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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Sponsor: Celldex Therapeutics
Summary
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
976
Start Date
2024-07-19
Completion Date
2027-04
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
barzolvolimab
Subcutaneous Administration
Matching placebo
Matching placebo Subcutaneous Administration
Locations (245)
Allervie Clinical Research - Cullman
Cullman, Alabama, United States
Research Solutions of Arizona PC
Litchfield Park, Arizona, United States
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
Scottsdale, Arizona, United States
Center for Dermatology & Plastic Surgery
Scottsdale, Arizona, United States
Kern Research, Inc.
Bakersfield, California, United States
UCLA Clinical Trials Contracts & Strategic Relations
Los Angeles, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
LA Universal Research Center, Inc.
Los Angeles, California, United States
Allergy and Asthma Associates of Southern Cal
Mission Viejo, California, United States
Huntington Asthma & Allergy Center
Pasadena, California, United States
Apex Clinical Research
San Diego, California, United States
WR-MCCR
San Diego, California, United States
University Clinical Trials
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Raffi Tachdjian MD, Inc
Santa Monica, California, United States
Clarity Dermatology, PLLC
Castle Rock, Colorado, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, United States
Driven Research LLC
Coral Gables, Florida, United States
Palm Beach Dermatology Group
Delray Beach, Florida, United States
Dolphin Medical Research
Doral, Florida, United States
South FL Clinical Research LLC
Miami, Florida, United States
Dade Florida Clinical Research Center
Miami, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Revival Clinical Research
Orlando, Florida, United States
International Clinical Research - FL LLC
Sanford, Florida, United States
D&H Tamarac Research Center, LLC
Tamarac, Florida, United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, United States
Deluxe Health Center
Tampa, Florida, United States
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Lane Dermatology Research - Centricity - PPDS
Columbus, Georgia, United States
Skin Care Physicians of Georgia
Macon, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Sneeze Wheeze and Itch Associates LLC
Normal, Illinois, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Equity Medical
Bowling Green, Kentucky, United States
Allergy & Asthma Associates
Lexington, Kentucky, United States
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
Baton Rouge, Louisiana, United States
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
Towson, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Derm Institute of Western Michigan
Caledonia, Michigan, United States
Clarkston Skin Research - Clarkston
Clarkston, Michigan, United States
Midwest Clinical Research, LLC
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Skin Specialists PC
Omaha, Nebraska, United States
Hudson-Essex Allergy
Belleville, New Jersey, United States
Impact Medical / Circuit Clinical
Paramus, New Jersey, United States
Impact Medical / Circuit Clinical
Riverdale, New Jersey, United States
Equity Medical LLC
New York, New York, United States
OptiSkin Medical
New York, New York, United States
Optima Research
Boardman, Ohio, United States
Optimed Research Ltd - ClinEdge - PPDS
Columbus, Ohio, United States
Penn State Health Milton Hershey Med Cen
Hershey, Pennsylvania, United States
Clinical Partners LLC
Johnston, Rhode Island, United States
Western Sky Medical Research
El Paso, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Rainey & Finklea San Antonio Dermatology
San Antonio, Texas, United States
Allergy Associates of Utah - Sandy
Murray, Utah, United States
Kalo Clinical Research
West Valley City, Utah, United States
Novatrials
Charlestown, New South Wales, Australia
Skin and Cancer Foundation - The Skin Hospital
Darlinghurst, New South Wales, Australia
St George Dermatology and Skin Cancer Center
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Cornerstone Dermatology
Coorparoo, Queensland, Australia
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Dr Rodney Sinclair Pty Ltd
East Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Medical Centre Asklepii OOD
Dupnitsa, Bulgaria
Medical Center - Pulmo 2018
Haskovo, Bulgaria
Medical Center Medconsult Pleven
Lovech, Bulgaria
Multiprofile Hospital for Active Treatment - Pazardzhik AD
Pazardzhik, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, Bulgaria
Medical Center Prolet
Rousse, Bulgaria
Medical Center Unimed EOOD
Sevlievo, Bulgaria
Diagnostic-consultative center Ascendent EOOD
Sofia, Bulgaria
Diagnostic and Consultative Center Aleksandrovska EOOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"
Sofia, Bulgaria
Diagnostic-Consultative Centre Convex EOOD
Sofia, Bulgaria
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, Canada
Vida Clinical Research
Edmonton, Alberta, Canada
Rejuvenation Dermatology Edmonton South
Edmonton, Alberta, Canada
LEADER research
Hamilton, Ontario, Canada
DermEffects
London, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
York Dermatology Clinic & Research Centre
Richmond Hill, Ontario, Canada
North York Research Inc.
Toronto, Ontario, Canada
Joel Liem Medicine Professional Corporation
Windsor, Ontario, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, Canada
Kingston Health Science Center
Kingston, Canada
Centre de Recherche Saint-Louis (Québec)
Québec, Canada
Clinica MEDS La Dehesa
Lo Barnechea, Chile