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

Study acronym: EMBARQ-CSU2
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 252 to 245v20
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 915 to confirmed 976
    • Study sites: 260 to 252
    v19
  3. Secondary endpoints: 10 to 8
    • Site details revised at 2 of 260 sites
    v18
  4. Study sites: 255 to 260v17
  5. Study sites: 241 to 255v16
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 220 to 241v15
  2. Study sites: 211 to 220v14
  3. Study sites: 198 to 211v13
  4. Study sites: 183 to 198v12
  5. Study sites: 150 to 183v11
  6. Study sites: 81 to 150v10
  7. Eligibility criteria expanded, about 6 wordsv9
  8. Study sites: 64 to 81v8
  9. Study sites: 46 to 64v7
  10. Study sites: 28 to 46v6
  11. Study sites: 23 to 28v5
  12. Study sites: 12 to 23v4
  13. Primary completion date: Oct 2025 to Oct 2026
    • Study sites: 5 to 12
    • Start date changed from estimate of Jul 2024 to Jul 19, 2024
    v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 NCT06455202
Lead Sponsor Celldex Therapeutics
Conditions
(from sponsor)		 Chronic Spontaneous Urticaria
Related terms Chronic Urticaria
Enrollment 976 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov