site 27 Fukuoka Japan
Site 33 Kawasaki Japan
Site 17 Amsterdam Netherlands
Site 18 Skopje North Macedonia
Site 35 Krakow Poland
Site 16 Rzeszów Poland
Site 32 San Juan Puerto Rico
Site 11 Cape Town South Africa
Site 34 Madrid Spain
Site 26 Valencia Spain
Site 12 Bristol United Kingdom
Site 8 Cambridge United Kingdom
Site 28 Frimley United Kingdom
Site 15 Hampstead United Kingdom
Site 13 London United Kingdom
Site 14 Plymouth United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204938 on ClinicalTrials.gov ↗ ← All trials in the UK