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Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 48 sitesv5
  2. Re-verified, no change to tracked fieldsv4
  3. Recruitment opened Trial sites expanded: 0 → 48 locations · Start date changed from estimate of Apr 1, 2026 to Apr 2, 2026v3 Show 2 more changesShow less
    • Trial sites expanded: 0 → 48 locations
    • Start date changed from estimate of Apr 1, 2026 to Apr 2, 2026
  4. Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.
Trial Details
NCT Number NCT07428499
Lead Sponsor ADARx Pharmaceuticals, Inc.
Conditions Hereditary Angioedema (HAE), Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2, HAE
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov