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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
Hospital Base San Jose de Osorno
Osorno, Chile
Enroll SpA - Dr. Manuel Barros Borgono
Providencia, Chile
Clinica Davila - Recoleta
Recoleta, Chile
Centro Internacional de Estudios Clinicos (CIEC)
Recoleta, Chile
BIOCINETIC Ltda
Santiago, Chile
Medical Skin Center
Viña del Mar, Chile
Dermacross Clinica Dermatologica
Vitacura, Chile
Centro Integral de Reumatologia Del Caribe
Barranquilla, Colombia
Hospital Alma Mater de Antioquia
Medellín, Colombia
Centro de Inmunología y Genética - CIGE S.A.S
Medellín, Colombia
Hospital General de Medellín Luz Castro de Gutiérrez
Medellín, Colombia
Fundación Centro de Investigation Clínica CIC
Medellín, Colombia
Fundación Hospital Universidad del Norte
Soledad, Colombia
Special Hospital Medico
Rijeka, Croatia
Solmed Clinic
Zagreb, Croatia
LTD" Healthy Future"
Tbilisi, Georgia
LTD "Center of Allergy and Immunology"
Tbilisi, Georgia
David Abuladze Georgian Italian Clinic
Tbilisi, Georgia
LTD "Multiprofile Clinic Consilium Medulla"
Tbilisi, Georgia
Universitätsklinikum der RWTH Aachen Hautklinik
Aachen, Germany
Fachklinik Bad Bentheim
Bad Bentheim, Germany
Emovis GmbH
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Eurofins bioskin Research Center Dermalology
Hamburg, Germany
UKSH Lübeck, Institut für Entzündungsmedizin
Lübeck, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Universitätsklinikum Münster
Münster, Germany
Hautarztpraxis Dariusch Mortazawi
Remscheid, Germany
Universitäts-Hautklinik, Studienzentrum Immundermatologie
Tübingen, Germany
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen, Hungary
Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary
Allergo-Derm Bakos Kft.
Szolnok, Hungary
Nirmal Hospital PVT LTD
Surat, Gujarat, India
Medical College Baroda & SSG Hospital
Vadodara, Gujarat, India
Shree Hospital & Critical Care Centre
Nagpur, Maharashtra, India
Assured Care Plus Hospital
Nashik, Maharashtra, India
Oyster & Pearl Hospitals
Pune, Maharashtra, India
Excelcare Hospital
Jaipur, Rajasthan, India
G.S.V.M. Medical College - Kanpur
Kanpur, Uttar Pradesh, India
Panchshil Hospital - Ahmedabad
Ahmedabad, India
B. J. Medical College and Civil Hospital
Ahmedabad, India
KLES Dr Prabhakar Kore Hospital & Medical Research Centre
Belagavi, India
All India Institute of Medical Sciences
Bhubaneswar, India
Apex Hospitals Pvt Ltd
Jaipur, India
K R Hospital
Mysore, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, India
Sumandeep Vidyapeeth University - Dhiraj Hospital
Vadodara, India
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Asst Fbf Sacco
Milan, Italy
Azienda Ospedale Università di Padova
Padova, Italy
Humanitas Research Hospital
Rozzano, Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Ospedale San Lazzaro PO Molinette
Torino, Italy
CD8 Klinika
Kaunas, Lithuania
UAB Ausros Medicinos Centras
Kaunas, Lithuania
UAB "Alerginių susirgimų diagnostikos ir gydymo centras"
Vilnius, Lithuania
Santaros KTC (klinikiniu tyrimu centras)
Vilnius, Lithuania
Unidad de Investigación Cima S.a
Chihuahua City, Mexico
Meidadvance Clinical
Chihuahua City, Mexico
Cryptex
Cuauhtémoc, Mexico
Centro de Investigación Medico Biologica
Guadalajara, Mexico
CIMET
Guadalajara, Mexico
Panamerican Guadalajara
Guadalajara, Mexico
Centro de Desarrollo Biomédico
Mérida, Mexico
Mérida Investigación Clínica
Mérida, Mexico
Eukarya Pharmasite
Monterrey, Mexico
CECYPE
Morelia, Mexico
Unidad de Medicina Especializada
San Juan del Río, Mexico
FAICIC
Veracruz, Mexico
AmdsterdamUMC locatie AMC
Amsterdam, Netherlands
Bravis Hospital
Roosendaal, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Optimal Clinical Trials - Central
Auckland, New Zealand
Pcrn Chch
Christchurch, New Zealand
Momentum Clinical Research Dunedin
Dunedin, New Zealand
Lakeland Clinical Trials - Waikato
Hamilton, New Zealand
velocity Nova Sp. z o.o.
