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Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

StatusEnrolling by Invitation
PhasePhase 3
Started
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Record History

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  1. Trial sites expanded: 131 → 182 locations
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 9 of 29 entries
  2. Trial sites expanded: 96 → 131 locationsv12
  3. Trial sites expanded: 63 → 96 locationsv11
  4. Trial sites expanded: 34 → 63 locationsv10
  5. Trial status changed: Recruiting → Enrolling by Invitation
    • Study sites revised (34)
    v9
  6. Trial sites expanded: 20 → 34 locationsv8
  7. Trial sites expanded: 15 → 20 locationsv7
  8. Trial sites expanded: 9 → 15 locationsv6
  9. Eligibility criteria shortened, about 15 wordsv5
  10. Study sites: 2 to 9v4
  11. Study sites: 1 to 2v3
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2025 to Nov 25, 2025
    v2
  13. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
Trial Details
NCT Number NCT07256392
Lead Sponsor Celldex Therapeutics
Conditions
(from sponsor)		 Chronic Spontaneous Urticaria
Related terms Chronic Urticaria
Enrollment 1,370 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov