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)

NCT07266402 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CDX0159-16
• Study Type: interventional
• Target: 240
• Locations: 7 countries
• Sites: 72

Brief 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.

Conditions

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

Keywords

Chronic Inducible urticaria; cold urticaria; cold-induced urticaria; ColdU; symptomatic dermographism,; SD; barzolvolimab; CDX0159; CDX-0159

Outcome Measures

Primary Outcomes (1)

• Complete response to provocation testing at 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 Outcomes (15)

• Complete response to provocation testing at Week 24 for Cold Induced Urticaria participants

  From Day 1 (first dose) to Week 24

• Complete response to provocation testing at Week 24 for Symptomatic Dermographism

  From Day 1 (first dose) to Week 24

• Improvement in clinical symptoms of itch at Week 12

  From Day 1 (first dose) to Week 12

• Improvement in clinical symptoms of itch 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

  From Day 1 (first dose) to Week 12

Study Arms (4)

barzolvolimab in patients with Cold Induced Urticaria

EXPERIMENTAL

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

Placebo in patients with Cold Induced Urticaria

PLACEBO COMPARATOR

Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.

Drug: Matching Placebo

barzolvolimab in patients with Symptomatic Dermographism

EXPERIMENTAL

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

Placebo in patients with Symptomatic Dermographism

PLACEBO COMPARATOR

Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks.

Drug: Matching Placebo

Interventions

Barzolvolimab DRUG

Subcutaneous Administration

Also known as: CDX-0159

barzolvolimab in patients with Cold Induced Urticaria; barzolvolimab in patients with Symptomatic Dermographism

Matching Placebo DRUG

Subcutaneous Administration

Placebo in patients with Cold Induced Urticaria; Placebo in patients with Symptomatic Dermographism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (72)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, 35244, United States

RECRUITING

One of a Kind Clinical Research Center, LLC

Scottsdale, Arizona, 85258, United States

RECRUITING

Kern Research, Inc.

Bakersfield, California, 93301, United States

RECRUITING

One of a Kind Clinical Research Center

Napa, California, 94558, United States

RECRUITING

Allergy & Asthma Consultants

Redwood City, California, 94063, United States

RECRUITING

Amicis Research Center

Sherman Oaks, California, 91403, United States

RECRUITING

FOMAT - Allergy, Asthma & Immunology Medical Group

Ventura, California, 93003, United States

RECRUITING

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

RECRUITING

Well Pharma Medical Research, Corp.

Miami, Florida, 33143, United States

RECRUITING

Deluxe Health Center, LLC

Miami Lakes, Florida, 33014, United States

RECRUITING

GCP, Global Clinical Professionals

St. Petersburg, Florida, 33705, United States

RECRUITING

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

RECRUITING

Centricity Research Columbus Dermatology

Columbus, Georgia, 31904, United States

RECRUITING

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

RECRUITING

Endeavor Health Clinical Trials Center

Skokie, Illinois, 60077, United States

RECRUITING

Equity Medical, LLC

Bowling Green, Kentucky, 42104, United States

RECRUITING

Advanced ENT and Allergy, PLLC

Louisville, Kentucky, 40207, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21224, United States

RECRUITING

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

RECRUITING

Equity Medical, LLC

New York, New York, 10023, United States

RECRUITING

Markowitz Medical PLLC dba OptiSkin Medical

New York, New York, 10128, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

NOT YET RECRUITING

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

RECRUITING

Advanced Dermatology and Cosmetic Surgery - Spartanburg

Spartanburg, South Carolina, 29307, United States

RECRUITING

RFSA Dermatology

San Antonio, Texas, 78212, United States

RECRUITING

Allergy Associates of Utah

Sandy City, Utah, 84093, United States

RECRUITING

Universitätsklinikum Augsburg, Klinik für Dermatologie und Allergologie

Augsburg, Germany

RECRUITING

Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP Immunologie und Allergologie IA c/o Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Elbe Kliniken Buxtehude Dermatologie

