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) (EMBARQ)

May 6, 2026 updated by: Celldex Therapeutics

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (ColdU) or symptomatic dermographism (SD) who remain symptomatic despite the use of H1-antihistamines.

There is a Screening Period of up to 4 weeks, followed by a 24-week treatment period where patients will receive barzolvolimab or placebo. Patients receiving barzolvolimab will receive 450mg at the start of the treatment period and then 150mg every 4 weeks. Then there is a 28-week treatment period where all patients will receive 300mg barzolvolimab every 8 weeks, followed by a 16-week follow-up period where all patients are observed.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Augsburg, Germany
        • Not yet recruiting
        • Universitätsklinikum Augsburg - III. Med. Klinik
      • Berlin, Germany
        • Not yet recruiting
        • Institut für Allergieforschung (IFA) Charité - Universitätsmedizin Berlin
      • Buxtehude, Germany
      • Darmstadt, Germany
      • Dresden, Germany
        • Not yet recruiting
        • University Hospital Dresden
      • Düsseldorf, Germany
        • Not yet recruiting
        • University Hospital Düsseldorf
      • Erlangen, Germany
        • Not yet recruiting
        • Universitatsklinkum Erlangen-Ulmenweg 18
      • Göttingen, Germany
        • Not yet recruiting
        • Universitätsklinikum Göttingen
      • Heidelberg, Germany
        • Not yet recruiting
        • Universitätsklinikum Heidelberg
      • Kiel, Germany
        • Not yet recruiting
        • MVZ DermaKiel GmbH
      • Lübeck, Germany
        • Recruiting
        • Universitatsklinikum Schleswig-Holstein - Campus Lubeck
        • Contact:
        • Principal Investigator:
          • Tomasz Hawro
      • München, Germany
        • Not yet recruiting
        • LMU Klinikum der Universität
      • Münster, Germany
        • Recruiting
        • Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie
        • Contact:
        • Principal Investigator:
          • Andrea Bauer
      • Tübingen, Germany
  • Lithuania
      • Kaunas, Lithuania
        • Recruiting
        • CD8 Klinika
        • Principal Investigator:
          • Jurate Staikuniene-Kozonis
        • Contact:
      • Kaunas, Lithuania
        • Recruiting
        • UAB Ausros Medicinos Centras
        • Principal Investigator:
          • Edita Gasiuniene
      • Klaipėda, Lithuania
        • Not yet recruiting
        • Republic Klaipeda Hospital
      • Vilnius, Lithuania
        • Recruiting
        • Santaros KTC (klinikiniu tyrimu centras)
        • Contact:
        • Principal Investigator:
          • Laura Malinauskiene
      • Vilnius, Lithuania
        • Recruiting
        • UAB Alerginių susirgimų diagnostikos ir gydymo centras
        • Contact:
        • Principal Investigator:
          • Tomas Slomskis
  • Poland
      • Krakow, Poland
        • Not yet recruiting
        • Centrum Medyczne ALL-MED Badania Kliniczne
      • Krakow, Poland
        • Recruiting
        • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
        • Contact:
        • Principal Investigator:
          • Małgorzata Dyczek
      • Lodz, Poland
        • Not yet recruiting
        • "Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi"
      • Lodz, Poland
      • Lublin, Poland
        • Not yet recruiting
        • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska
      • Opole, Poland
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny w Opolu
      • Oświęcim, Poland
        • Recruiting
        • Medicome Sp. z o.o.
        • Principal Investigator:
          • Iwona Kobielusz-Gembala
        • Contact:
      • Poznan, Poland
        • Not yet recruiting
        • EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
      • Rzeszów, Poland
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
      • Tarnów, Poland
        • Not yet recruiting
        • Alergo-med Ośrodek Badań Klinicznych Spólka z ograniczoną odpowiedzialnością
      • Torun, Poland
        • Not yet recruiting
        • MICS Centrum Medyczne Torun
      • Warsaw, Poland
      • Wroclaw, Poland
        • Recruiting
        • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Sp. Partnerska
        • Principal Investigator:
          • Jacek Szepietowski
        • Contact:
  • South Africa
      • Benoni, South Africa
        • Not yet recruiting
        • Worthwhile Clinical Trials
      • Cape Town, South Africa
        • Recruiting
        • Allergy and Immunology Unit, University of Cape Town Lung Institute (UCTLI)
        • Principal Investigator:
          • Jonathan Peter
        • Contact:
      • Durban, South Africa
        • Recruiting
        • Infinity Dermatology Inc
        • Contact:
        • Principal Investigator:
          • Ameshin Moodley
      • Durban, South Africa
      • Durban, South Africa
        • Recruiting
        • Synapta Clinical Research Centre
        • Principal Investigator:
          • Farzana Hoosen
        • Contact:
      • Johannesburg, South Africa
        • Recruiting
        • Newtown Clinical Research Centre
        • Principal Investigator:
          • Fatima Mitha
      • Johannesburg, South Africa
        • Recruiting
        • Sandton Medical Research Centre
        • Principal Investigator:
          • Safiyya Chohan
      • Pretoria, South Africa
        • Recruiting
        • Global Clinical Trials (Pty) Ltd
        • Principal Investigator:
          • Larisha Pillay-Ramaya
        • Contact:
      • Westville, South Africa
        • Recruiting
        • Allergy and Asthma Centre
        • Contact:
        • Principal Investigator:
          • Ahmed Manjra
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
        • Principal Investigator:
          • Ana Gimenez-Arnau
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad Navarra - Pamplona
        • Principal Investigator:
          • Marta Ferrer Puga
        • Contact:
  • United Kingdom
      • Cambridge, United Kingdom
        • Not yet recruiting
        • Addenbrooke's Hospital
      • Glasgow, United Kingdom
        • Not yet recruiting
        • Queen Elizabeth University Hospital
      • Manchester, United Kingdom
        • Not yet recruiting
        • Salford Care Organisation NCA NHS Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Cahaba Dermatology & Skin Health Center, LLC
        • Contact:
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • One of a Kind Clinical Research Center, LLC
        • Contact:
    • California
      • Bakersfield, California, United States, 93301
      • Napa, California, United States, 94558
        • Recruiting
        • One of a Kind Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Genevieve Egnatios
      • Redwood City, California, United States, 94063
      • Sherman Oaks, California, United States, 91403
      • Ventura, California, United States, 93003
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Direct Helpers Research Center
        • Contact:
      • Miami, Florida, United States, 33143
      • Miami Lakes, Florida, United States, 33014
      • St. Petersburg, Florida, United States, 33705
      • Tampa, Florida, United States, 33607
    • Georgia
    • Idaho
      • Boise, Idaho, United States, 83706
    • Illinois
      • Skokie, Illinois, United States, 60077
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
      • Louisville, Kentucky, United States, 40207
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Sarbjit Saini
    • Michigan
      • Troy, Michigan, United States, 48084
    • New York
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Not yet recruiting
        • University of Cincinnati
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Allergy, Asthma & Clinical Research Center
        • Contact:
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
    • Texas
    • Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: barzolvolimab in patients with Cold Induced Urticaria
barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Barzolvolimab
Subcutaneous Administration
Other Names:
  • CDX-0159
Placebo Comparator: Placebo in patients with Cold Induced Urticaria
Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Matching Placebo
Subcutaneous Administration
Experimental: barzolvolimab in patients with Symptomatic Dermographism
barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Barzolvolimab
Subcutaneous Administration
Other Names:
  • CDX-0159
Placebo Comparator: Placebo in patients with Symptomatic Dermographism
Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.
Drug: Matching Placebo
Subcutaneous Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response to provocation testing at Week 12
Time Frame: From Day 1 (first dose) to Week 12

