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Barzolvolimab versus placebo for adults with cold-induced urticaria and symptomatic dermographism not controlled by H1-antihistamines

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

Phase 3 Interventional Celldex Therapeutics · NCT07266402

This trial will test whether barzolvolimab can reduce hives and itching in adults with cold-induced urticaria or symptomatic dermographism who remain symptomatic despite H1-antihistamines.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorCelldex Therapeutics Industry-sponsored
Drugs / interventionsbarzolvolimab
Locations72 sites (Birmingham, Alabama and 71 other locations)
Trial IDNCT07266402 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled trial enrolling adults with cold-induced urticaria (ColdU) or symptomatic dermographism (SD) who remain symptomatic on stable second-generation H1-antihistamines. After up to 4 weeks of screening, participants are randomized to receive barzolvolimab or placebo during a 24-week double-blind treatment period (initial 450 mg dose then 150 mg every 4 weeks for active arm). Following that, there is a 28-week period in which all participants receive open-label barzolvolimab 300 mg every 8 weeks, and then a 16-week safety follow-up. Efficacy will be compared between randomized arms and safety/tolerability monitored throughout.

Who should consider this trial

Good fit: Adults aged 18 or older with a diagnosis of cold-induced urticaria or symptomatic dermographism for at least 3 months who remain symptomatic despite a stable regimen of second-generation non-sedating H1-antihistamines and meet provocation test thresholds (ColdU: TempTest CTT ≥15 °C and itch NRS ≥5; SD: FricTest CFT ≥3 and itch NRS ≥5).

Not a fit: Patients whose symptoms are well controlled on current antihistamine therapy, who do not meet the provocation test thresholds, who are under 18, or who have contraindications to the study drug are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, barzolvolimab could reduce frequency and severity of hives and itch and provide a new treatment option for patients not helped by H1-antihistamines.

How similar studies have performed: Other biologic therapies such as omalizumab have shown benefit for some forms of urticaria, supporting biologic approaches, but barzolvolimab in ColdU and SD is being tested in larger Phase 3 trials to confirm benefit.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Males and females, \>/= 18 years of age.
2. Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months.
3. 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:

   1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
   3. 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.
   4. 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.
4. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening
5. Normal blood counts and liver function tests.
6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment.
7. Willing and able to complete a daily symptom electronic diary and comply with study visits.
8. Participants with and without prior biologic experience are eligible.

Key Exclusion Criteria:

1. Women who are pregnant or nursing.
2. Clearly defined cause for chronic urticaria.
3. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
4. Medical condition that would cause additional risk or interfere with study procedures.
5. Known HIV, hepatitis B or hepatitis C infection.
6. 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.
7. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).
8. Prior treatment with barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Where this trial is running

Birmingham, Alabama and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Inducible UrticariaCold UrticariaCold-Induced UrticariaSymptomatic DermographismChronic Inducible urticariacold urticariacold-induced urticariaColdU
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.