Deucrictibant for Hereditary Angioedema
(RAPIDe-2 Trial)

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen byMarcus Maurer, Prof MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Pharvaris Netherlands B.V.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks, in participants with HAE type 1 or type 2 (HAE-1/2). The study will enroll patients from Study PHA022121-C201 (NCT04618211) and Study PHA022121-C306 (NCT06343779) who elect to participate in this extension study and meet the eligibility requirements.

Eligibility Criteria

This trial is for patients with Hereditary Angioedema (HAE) due to C1-INH deficiency who have taken at least one dose of the study drug in a previous related trial. Participants must not be pregnant, breastfeeding, or have any condition that could affect their safety or participation. They also shouldn't be on certain other HAE treatments or drugs affecting liver enzymes.

Inclusion Criteria

Must have received at least 1 dose of study drug (including the non-attack visit) in Study PHA022121-C201.

I have been diagnosed with Hereditary Angioedema type I or II.

Signed and dated informed consent form

Exclusion Criteria

I do not have any health conditions that would make it unsafe for me to join the study.

You have a heart problem that shows up on a special heart test.

Pregnancy or breast-feeding

+5 more

Participant Groups

The study tests long-term use of deucrictibant at various doses for treating sudden HAE attacks. It's an extension from a prior study and focuses on oral administration effectiveness and safety over time, including its impact on severe throat swelling attacks.

1Treatment groups

Experimental Treatment

Group I: Part B: Selected doseExperimental Treatment1 Intervention

Single dose of deucrictibant