NCT07266402Phase 3Recruiting

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)

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-06Estimated

Enrollment · participants240Estimated

Source updated2026-08-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-12-15 · 1 field changed

Recruitment status changed

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~~Not yet recruiting~~

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Recruiting

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Study details

Conditions studied

Chronic Inducible Urticaria; Cold Urticaria; Cold-Induced Urticaria; Symptomatic Dermographism

Treatments or interventions studied

BarzolvolimabDrugAlso known as CDX-0159
Matching PlaceboDrug

Primary outcomes · main study measures

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measure: Complete response to provocation testing at Week 12; description: Proportion of Cold Induced Urticaria \[ColdU\] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism \[SD\] participants with complete response in Critical Friction Threshold at Week 12. * For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a complete response test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®; timeFrame: From Day 1 (first dose) to Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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