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Clinical Trials in the UK / NCT06842823
Active, not recruiting Phase 3

A Study of Navenibart in Participants With Hereditary Angioedema

NCT06842823 · tracked via the Priya Life Science UK tracker
Sponsor
Astria Therapeutics, Inc.
Phase
Phase 3
Started
2025-03-20
Last updated
2026-06-30

Condition(s) studied

Hereditary Angioedema (HAE)

Investigational drug(s) / intervention(s)

navenibartPlacebo

navenibart: Navenibart will be administered as a subcutaneous injection.

Placebo: Placebo will be administered as a subcutaneous injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Documented diagnosis of HAE (Type 1 or 2). The following must be met: 1. Documented clinical history consistent with HAE 2. 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. Exclusion Criteria: * 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). 1. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In 2. Plasma-derived C1INH for LTP within 14 days prior to Run-In 3. Berotralstat within 21 days prior to Run-In 4. Lanadelumab within 70 days prior to Run-In 5. Garadacimab within 90 days prior to Run-In

Primary outcome measure(s)

Trial sites (86)

FacilityCityRegionStatus
Site 9 Birmingham Alabama
Site 2 Scottsdale Arizona
Site 3 Little Rock Arkansas
Site 26 San Diego California
Site 14 San Diego California
Site 4 Santa Monica California
Site 1 Walnut Creek California
Site 8 Centennial Colorado
Site 11 Colorado Springs Colorado
Site 25 Tampa Florida
Site 69 Weston Florida
Site 6 Wheaton Maryland
Site 67 Boston Massachusetts
Site 13 Detroit Michigan
Site 10 St Louis Missouri
Site 7 Cincinnati Ohio
Site 12 Toledo Ohio
Site 15 Hummelstown Pennsylvania
Site 86 Dallas Texas
Site 68 Campbelltown New South Wales
Site 76 Melbourne Victoria
Site 74 Murdoch Australia
Site 83 Vienna Austria
Site 45 Santo André Brazil
Site 28 Sofia Bulgaria
Site 5 Ottawa Ontario
Site 23 Edmonton Canada
Site 37 Hradec Králové Czechia
Site 39 Prague Czechia
Site 46 La Tronche France
Site 54 Lille France
Site 65 Marseille France
Site 72 Nice France
Site 52 Paris France
Site 38 Berlin Germany
Site 44 Frankfurt Germany
Site 70 Hanover Germany
Site 20 Hong Kong Hong Kong
Site 64 Budapest Hungary
Site 55 Ashkelon Israel

+ 46 more sites — see the full list on the official registry below.

More Astria Therapeutics, Inc. trials in the UK

Other trials for the same condition

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 NCT06842823 on ClinicalTrials.gov ↗ ← All trials in the UK