D2.349 - RAPIDe‑3 Patient Voices: Qualitative Insights from the Phase 3 Study of Oral Deucrictibant for On-Demand Treatment of Hereditary Angioedema Attacks

Hereditary angioedema (HAE) attacks are caused by excess bradykinin activating bradykinin B2 receptors. Deucrictibant is a potent, selective, orally administered, bradykinin B2 receptor antagonist under development for both prophylactic and on-demand treatment (ODT) of bradykinin-mediated angioedema attacks, including HAE. To date, no qualitative Patient Experience Data have been collected in the setting of phase 3 HAE ODT clinical trials. To address this gap, the phase 3 RAPIDe-3 trial of deucrictibant immediate release (IR) capsule for ODT of HAE attacks was designed to include qualitative interviews to capture information about the patient experience, including fatigue and anxiety associated with angioedema attacks, impact on daily activities, satisfaction of taking deucrictibant, and health status. 

RAPIDe-3 (NCT06343779) was a phase 3, placebo-controlled trial, in which adolescents and adults (≥12 to ≤75 years) with HAE were randomized to self-administer double-blinded oral deucrictibant IR capsule 20 mg or placebo in a crossover design to treat two qualifying HAE attacks. A blinded, open-ended qualitative interview was conducted remotely by an independent third party with participants following each study drug-treated attack. Participants were asked for descriptions of their attacks and associated symptoms, including impairment of daily activities, fatigue, anxiety, and depression associated with attacks as well as their experiences treating an HAE attack with deucrictibant or placebo. 

In RAPIDe-3, the primary analysis set included 88 participants with paired attacks treated with deucrictibant and placebo. Results will include comparisons of treatment with deucrictibant IR capsule or placebo for the time participants took the first dose, the duration and severity of attacks, and the physical and emotional burden of attack symptoms.

Qualitative interviews conducted with participants of the placebo-controlled RAPIDe-3 trial provide further insights into the experiences of individuals living with HAE. Results of the data analyses will shed light on their experiences treating HAE attacks with deucrictibant IR capsule.