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Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

Study acronym: CREAATE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 3 → 9 primary endpoints
See other at-risk trials from Pharvaris Netherlands B.V.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Enrollment increased: 32 → 48 participants
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: 13 to 36
    • Study description revised
    • Study title revised
  2. Re-verified, no change to tracked fieldsv5
  3. Trial sites expanded: 17 → 32 locationsv4
  4. Trial sites expanded: 7 → 17 locationsv3
  5. Study sites: 2 to 7
    • Secondary endpoints: details revised at 3 of 13 entries
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant soft capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
Trial Details
NCT Number NCT07266805
Lead Sponsor Pharvaris Netherlands B.V.
Conditions
(from sponsor)		 Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)
Related terms Acquired angioedema, Angioedema, Angioedemas, Hereditary
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov