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)
← catalyst calendarNCT07266402 · readout ≤ 681 d
Sponsored by Celldex Therapeutics (industry) · CLDX — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
240estimated
Sites
72
Countries
Germany, Lithuania, Poland +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-01-15 | actual | When the study began enrolling |
| Primary completion | Jun 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Chronic Inducible Urticaria
- Cold Urticaria
- Cold-Induced Urticaria
- Symptomatic Dermographism
Interventions
- Drug: Barzolvolimab — also filed as CDX-0159
- Drug: Matching Placebo
Primary outcome
what the primary-completion date above is the date OFComplete response to provocation testing at Week 12
measured From Day 1 (first dose) to Week 12
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