Buxtehude, Germany

RECRUITING

Rosenpark Research GmbH

Darmstadt, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Dermatologie

Dresden, Germany

RECRUITING

Department of Dermatology, University Hospital Dusseldorf

Düsseldorf, Germany

RECRUITING

Hautklinik, Uniklinkum Erlangen

Erlangen, Germany

NOT YET RECRUITING

Universitätsklinikum Göttingen -- George-August-Universitat Göttinggen, Klinik für Dermatoogie, Venerologie und Allergologie

Göttingen, Germany

RECRUITING

Universitätsklinikum Heidelberg, Klinik für Dermatologie

Heidelberg, Germany

NOT YET RECRUITING

MVZ DermaKiel GmbH

Kiel, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein Universität zu Lübeck - Campus Lübeck

Lübeck, Germany

RECRUITING

Klinik und Poliklinik für Dermatologie und Allergologie, LMU Klinikum; DASZ-Dermato-Allergologisches Studienzentrum

München, Germany

RECRUITING

Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie

Münster, Germany

RECRUITING

Universitäts-Hautklinik Tübingen Studienzentrum Immundermatologie

Tübingen, Germany

RECRUITING

CD8 Klinika

Kaunas, Lithuania

RECRUITING

UAB Ausros Medicinos Centras

Kaunas, Lithuania

RECRUITING

Santaros KTC (klinikiniu tyrimu centras)

Vilnius, Lithuania

RECRUITING

UAB Alerginių susirgimų diagnostikos ir gydymo centras

Vilnius, Lithuania

RECRUITING

Synexus Polska Sp. z o.o. Oddział w Gdańsku

Gdansk, 80-382, Poland

RECRUITING

Centrum Badań Klinicznych PI-House Sp. z o.o.

Gdansk, 80-546, Poland

RECRUITING

Centrum Medyczne ALL-MED Badania Kliniczne

Krakow, Poland

RECRUITING

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

Krakow, Poland

RECRUITING

Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

Lodz, Poland

NOT YET RECRUITING

Santa Familia PTG Lodz

Lodz, Poland

RECRUITING

Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska

Lublin, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Poland

NOT YET RECRUITING

Medicome Sp. z o.o.

Oświęcim, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie; Klinika Dermatologii i Dermatologii Onkologicznej

Rzeszów, Poland

RECRUITING

Alergo-med Ośrodek Badań Klinicznych Sp. z o. o.

Tarnów, Poland

RECRUITING

MICS Centrum Medyczne Toruń

Torun, Poland

RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, Poland

RECRUITING

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

Wroclaw, Poland

RECRUITING

Worthwhile Clinical Trials

Benoni, South Africa

RECRUITING

Allergy & Immunology Unit, University of Cape Town Lung Institute

Cape Town, South Africa

RECRUITING

Dr. PJ Sebastian

Durban, South Africa

RECRUITING

Infinity Dermatology Inc

Durban, South Africa

RECRUITING

Synapta Clinical Research Centre

Durban, South Africa

RECRUITING

Newtown Clinical Research Centre

Johannesburg, South Africa

RECRUITING

Sandton Medical Research Centre

Johannesburg, South Africa

RECRUITING

Global Clinical Trials (Pty) Ltd

Pretoria, South Africa

RECRUITING

Allergy and Asthma Centre

Westville, South Africa

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

RECRUITING

Addenbrooke's Hospital

Cambridge, United Kingdom

NOT YET RECRUITING

Queen Elizabeth University Hospital

Glasgow, United Kingdom

NOT YET RECRUITING

Salford Care Organisation NCA NHS Trust

Manchester, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Chronic Inducible Urticaria; Cold Urticaria; Familial dermographism

Condition Hierarchy (Ancestors)

Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Celldex Therapeutics

CONTACT

844-723-9363; clinicaltrials@celldex.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 5, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

LI (4); DE (14); ZA (9); ES (2); GB (3); US (26); PL (14)