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A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 8 of 15 entries
    • Study sites revised (72)
  2. Site details revised at 2 of 72 sitesv12
  3. Study sites: 73 to 72v11
  4. Study sites revised (73)v10
  5. Study sites: 72 to 73v9
Show 7 earlier versionsHide 7 earlier versions
  1. Secondary endpoints: 16 to 15
    • Study description expanded, about 20 words
    • Study sites revised (72)
    • Eligibility criteria expanded, about 4 words
    v8
  2. Site details revised at 1 of 72 sitesv7
  3. Site details revised at 15 of 72 sitesv6
  4. Start date: Dec 5, 2025 to Jan 15, 2026
    • Site details revised at 5 of 72 sites
    v5
  5. Study sites: 73 to 72v4
  6. Re-verified, no change to tracked fieldsv3
  7. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 73
    • Start date changed from estimate of Dec 2025 to Dec 5, 2025
    • Secondary endpoints: details revised at 5 of 16 entries
    • Study title expanded, about 17 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
Trial Details
NCT Number NCT07266402
Lead Sponsor Celldex Therapeutics
Conditions
(from sponsor)		 Chronic Inducible Urticaria, Cold Urticaria, Cold-Induced Urticaria, Symptomatic Dermographism
Related terms Chronic Inducible Urticaria, Cold Urticaria, Familial dermographism
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov