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)
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)
1 other identifier
interventional
240
7 countries
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2026
Typical duration for phase_3
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedStudy Start
First participant enrolled
January 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
March 27, 2026
March 1, 2026
2.4 years
November 19, 2025
March 26, 2026
Conditions
Keywords
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 (16)
Change from baseline in Critical Temperature Threshold (CTT) at Week 12
From Day 1 (first dose) to Week 12
Change from baseline in Critical Friction Threshold (CFT) at Week 12
From Day 1 (first dose) to Week 12
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 participants
From Day 1 (first dose) to Week 24
Change from baseline in Critical Temperature Threshold (CTT) at Week 24
From Day 1 (first dose) to Week 24
- +11 more secondary outcomes
Study Arms (4)
barzolvolimab 450mg loading dose followed by 150mg in patients with Cold Induced Urticaria
EXPERIMENTALbarzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks
Placebo comparator in patients with Cold Induced Urticaria
PLACEBO COMPARATORPlacebo injection subcutaneously every 4 weeks for 24 weeks
barzolvolimab 450mg loading dose followed by 150mg in patients with Symptomatic Dermographism
EXPERIMENTALbarzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks
Placebo comparator in patients with Symptomatic Dermographism
PLACEBO COMPARATORPlacebo injection subcutaneously every 4 weeks for 24 weeks
Interventions
Subcutaneous Administration
Subcutaneous Administration
Eligibility Criteria
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 ≥ 10 °C and \< 37 °C using the TempTest® and a numerical rating scale score of ≥ 3 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 ≥ 3 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 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, 35244, United States
One of a Kind Clinical Research Center, LLC
Scottsdale, Arizona, 85258, United States
Kern Research, Inc.
Bakersfield, California, 93301, United States
One of a Kind Clinical Research Center
Napa, California, 94558, United States
Allergy & Asthma Consultants
Redwood City, California, 94063, United States
Amicis Research Center
Sherman Oaks, California, 91403, United States
FOMAT - Allergy, Asthma & Immunology Medical Group
Ventura, California, 93003, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
Well Pharma Medical Research, Corp.
Miami, Florida, 33143, United States
Deluxe Health Center, LLC
Miami Lakes, Florida, 33014, United States
GCP, Global Clinical Professionals
St. Petersburg, Florida, 33705, United States
Advanced Clinical Research Institute
Tampa, Florida, 33607, United States
Centricity Research Columbus Dermatology
Columbus, Georgia, 31904, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, 60077, United States
Equity Medical, LLC
Bowling Green, Kentucky, 42104, United States
Advanced ENT and Allergy, PLLC
Louisville, Kentucky, 40207, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Revival Research Institute, LLC
Troy, Michigan, 48084, United States
Equity Medical, LLC
New York, New York, 10023, United States
Markowitz Medical PLLC dba OptiSkin Medical
New York, New York, 10128, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120, United States
Advanced Dermatology and Cosmetic Surgery - Spartanburg
Spartanburg, South Carolina, 29307, United States
RFSA Dermatology
San Antonio, Texas, 78212, United States
Allergy Associates of Utah
Sandy City, Utah, 84093, 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
Worthwhile Clinical Trials
Benoni, South Africa
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
March 27, 2026
Record last verified: 2026-03