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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)

Celldex Therapeutics · NCT07266402

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
240
US sites recruiting
25
Study start
January 15, 2026
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Barzolvolimab; Matching Placebo

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key 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
  • Normal blood counts and liver function tests.
  • Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment.
  • Willing and able to complete a daily symptom electronic diary and comply with study visits.
  • Participants with and without prior biologic experience are eligible.

Key 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).
  • Prior treatment with barzolvolimab

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

Recruiting US locations

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham, AL 35244

    Site contact: Jennifer Perry · jperry@cahabaderm.com

  • One of a Kind Clinical Research Center, LLC

    Scottsdale, AZ 85258

    Site contact: Jordan Byers · jordan@1-oak.net

  • Kern Research, Inc.

    Bakersfield, CA 93301

    Site contact: Wandy Noriega · wandy.noriega@kernresearch.com

  • One of a Kind Clinical Research Center

    Napa, CA 94558

    Site contact: Michelle Humbard · michelle@1-oak.net

  • Allergy & Asthma Consultants

    Redwood City, CA 94063

    Site contact: Sherry Lipson · sherry.lipsonallergy@gmail.com

  • Amicis Research Center

    Sherman Oaks, CA 91403

    Site contact: William Calder · w.calder@amicisresearch.com

  • FOMAT - Allergy, Asthma & Immunology Medical Group

    Ventura, CA 93003

    Site contact: Thai Orantes · torantes@fomatmedical.com

  • Direct Helpers Research Center

    Hialeah, FL 33012

    Site contact: Monica Merino-Lopez · monica@dhrtrials.com

  • Well Pharma Medical Research, Corp.

    Miami, FL 33143

    Site contact: Yudesiy Izquierdo · yizquierdo@wpharma.com

  • Deluxe Health Center, LLC

    Miami Lakes, FL 33014

    Site contact: Leidy Caballero · lcaballero@deluxehealthcenter.com

  • GCP, Global Clinical Professionals

    St. Petersburg, FL 33705

    Site contact: Nailis Echevarria · nechevarria@researchgcp.com

  • Advanced Clinical Research Institute

    Tampa, FL 33607

    Site contact: Lisbet Rodriguez · lisbet@acrinstitute.com

  • Centricity Research Columbus Dermatology

    Columbus, GA 31904

    Site contact: Cheyenne Dempsey · cheyenne.dempsey@centricityresearch.com

  • Treasure Valley Medical Research

    Boise, ID 83706

    Site contact: Jackie Allen · jallen@tvmedresearch.com

  • Endeavor Health Clinical Trials Center

    Skokie, IL 60077

    Site contact: Alba Berty · alba.berty@endeavorhealth.org

  • Equity Medical, LLC

    Bowling Green, KY 42104

    Site contact: Kristen Newman · knewman@equity-med.com

  • Advanced ENT and Allergy, PLLC

    Louisville, KY 40207

    Site contact: Rhonda Dase · rdase@advancedentandallergy.com

  • Johns Hopkins University

    Baltimore, MD 21224

    Site contact: Kellie Devine · kdevine1@jhmi.edu

  • Revival Research Institute, LLC

    Troy, MI 48084

    Site contact: Ria Abraham · rabraham@rev-research.com

  • Equity Medical, LLC

    New York, NY 10023

    Site contact: Adugna Deboch · adugna.getahun@primeglobalresearch.com

  • Markowitz Medical PLLC dba OptiSkin Medical

    New York, NY 10128

    Site contact: Nathan Schwab · nathan@optiskinmedical.com

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, OK 73120

    Site contact: Meryem Assaoui · meryem@mtarpay.com

  • Advanced Dermatology and Cosmetic Surgery - Spartanburg

    Spartanburg, SC 29307

    Site contact: Rion Allen · rion.allen@adcsclinics.com

  • RFSA Dermatology

    San Antonio, TX 78212

    Site contact: Jonathan Joseph · jonathanj.rfsadermatology@gmail.com

  • Allergy Associates of Utah

    Sandy City, UT 84093

    Site contact: Holly Anderson · holly.anderson@utahallergies.com

Study contacts (from the official record)

  • Celldex Therapeutics · 844-723-9363 · clinicaltrials@celldex.com
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