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Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

Study acronym: RAPIDe-2
StatusEnrolling by Invitation
PhasePhase 2/3
Started
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Record History

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  1. Trial sites reduced: 63 → 60 locationsv15
  2. Eligibility criteria expanded, about 38 words
    • Study description expanded, about 15 words
    v14
  3. Enrollment target: 140 to 150v13 Show 5 more changesShow less
    • Interventions: deucrictibant selected dose (Drug) to deucrictibant (Drug), deucrictibant (Drug)
    • Eligibility criteria expanded, about 259 words
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 7 words
    • Study arms: 1 to 2
  4. Study sites: 53 to 63v12
  5. Primary endpoints: 6 to 7
    • Study sites: 21 to 53
    • Eligibility criteria expanded, about 134 words
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Enrollment target: 72 to 140v10 Show 9 more changesShow less
    • Primary and study completion dates: Dec 2024 to Jun 2027
    • Primary endpoints: 4 to 6
    • Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 16 to 21
    • Interventions: deucrictibant high dose (Drug), deucrictibant low dose (Drug), deucrictibant medium dose (Drug), deucrictibant selected dose (Drug) to deucrictibant selected dose (Drug)
    • Eligibility criteria expanded, about 152 words
    • Secondary endpoints: 9 to 7
    • Study description shortened, about 54 words
    • Study arms: 4 to 1
  2. Study sites: 13 to 16
    • Interventions: PHA-022121 high dose (Drug), PHA-022121 low dose (Drug), PHA-022121 medium dose (Drug), PHA-022121 selected dose (Drug) to deucrictibant high dose (Drug), deucrictibant low dose (Drug), deucrictibant medium dose (Drug), deucrictibant selected dose (Drug)
    • Study description revised
    v9
  3. Start date: Jul 19, 2022 to Dec 28, 2022
    • Study sites: 8 to 13
    v8
  4. Study sites: 5 to 8v7
  5. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 3 to 5
    v6
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v5
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Aug 2022 to Jul 19, 2022
    v4
  8. Start date: Jul 2022 to Aug 2022v3
  9. Start date: Jun 2022 to Jul 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks. The study will enroll participants from Study PHA022121-C201 (NCT04618211), Study PHA022121-C306 (NCT06343779) and deucrictibant treatment naïve HAE-nC1INH adult participants who elect to participate in this extension study and meet the eligibility requirements.
Trial Details
NCT Number NCT05396105
Lead Sponsor Pharvaris Netherlands B.V.
Conditions
(from sponsor)		 Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II, Hereditary Angioedema Attack, Hereditary Angioedema With C1 Esterase Inhibitor Deficiency, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2 +9 more
Related terms Angioedemas, Hereditary, Hereditary Angioedema Type III, Hereditary Angioedema Types I and II
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov