RAPIDe-2
Research type
Research Study
Full title
A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema
IRAS ID
1005340
Contact name
Justin Sun
Contact email
Sponsor organisation
Pharvaris Netherlands BV
Eudract number
2023-505766-28
Clinicaltrials.gov Identifier
Research summary
Deucrictibant has shown promising results when compared to placebo for the treatment of HAE attacks. In clinical studies, deucrictibant has been well tolerated, with no severe side effects considered by the study doctors to be related to it. Pharvaris is conducting a long-term extension study for those who previously participated in a Pharvaris-sponsored deucrictibant clinical study to further evaluate the safety and efficacy of deucrictibant for on-demand treatment of acute HAE attacks in patients with HAE due to C1-INH deficiency (Type 1/2 HAE). The main goal of this study is to assess the safety and efficacy of open-label deucrictibant in participants with HAE who participated in another Pharvaris-sponsored clinical study. About 140 people with HAE are planned to participate. Either laryngeal HAE attacks (ie, attacks involving the throat, but without breathing difficulties) and non-laryngeal HAE attacks may be treated with deucrictibant. All participants are to contact the Investigator within 72 hours after the first deucrictibant dose for each attack to report the attack and collect relevant attack and safety information.
The duration of participation in the study depends on the time of enrolment. The study is intended to continue until deucrictibant is available for sale, all participants have discontinued from the study, or the study is terminated by the sponsor.
Trial population: Males and females aged ≥12 years with HAE due to C1-INH deficiency (type I/II) who have participated in Pharvaris-sponsored study C201 (RAPIDe-1) or C306 (RAPIDe-3) are planned to participate. The study is planned to be conducted in about 80 study sites globally, in approximately 30 countries. Investigational Medicinal Product Used: Participants will take deucrictibant 20 mg soft capsules by mouth. For an unresolving HAE attack, participants may take a second dose of study drug and/or may use their normal HAE medication at any time they feel necessary to treat an HAE attack.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0071
Date of REC Opinion
1 Aug 2024
REC opinion
Further Information Favourable Opinion