A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)
Astria Therapeutics, Inc.
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
- Age range
- 12+ years
- Sex
- All
- 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 urti…
Interventions
- Drugnavenibart
Navenibart will be administered as a subcutaneous injection.
- DrugPlacebo
Placebo will be administered as a subcutaneous injection.
Locations (87)
- Site 9Birmingham, Alabama
- Site 2Scottsdale, Arizona
- Site 3Little Rock, Arkansas
- Site 26San Diego, California
- Site 14San Diego, California
- Site 4Santa Monica, California