A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
Enrolling by invitation · Phase 3 · Has a placebo group
Conditions studied: Hereditary Angioedema (HAE)
In brief
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.
Key facts
- Study ID
- NCT07204938
- Run by
- Astria Therapeutics, Inc.
- People needed
- 145
- Starts
- 2025-10-01
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Site 2 — Scottsdale, Arizona, United States
- Site 3 — Little Rock, Arkansas, United States
- Site 7 — San Diego, California, United States
- Site 4 — Santa Monica, California, United States
- Site 1 — Walnut Creek, California, United States
- Site 5 — Centennial, Colorado, United States
- Site 19 — Colorado Springs, Colorado, United States
- Site 21 — Wheaton, Maryland, United States
- Site 6 — Cincinnati, Ohio, United States
- Site 9 — Hershey, Pennsylvania, United States
- 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, Japan
- Site 27 — Fukuoka, Japan
Full record on ClinicalTrials.gov
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