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)
NCT ID: NCT07266402
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2026-01-15
2028-10-31
Brief Summary
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Detailed Description
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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. Then there is 16-week follow-up period where all patients are observed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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barzolvolimab 450mg loading dose followed by 150mg in patients with Cold Induced Urticaria
barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks
Barzolvolimab
Subcutaneous Administration
Placebo comparator in patients with Cold Induced Urticaria
Placebo injection subcutaneously every 4 weeks for 24 weeks
Matching Placebo
Subcutaneous Administration
barzolvolimab 450mg loading dose followed by 150mg in patients with Symptomatic Dermographism
barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks
Barzolvolimab
Subcutaneous Administration
Placebo comparator in patients with Symptomatic Dermographism
Placebo injection subcutaneously every 4 weeks for 24 weeks
Matching Placebo
Subcutaneous Administration
Interventions
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Barzolvolimab
Subcutaneous Administration
Matching Placebo
Subcutaneous Administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 ≥ 10 °C and \< 37 °C using the TempTest® and a numerical rating scale score of ≥ 3 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 ≥ 3 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.
Exclusion Criteria
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 of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination 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.
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States
One of a Kind Clinical Research Center, LLC
Scottsdale, Arizona, United States
Kern Research, Inc.
Bakersfield, California, United States
One of a Kind Clinical Research Center
Napa, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
Amicis Research Center
Sherman Oaks, California, United States
FOMAT - Allergy, Asthma & Immunology Medical Group
Ventura, California, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Well Pharma Medical Research, Corp.
Miami, Florida, United States
Deluxe Health Center, LLC
Miami Lakes, Florida, United States
GCP, Global Clinical Professionals
St. Petersburg, Florida, United States
Advanced Clinical Research Institute
Tampa, Florida, United States
Centricity Research Columbus Dermatology
Columbus, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States
Equity Medical, LLC
Bowling Green, Kentucky, United States
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Equity Medical, LLC
New York, New York, United States
Markowitz Medical PLLC dba OptiSkin Medical
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States
Advanced Dermatology and Cosmetic Surgery - Spartanburg
Spartanburg, South Carolina, United States
RFSA Dermatology
San Antonio, Texas, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Universitätsklinikum Augsburg - III. Med. Klinik
Augsburg, , Germany
Institut für Allergieforschung (IFA) Charité - Universitätsmedizin Berlin
Berlin, , Germany
Elbekliniken Buxtehude
Buxtehude, , Germany
Rosenpark Research
Darmstadt, , Germany
University Hospital Dresden
Dresden, , Germany
University Hospital Düsseldorf
Düsseldorf, , Germany
Universitatsklinkum Erlangen-Ulmenweg 18
Erlangen, , Germany
Universitätsklinikum Göttingen
Göttingen, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
MVZ DermaKiel GmbH
Kiel, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
LMU Klinikum der Universität
München, , Germany
Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie
Münster, , Germany
Universitäts-Hautklinik Tübingen
Tübingen, , Germany
CD8 Klinika
Kaunas, , Lithuania
UAB Ausros Medicinos Centras
Kaunas, , Lithuania
Republic Klaipeda Hospital
Klaipėda, , Lithuania
Center of Allergy Diagnosis and Treatment
Vilnius, , Lithuania
Santaros KTC (klinikiniu tyrimu centras)
Vilnius, , Lithuania
Centrum Medyczne ALL-MED Badania Kliniczne
Krakow, , Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Krakow, , Poland
"Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi"
Lodz, , Poland
Santa Familia PTG Lodz
Lodz, , Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska
Lublin, , Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, , Poland
Medicome Sp. z o.o.
Oświęcim, , Poland
EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
Poznan, , Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, , Poland
Alergo-med Ośrodek Badań Klinicznych Spólka z ograniczoną odpowiedzialnością
Tarnów, , Poland
MICS Centrum Medyczne Toruń
Torun, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Sp. Partnerska
Wroclaw, , Poland
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Allergy and Immunology Unit, University of Cape Town Lung Institute (UCTLI)
Cape Town, , South Africa
Dr. PJ Sebastian
Durban, , South Africa
Infinity Dermatology Inc
Durban, , South Africa
Synapta Clinical Research Centre
Durban, , South Africa
Newtown Clinical Research Centre
Johannesburg, , South Africa
Sandton Medical Research Centre
Johannesburg, , South Africa
Global Clinical Trials (Pty) Ltd
Pretoria, , South Africa
Allergy and Asthma Centre
Westville, , South Africa
Hospital del Mar
Barcelona, , Spain
Clinica Universidad Navarra - Pamplona
Pamplona, , Spain
Addenbrooke's Hospital
Cambridge, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Salford Care Organisation NCA NHS Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CDX0159-16
Identifier Type: -
Identifier Source: org_study_id
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