A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adult… (NCT07266402) | Clinical Trial Compass
RecruitingPhase 3
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)
United States240 participantsStarted 2026-01-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females, \>/= 18 years of age.
✓. Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months.
✓. Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
✓. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
✓. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
✓. Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and \< 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.
✓. Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.
✓. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening
Exclusion criteria
✕. Women who are pregnant or nursing.
✕. Clearly defined cause for chronic urticaria.
✕. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
What they're measuring
1
Complete response to provocation testing at Week 12
. Medical condition that would cause additional risk or interfere with study procedures.
✕. Known HIV, hepatitis B or hepatitis C infection.
✕. Vaccination with a live vaccine within 30 days prior to screening (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
✕. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).