A Study of Navenibart in Participants With Hereditary Angioedema
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Hereditary Angioedema (HAE)
In brief
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.
Key facts
- Study ID
- NCT06842823
- Run by
- Astria Therapeutics, Inc.
- People needed
- 157
- Starts
- 2025-03-20
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-06-30
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented diagnosis of HAE (Type 1 or 2). The following must be met:
- Documented clinical history consistent with HAE
- Lab findings consistent with HAE Type 1 or 2
- Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
You may not qualify if…
- Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.
- Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period).
- Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
- Plasma-derived C1INH for LTP within 14 days prior to Run-In
- Berotralstat within 21 days prior to Run-In
- Lanadelumab within 70 days prior to Run-In
- Garadacimab within 90 days prior to Run-In
Where it is running
- Site 2 — Scottsdale, Arizona, United States
- Site 3 — Little Rock, Arkansas, United States
- Site 26 — San Diego, California, United States
- Site 14 — San Diego, California, United States
- Site 4 — Santa Monica, California, United States
- Site 1 — Walnut Creek, California, United States
- Site 8 — Centennial, Colorado, United States
- Site 11 — Colorado Springs, Colorado, United States
- Site 25 — Tampa, Florida, United States
- Site 69 — Weston, Florida, United States
- Site 6 — Wheaton, Maryland, United States
- Site 67 — Boston, Massachusetts, United States
- Site 13 — Detroit, Michigan, United States
- Site 10 — St Louis, Missouri, United States
- Site 7 — Cincinnati, Ohio, United States
- Site 12 — Toledo, Ohio, United States
- Site 15 — Hummelstown, Pennsylvania, United States
- Site 86 — Dallas, Texas, United States
- Site 68 — Campbelltown, New South Wales, Australia
- Site 76 — Melbourne, Victoria, Australia
- Site 74 — Murdoch, Australia
- Site 83 — Vienna, Austria
- Site 45 — Santo André, Brazil
- Site 28 — Sofia, Bulgaria
- Site 9 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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