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ACTIVE NOT RECRUITING
NCT06455202
PHASE3

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

Sponsor: Celldex Therapeutics

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

barzolvolimab

Subcutaneous Administration

BIOLOGICAL

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