Clinical Trial

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

Study acronym: EMBARQ-CSU2
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2024-06-07; most recent amendment 2026-03-24.
Status change: Recruiting → Active, Not Recruiting 2026-02-25
Status change: Not Yet Recruiting → Recruiting 2024-07-23
Trial Details
NCT Number NCT06455202
Lead Sponsor Celldex Therapeutics
Conditions Chronic Spontaneous Urticaria
Enrollment 976 participants
Start Date 2024-07-19
Primary Completion 2026-10 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-25