Deucrictibant for Angioedema
(CHAPTER-3 Trial)
Trial Summary
Will I have to stop taking my current medications?
You may need to stop taking certain medications before joining the trial. Specifically, you cannot use ACE inhibitors, estrogen-containing medications, or certain HAE treatments close to the screening period. Check with the trial team to see if your current medications are affected.
What data supports the effectiveness of the drug Deucrictibant for treating angioedema?
Research on a similar drug, Icatibant, shows it effectively reduces the time to resolve angioedema attacks, especially those related to certain blood pressure medications, from about 2 days to 10 hours. This suggests that drugs targeting bradykinin (a protein involved in inflammation) can be effective for angioedema.12345
What is the purpose of this trial?
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.
Research Team
Study Director, Pharvaris
Principal Investigator
Pharvaris Netherlands B.V.
Eligibility Criteria
This trial is for adolescents and adults aged 12 years or older with hereditary angioedema (HAE), who have had at least three HAE attacks in the past three months. Participants must be able to manage acute HAE attacks, follow protocol requirements, and use contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive once-daily orally administered deucrictibant extended-release tablet or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may roll over into the open-label study PHA022121-C307 (CHAPTER-4)
Treatment Details
Interventions
- Deucrictibant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pharvaris Netherlands B.V.
Lead Sponsor