Oral Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks: Results of the Phase 3 RAPIDe-3 Study
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Authors
Riedl M.
Li P.
Adatia A.
Cancian M.
Stobiecki M.
Valerieva A.
Grumach A.
Lumry W.
Soteres D.
Brodszki N.
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2026
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Conference Proceedings
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Rationale: Hereditary angioedema (HAE) attacks are caused by excess bradykinin activating bradykinin B2 receptors. Deucrictibant is a potent, selective, orally administered antagonist of the bradykinin B2 receptor under development for prophylactic and on-demand treatment of bradykinin-mediated angioedema attacks. RAPIDe-3 is a Phase 3 trial evaluating the efficacy and safety of oral deucrictibant immediate-release (IR) capsule for on-demand treatment of HAE attacks. Method(s): RAPIDe-3 (NCT06343779) is a randomized, double-blind placebo-controlled trial in adolescent and adult participants (>=12-<=75 years old) with HAE. Participants on long-term HAE prophylaxis are also enrolled. Participants self-administer deucrictibant IR capsule 20 mg or placebo, in a crossover fashion, to treat two qualified attacks including non-severe laryngeal attacks without breathing difficulties. Result(s): Target enrolment of participants (N=120) was achieved. The primary endpoint is time to onset of symptom relief, defined as a Patient Global Impression of Change (PGI-C) rating of at least "a little better" for two consecutive timepoints within 12 hours post-treatment. Secondary endpoints include proportion of attacks achieving onset of symptom relief, and time to substantial symptom relief, reduction in attack severity, complete attack resolution, and end of progression of attack symptoms. Other secondary endpoints are rescue medication use and the proportion of attacks achieving complete attack resolution (including with a single dose). Safety outcomes include treatment-emergent adverse events (TEAEs) and serious TEAEs. Conclusion(s): RAPIDe-3 evaluates the efficacy and safety of oral deucrictibant IR capsule for treatment of HAE attacks in adolescents and adults. Top-line data are anticipated in 4Q2025 and will be presented. Copyright © 2025 Elsevier Inc.
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The Journal of Allergy and Clinical Immunology
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Programs and Abstracts of Papers to be Presented During Scientific Sessions: 2026 AAAAI Annual Meeting.