protocolSection identificationModule nctId: NCT06343779, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Pharvaris Netherlands B.V., class: INDUSTRY, descriptionModule 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., conditionsModule 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, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Deucrictibant, Placebo, outcomesModule primaryOutcomes 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., secondaryOutcomes measure: Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment., secondaryOutcomes 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., secondaryOutcomes measure: Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S)., secondaryOutcomes measure: Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment., secondaryOutcomes measure: Time to End of Progression (EoP) in attack symptoms within 12 hours., secondaryOutcomes measure: Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment., secondaryOutcomes measure: Proportion of attacks achieving symptom resolution., secondaryOutcomes measure: Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA)., secondaryOutcomes measure: Time to almost complete or complete symptom relief by AMRA., secondaryOutcomes measure: Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA., secondaryOutcomes measure: Time to EoP in attack symptoms within 12 hours., eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Study Site, status: RECRUITING, city: Paradise Valley, state: Arizona, zip: 85258, country: United States, geoPoint lat: 33.53115, lon: -111.94265, locations facility: Study Site, status: RECRUITING, city: Walnut Creek, state: California, zip: 94598, country: United States, geoPoint lat: 37.90631, lon: -122.06496, locations facility: Study Site, status: RECRUITING, city: Madison, state: Mississippi, zip: 39110, country: United States, geoPoint lat: 32.46181, lon: -90.11536, hasResults: False