CHAPTER 3
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release Tablet for Prophylaxis against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema (CHAPTER-3)
IRAS ID
1010653
Contact name
Kathryn Hutchinson
Contact email
Sponsor organisation
AMS Advanced Medical Services Limited
Eudract number
2024-516247-62
Research summary
This is a study to test the efficacy and safety of Deucrictibant compared to placebo in in preventing attacks of hereditary angioedema (HAE) in patients aged >12 years. the study is being conducted at approximately 80 sites in North America and Europe. The study will include patients who have HAE Type I or II and are not taking long-term treatments to prevent HAE attacks. Patients will be randomised to either placebo or 40 mg Deucrictibant (in a 1:2 ratio) for 24 weeks. Study treatment will be taken orally, once a day. Deucrictibbant is a bradykinin B2 receptor antagonist. The primary objective is to assess the decrease or total absence of HAE attacks, over the treatment period. The attacks will be reported by patients, and then confirmed by study doctors at the individual sites. Patients will keep a daily electronic diary to report their HAE attacks. Safety will be assessed by vital signs, safety blood and urine tests and ECG assessments across the 24 weeks. Total duration of the trial, for an individual, is up to 38 weeks, including a screening and a follow-up period. Following completion of the 24 weeks study treatment, patients will be offered an open label clinical trial, if they wish to receive Deucrictibant for a further 130 weeks.
REC name
Wales REC 3
REC reference
24/WA/0313
Date of REC Opinion
7 Nov 2024
REC opinion
Further Information Favourable Opinion