Astria STAR-0215-301 trial for Navenibart in Hereditary Angioedema
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema – ALPHA-ORBIT
IRAS ID
1011684
Contact name
Clinical Trial Inquiries
Contact email
Sponsor organisation
Astria Therapeutics, Inc
Eudract number
2024-520144-41
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for new ways to manage hereditary angioedema (HAE). HAE is a rare disorder that causes repeated and unpredictable attacks of swelling in the face, arms and legs, abdomen, genitals, and airway. These attacks can be severe, painful, disabling, and life-threatening. Treatments for HAE include medicines that help lessen the severity of an attack as it is happening (on-demand treatment). There are also medicines that help prevent HAE attacks (preventative treatment). These medicines often need frequent dosing, which can be a burden for patients.
The drug being studied in this trial is called navenibart. Navenibart is a monoclonal antibody (an antibody is part of the body’s immune defense system). It is being developed to prevent HAE attacks. It does this by blocking plasma kallikrein, an enzyme that produces a substance called bradykinin, which causes HAE attacks. Early data suggests that navenibart can potentially help patients by preventing HAE attacks. Astria Therapeutics Inc., the company that makes navenibart, wants to find out more about its effects in patients with HAE, both adults (18 years or older) and adolescents (12 to 17 years old). Navenibart is being developed as a potential long-acting treatment administered as an injection every 3 or 6 months.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0058
Date of REC Opinion
29 Apr 2025
REC opinion
Further Information Favourable Opinion