nctId: NCT06343779 id: PHA022121-C306 briefTitle: Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema acronym: RAPIDe-3 overallStatus: RECRUITING date: 2024-02-26 date: 2026-03 date: 2026-03 date: 2024-04-03 date: 2024-04-03 name: Pharvaris Netherlands B.V. class: INDUSTRY briefSummary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1 or type 2 (HAE-1/2), a proportion of whom are using long-term prophylactic medication for HAE. conditions: Hereditary Angioedema conditions: Hereditary Angioedema Type I conditions: Hereditary Angioedema Type II conditions: Hereditary Angioedema Types I and II conditions: Hereditary Angioedema Attack conditions: Hereditary Angioedema With C1 Esterase Inhibitor Deficiency conditions: Hereditary Angioedema - Type 1 conditions: Hereditary Angioedema - Type 2 conditions: C1 Esterase Inhibitor [C1-INH] Deficiency conditions: C1 Esterase Inhibitor Deficiency conditions: C1 Esterase Inhibitor, Deficiency of conditions: C1 Inhibitor Deficiency studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Deucrictibant, Placebo measure: Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment. measure: Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment. measure: Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment. measure: Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S). measure: Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment. measure: Time to End of Progression (EoP) in attack symptoms within 12 hours. measure: Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment. measure: Proportion of attacks achieving symptom resolution. measure: Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA). measure: Time to almost complete or complete symptom relief by AMRA. measure: Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA. measure: Time to EoP in attack symptoms within 12 hours. sex: ALL minimumAge: 12 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Study Site status: RECRUITING city: Paradise Valley state: Arizona zip: 85258 country: United States lat: 33.53115 lon: -111.94265 facility: Study Site status: RECRUITING city: Walnut Creek state: California zip: 94598 country: United States lat: 37.90631 lon: -122.06496 facility: Study Site status: RECRUITING city: Madison state: Mississippi zip: 39110 country: United States lat: 32.46181 lon: -90.11536 hasResults: False