Trials / Recruiting
RecruitingNCT06842823
A Study of Navenibart in Participants With Hereditary Angioedema
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 145 (estimated)
- Sponsor
- Astria Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | navenibart | Navenibart will be administered as a subcutaneous injection. |
| DRUG | Placebo | Placebo will be administered as a subcutaneous injection. |
Timeline
- Start date
- 2025-03-20
- Primary completion
- 2027-03-01
- Completion
- 2027-09-01
- First posted
- 2025-02-24
- Last updated
- 2026-04-09
Locations
85 sites across 24 countries: United States, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, North Macedonia, Poland, Portugal, Puerto Rico, South Africa, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06842823. Inclusion in this directory is not an endorsement.