RAPIDe-3

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema

• IRAS ID

  1008671

• Contact name

  Eivind Omli

• Contact email

  clinical@pharvaris.com

• Sponsor organisation

  Pharvaris Netherlands B.V.

• Clinicaltrials.gov Identifier

  NCT06343779

• Research summary

  This is a randomised, double-blind, placebo-controlled, 2-period, 2 treatment cross-over study in participants with HAE.

  All participants are planned to treat 2 HAE attacks with study drug during the study. One attack will be treated with deucrictibant and the other will be treated with placebo, the order of which will be decided randomly (like flipping a coin) up front. “Double-blind” means that neither the participant nor study doctor knows whether the participant is receiving deucrictibant or placebo for a given attack. A total of approximately 120 people with HAE are planned to participate.
  Either non-severe laryngeal HAE attacks (ie, larygneal attacks with no symptoms of where difficulty breathing and/or stridor) and non-laryngeal HAE attacks (ie, attacks involving areas other than the throat) may be treated.
  The duration of participation in the study depends on the time needed to experience 2 qualifying attacks (ie, confirmed by the study doctor) treated with study drug. The average duration is estimated to be approximately 42 weeks (~10 months) for each participant (but actual duration may vary from 1.5 to more than 14 months).

  The main goal of this study is to assess the efficacy of deucrictibant in participants with HAE. The main trial endpoint (outcome) is the time it takes to feel relief from the symptoms of an HAE attack, as measured using a questionnaire (called the PGI-C), which will be completed by the participant using a handheld electronic device (eg, mobile device).

  Deucrictibant has been shown to reduce HAE attack duration and severity in HAE patients, with no notable side effects. Data from studies in humans are supported by those from animal studies. Thus, the potential benefit of treatment is believed to outweigh any potential risks with deucrictibant for “on-demand” treatment of HAE attacks in this study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  24/LO/0353

• Date of REC Opinion

  11 Jun 2024

• REC opinion

  Further Information Favourable Opinion