At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Deucrictibant (drug)
- How long the study runs
- Study runs about 46 months (dates as stated)
- About the drug or intervention
- Deucrictibant — drug: Deucrictibant extended-release tablet for once daily oral use
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 170
- Started
- 2025-02-01
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for hereditary angioedema (hae)
- • Phase3 - 170 participants
- • This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with hereditary angioedema (hae)
Where?
- • Birmingham - Study Site
- • Birmingham - Study Site
- • Brighton - Study Site
- • Bristol - Study Site
- • +7 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
More detail
The study consists of a Screening Period during which eligibility is confirmed (only for participants not rolling over within 28 days from a previous deucrictibant prophylactic study), a Treatment Period in which participants will receive open-label deucrictibant extended-release tablet once daily for approximately 240 weeks, followed by an End of Study visit after maximum 4 weeks. Participants will undergo regular safety (e.g. lab draws) and efficacy assessments, will complete an electronic diary, and also complete questionnaires at predefined timepoints during the study.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: All genders
What the study is looking for
- ✓Provision of the signed ICF by the participant and/or legally designated representative.
- ✓Male or female, aged ≥12 years at the time of providing written agreement to take part/assent.
- ✓Diagnosis of hereditary angioedema (HAE)
- ✓For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1...
- ✓Reliable access and ability to use the usual treatment on-demand treatments to effectively manage acute HAE attacks.
Who cannot take part
- ✗Any diagnosis of angioedema other than HAE
- ✗Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives...
- ✗Prior gene therapy for any indication at any time
- ✗Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
- ✗Abnormal liver function
See the full criteria
Where Is This Study? (11 UK sites)
Study Site
Birmingham B18 7QH, United Kingdom
Study Site
Birmingham B9 5SS, United Kingdom
Study Site
Brighton, United Kingdom
Study Site
Bristol, United Kingdom
Study Site
Cambridge, United Kingdom
Study Site
Frimley, United Kingdom
Study Site
London E1 1FR, United Kingdom
Study Site
London, United Kingdom
Study Site
Oxford, United Kingdom
Study Site
Plymouth, United Kingdom
Study Site
Southampton, United Kingdom
