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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Study acronym: EMBARQ-CSU1
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv20
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 915 to confirmed 963
    • Study sites: 245 to 235
    v19
  3. Secondary endpoints: 10 to 8
    • Study sites revised (245)
    v18
  4. Study sites: 237 to 245v17
  5. Study sites: 230 to 237v16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 223 to 230v15
  2. Study sites: 220 to 223v14
  3. Study sites: 196 to 220v13
  4. Study sites: 184 to 196v12
  5. Eligibility criteria expanded, about 6 wordsv11
  6. Study sites: 140 to 184
    • Eligibility criteria revised
    v10
  7. Study sites: 70 to 140v9
  8. Study sites: 46 to 70v8
  9. Study sites: 41 to 46v7
  10. Study sites: 35 to 41v6
  11. Study sites: 20 to 35v5
  12. Study sites: 9 to 20
    • Start date changed from estimate of Jul 2024 to Jul 11, 2024
    v4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 9
    v3
  14. Study title shortened, about 1 wordv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Trial Details
NCT Number NCT06445023
Lead Sponsor Celldex Therapeutics
Conditions
(from sponsor)		 Chronic Spontaneous Urticaria
Related terms Chronic Urticaria
Enrollment 963 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov