Astria STAR-0251-302 trial for Navenibart in Hereditary Angioedema
Research type
Research Study
Full title
A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE
IRAS ID
1012485
Contact name
Clinical Trial Inquiries
Contact email
Sponsor organisation
Astria Therapeutics, Inc
Eudract number
2025-521142-22
ISRCTN Number
ISRCTN10574179
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 to be taken frequently, which can be a burden for patients.
The drug being studied in this trial is called navenibart. Navenibart is a monoclonal antibody made in a laboratory (a natural 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 results suggest 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).REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0762
Date of REC Opinion
9 Dec 2025
REC opinion
Further Information Favourable Opinion