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®
From Day 1 (first dose) to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Critical Temperature Threshold (CTT) at Week 12
Time Frame: From Day 1 (first dose) to Week 12

For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 12.

CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute mark.
From Day 1 (first dose) to Week 12
Change from baseline in Critical Friction Threshold (CFT) at Week 12
Time Frame: From Day 1 (first dose) to Week 12

For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 12.

CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute mark.
From Day 1 (first dose) to Week 12
Complete response to provocation testing at Week 24 for Cold Induced Urticaria participants
Time Frame: From Day 1 (first dose) to Week 24
Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 24
Time Frame: From Day 1 (first dose) to Week 24
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 24.
From Day 1 (first dose) to Week 24
Change from baseline in Critical Friction Threshold (CFT) at Week 24
Time Frame: From Day 1 (first dose) to Week 24
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 24.
From Day 1 (first dose) to Week 24
Complete response to provocation testing at Week 4
Time Frame: From Day 1 (first dose) to Week 4
Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 4 or proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 4
From Day 1 (first dose) to Week 4
Change from baseline in Critical Temperature Threshold (CTT) at Week 4
Time Frame: From Day 1 (first dose) to Week 4
For participants with Cold Induced Urticaria, change from baseline in CTT following the TempTest® at Week 4.
From Day 1 (first dose) to Week 4
Change from baseline in Critical Friction Threshold (CFT) at Week 4
Time Frame: From Day 1 (first dose) to Week 4
For participants with Symptomatic Dermographism, change from baseline in CFT following the FricTest® at Week 4.
From Day 1 (first dose) to Week 4
Improvement in Dermatology Quality of Life Index (DLQI) at Week 12
Time Frame: From Day 1 (first dose) to Week 12
Proportion of participants with DLQI = 0-1 at Week 12.
From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of itch at Week 12
Time Frame: From Day 1 (first dose) to Week 12
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of itch at Week 24
Time Frame: From Day 1 (first dose) to Week 24
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of hives at Week 12
Time Frame: From Day 1 (first dose) to Week 12
Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
From Day 1 (first dose) to Week 12
Improvement in clinical symptoms of hives at Week 24
Time Frame: From Day 1 (first dose) to Week 24
Change from baseline in worst hives-numerical rating scale (WH-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
From Day 1 (first dose) to Week 24
Complete response to provocation testing at Week 24 for Symptomatic Dermographism
Time Frame: From Day 1 (first dose) to Week 24
Proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 24. Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
From Day 1 (first dose) to Week 24
Improvement in clinical symptoms of itch following provocation testing (WI-NRSprovo) at Week 12
Time Frame: From Day 1 (first dose) to Week 12
Change from baseline in WI-NRSprovo at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
From Day 1 (first dose) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX0159-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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