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 States, Germany, Lithuania240 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete response to provocation testing at Week 12
. 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.
. 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).