Nelson, New Zealand
Pacific Clinical Research Network Rotorua
Rotorua, New Zealand
Momentum Clinical Research Tauranga
Tauranga, New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt, New Zealand
Klinika Dermatologii i Dermatologii Onkologicznej
Częstochowa, Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, Poland
Centrum Kliniczno-Badawcze J.Brzezicki,B.Górnikiewicz-Brzezicka, Lekarze Spółka Partnerska
Elblag, Poland
Synexus Polska Sp. z o.o.
Gdansk, Poland
Mazowieckie Centrum Badań Klinicznych SC IWONA CZAJKOWSKA ANNA PODRAZKA-SZCZEAPANIAK
Grodzisk Mazowiecki, Poland
Provita Sp zoo
Katowice, Poland
Centrum Medyczne "All-Med" Badania Kliniczne
Krakow, Poland
Centrum Medyczne Plejady
Krakow, Poland
Malopolskie Centrum Alergologii
Krakow, Poland
Uniwersytet Medyczny w Łodzi - Centrum Wsparcia Badań Klinicznych
Lodz, Poland
Velocity Nova Sp. z o.o.
Lublin, Poland
Pro Life Medica ETG Lublin
Lublin, Poland
DERMEDIC Iwona Zdybska
Lublin, Poland
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
Lublin, Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne
Nowa Sól, Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland
Medicome Sp. Z O.O.
Oświęcim, Poland
Centrum Alergologii Teresa Hofman Sp. z.o.o.
Poznan, Poland
EMC Instytut Medyczny SA, PL Certus Szpital i Ambulatorium
Poznan, Poland
Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
Poznan, Poland
Uniwersytecki Szpital Kliniczny im. Fryderka Chopina w Rzeszowie Klinika Dermatologii i Dermatologii Onkologicznej
Rzeszów, Poland
EMED Centrum Usług Medycznych Ewa Śmiałek
Rzeszów, Poland
ALERGO-MED SPECJALISTYCZNA PRZYCHODNIA LEKARSKA Spolka. z o. o.
Tarnów, Poland
Medicover Integrated Clinical Services Sp. z o.o. Centrum Medyczne Warszawa
Warsaw, Poland
Synexus Polska Sp. z o.o.
Warsaw, Poland
ETG Warszawa
Warsaw, Poland
MAXDERM s.r.o.
Bardejov, Slovakia
Derma therapy spol. s.r.o.
Bratislava, Slovakia
ALERSA, sro
Košice, Slovakia
Fakultna nemocnica Trnava
Trnava, Slovakia
Hospital del Mar
Barcelona, Spain
Hospital Universitari Puerta del Mar
Cadiz, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital 12 De Octubre
Madrid, Spain
Clinica Universidad Navarra- Pamplona
Pamplona, Spain
Hospital Quironsalud Madrid
Pozuelo de Alarcón, Spain
Hospital universitario Virgen Macarena
Seville, Spain
FutureMeds Sevilla
Seville, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Hospital de Manises
Valencia, Spain
Siriraj Hospital
Bangkok Noi, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand
Thammasat University Hospital
Khlong Luang, Thailand
Khon Kaen University
Khon Kaen, Thailand
Hôpital Hédi Chaker
Sfax, Tunisia
La Rabta Hospital
Tunis, Tunisia
Habib Thameur Hospital
Tunis, Tunisia
Southmead Hospital
Bristol, United Kingdom
Cambridge University Hospitals, Addenbrooke's Hospital
Cambridge, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Velocity Clinical Research High Wycombe
High Wycombe, United Kingdom
St James's University Hospital
Leeds, United Kingdom
The Royal London Hospital
London, United Kingdom
Velocity Clinical Research, North London - PPDS
North Finchley, United Kingdom
Virtual Clinical Trials Centre, The Stables
Oxford, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Velocity Clinical Research - Romford
Romford, United Kingdom
Pinderfields Hospital
Wakefield, United Kingdom