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)

Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Cahaba Dermatology & Skin Health Center, LLC
NOT_YET_RECRUITING
Birmingham
Arizona
One of a Kind Clinical Research Center, LLC
NOT_YET_RECRUITING
Scottsdale
California
Kern Research, Inc.
NOT_YET_RECRUITING
Bakersfield
One of a Kind Clinical Research Center
NOT_YET_RECRUITING
Napa
Allergy & Asthma Consultants
NOT_YET_RECRUITING
Redwood City
Amicis Research Center
NOT_YET_RECRUITING
Sherman Oaks
FOMAT- Allergy, Asthma & Immunology Medical Group
NOT_YET_RECRUITING
Ventura
Florida
Direct Helpers Research Center
NOT_YET_RECRUITING
Hialeah
Well Pharma Medical Research Corporation
NOT_YET_RECRUITING
Miami
Deluxe Health Center, LLC
NOT_YET_RECRUITING
Miami Lakes
GCP, Global Clinical Professionals
RECRUITING
St. Petersburg
Advanced Clinical Research Institute
NOT_YET_RECRUITING
Tampa
Georgia
Centricity Research Columbus Dermatology
NOT_YET_RECRUITING
Columbus
Idaho
Treasure Valley Medical Research
NOT_YET_RECRUITING
Boise
Illinois
Endeavor Health Clinical Trials Center
NOT_YET_RECRUITING
Skokie
Kentucky
Equity Medical, LLC
NOT_YET_RECRUITING
Bowling Green
Advanced ENT & Allergy, PLLC
NOT_YET_RECRUITING
Louisville
Maryland
Johns Hopkins University
NOT_YET_RECRUITING
Baltimore
Michigan
Revival Research Institute, LLC
NOT_YET_RECRUITING
Troy
New York
Equity Medical, LLC
NOT_YET_RECRUITING
New York
Markowitz Medical PLLC dba OptiSkin Medical
NOT_YET_RECRUITING
New York
Ohio
University of Cincinnati
NOT_YET_RECRUITING
Cincinnati
Oklahoma
Allergy, Asthma & Clinical Research Center
RECRUITING
Oklahoma City
South Carolina
Advanced Dermatology and Cosmetic Surgery - Spartanburg
NOT_YET_RECRUITING
Spartanburg
Texas
Rainey & Finklea San Antonio (RFSA) Dermatology
NOT_YET_RECRUITING
San Antonio
Utah
Allergy Associates of Utah
NOT_YET_RECRUITING
Sandy City
Other Locations
Germany
Universitätsklinikum Augsburg - III. Med. Klinik
NOT_YET_RECRUITING
Augsburg
Institut für Allergieforschung (IFA) Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Elbekliniken Buxtehude
NOT_YET_RECRUITING
Buxtehude
Rosenpark Research
NOT_YET_RECRUITING
Darmstadt
University Hospital Dresden
NOT_YET_RECRUITING
Dresden
University Hospital Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
Universitatsklinkum Erlangen-Ulmenweg 18
NOT_YET_RECRUITING
Erlangen
Universitätsklinikum Göttingen
NOT_YET_RECRUITING
Göttingen
Universitätsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
MVZ DermaKiel GmbH
NOT_YET_RECRUITING
Kiel
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
NOT_YET_RECRUITING
Lübeck
LMU Klinikum der Universität
NOT_YET_RECRUITING
München
Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie
NOT_YET_RECRUITING
Münster
Universitäts-Hautklinik Tübingen
NOT_YET_RECRUITING
Tübingen
Lithuania
CD8 Klinika
NOT_YET_RECRUITING
Kaunas
UAB Ausros Medicinos Centras
NOT_YET_RECRUITING
Kaunas
Republic Klaipeda Hospital
NOT_YET_RECRUITING
Klaipėda
Center of Allergy Diagnosis and Treatment
NOT_YET_RECRUITING
Vilnius
Santaros KTC (klinikiniu tyrimu centras)
NOT_YET_RECRUITING
Vilnius
Poland
Centrum Medyczne ALL-MED Badania Kliniczne
NOT_YET_RECRUITING
Krakow
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
NOT_YET_RECRUITING
Krakow
Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
NOT_YET_RECRUITING
Lodz
Santa Familia PTG Lodz
NOT_YET_RECRUITING
Lodz
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska
NOT_YET_RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny w Opolu
NOT_YET_RECRUITING
Opole
Medicome Sp. z o.o.
NOT_YET_RECRUITING
Oświęcim
EMC Instytut Medyczny S.A.PL CERTUS Szpital i Ambulatorium
NOT_YET_RECRUITING
Poznan
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
NOT_YET_RECRUITING
Rzeszów
Alergo-med Ośrodek Badań Klinicznych Spólka z ograniczoną odpowiedzialnością
NOT_YET_RECRUITING
Tarnów
MICS Centrum Medyczne Toruń
NOT_YET_RECRUITING
Torun
Klinika Ambroziak Dermatologia
NOT_YET_RECRUITING
Warsaw
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Sp. Partnerska
NOT_YET_RECRUITING
Wroclaw
Slaski Park Technologii Medycznych Kardio-Med Sile
NOT_YET_RECRUITING
Zabrze
South Africa
Worthwhile Clinical Trials
NOT_YET_RECRUITING
Benoni
Allergy and Immunology Unit, University of Cape Town Lung Institute (UCTLI)
NOT_YET_RECRUITING
Cape Town
Dr. PJ Sebastian
NOT_YET_RECRUITING
Durban
Infinity Dermatology Inc
NOT_YET_RECRUITING
Durban
Synapta Clinical Research Centre
NOT_YET_RECRUITING
Durban
Newtown Clinical Research Centre
NOT_YET_RECRUITING
Johannesburg
Sandton Medical Research Centre
NOT_YET_RECRUITING
Johannesburg
Global Clinical Trials (Pty) Ltd
NOT_YET_RECRUITING
Pretoria
Allergy and Asthma Centre
NOT_YET_RECRUITING
Westville
Spain
Hospital del Mar
NOT_YET_RECRUITING
Barcelona
Clinica Universidad Navarra - Pamplona
NOT_YET_RECRUITING
Pamplona
United Kingdom
Addenbrooke's Hospital
NOT_YET_RECRUITING
Cambridge
Queen Elizabeth University Hospital
NOT_YET_RECRUITING
Glasgow
Salford Care Organisation NCA NHS Trust
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
Celldex Therapeutics
clinicaltrials@celldex.com
844-723-9363
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2028-10
Participants
Target number of participants: 240
Treatments
Experimental: 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
Placebo_comparator: Placebo comparator in patients with Cold Induced Urticaria
Placebo injection subcutaneously every 4 weeks for 24 weeks
Experimental: 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
Placebo_comparator: Placebo comparator in patients with Symptomatic Dermographism
Placebo injection subcutaneously every 4 weeks for 24 weeks
Related Therapeutic Areas
Sponsors
Leads: Celldex Therapeutics

This content was sourced from clinicaltrials.gov