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ACTIVE NOT RECRUITING
NCT06445023
PHASE3

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

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-CSU1)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

963

Start Date

2024-07-11

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 (235)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, United States

First OC Dermatology - Fountain Valley

Fountain Valley, California, United States

310 Clinical Research

Inglewood, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Focus Clinical Research - Los Angeles

Los Angeles, California, United States

Cura Clinical Research

Oxnard, California, United States

Allergy and Asthma Consultants

Redwood City, California, United States

Acclaim Clinical Research

San Diego, California, United States

West Dermatology Research Center

San Diego, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Orso Health, Inc.

Torrance, California, United States

Integrated Research of Inland, Inc.

Upland, California, United States

Western States Clinical Research Inc

Wheat Ridge, Colorado, United States

Encore Medical Research Boynton Beach

Boynton Beach, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

GSI Clinical Research

Margate, Florida, United States

International Dermatology Research Inc - Miami

Miami, Florida, United States

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Sarasota Clinical Research

Sarasota, Florida, United States

GCP Global Clinical Professionals, LLC

St. Petersburg, Florida, United States

Paradigm Clinical Research Boise

Boise, Idaho, United States

Endeavor Health

Skokie, Illinois, United States

Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave

Indianapolis, Indiana, United States

DS Research of Kentucky, LLC

Louisville, Kentucky, United States

Allergy and Asthma Specialists PSC

Owensboro, Kentucky, United States

Clinical Trials Management LLC - Southshore Office

Metairie, Louisiana, United States

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

DermAssociates, LLC

Rockville, Maryland, United States

Institute For Asthma and Allergy

Wheaton, Maryland, United States

David Fivenson MD Dermatolgy PLLC

Ann Arbor, Michigan, United States

Resp Medicine Research Institute of MI

Ypsilanti, Michigan, United States

Dermatolgy and Skin Cancer Center

Lee's Summit, Missouri, United States

MediSearch, LLC

Saint Joseph, Missouri, United States

Montana Medical Research

Missoula, Montana, United States

Excel Clinical Research - Las Vegas

Las Vegas, Nevada, United States

Allergy Partners of N.J., P.C.

Ocean City, New Jersey, United States

Finger Lakes Medical Research, PLLC

Cortland, New York, United States

Sadick Research Group

New York, New York, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Apex Clinical Research

Canton, Ohio, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Wright State Physicians

Fairborn, Ohio, United States

Auni Allergy

Findlay, Ohio, United States

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma, United States

Portland Allergy and Asthma

Clackamas, Oregon, United States

Oregon Medical Research Center

Portland, Oregon, United States

Clinical Research Philadelphia, LLC

Philadelphia, Pennsylvania, United States

National Allergy and Asthma Research, LLC - CRN - PPDS

North Charleston, South Carolina, United States

Alina Clinical Trials

Dallas, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

VAST Clinical Research - Plano

Plano, Texas, United States

STAAMP Research, LLC - CRN

San Antonio, Texas, United States

Allergy and Asthma Care of Waco

Waco, Texas, United States

University of Utah - MidValley Dermatology - PPDS

Murray, Utah, United States

Premier Clinical Research

Spokane, Washington, United States

Buenos Aires Skin

Buenos Aires, Buenos Aires, Argentina

Fundacion Cidea

Buenos Aires, Buenos Aires, Argentina

CEMLO:Centro de Especialidades Medicas Lobos

Lobos, Buenos Aires, Argentina

Hospital Italiano De Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Conexa Investigacion Clinica

CABA, Buenos Aires F.D., Argentina

Aprillus Asistencia e Investigacion

CABA, Buenos Aires F.D., Argentina

CARE- Centro de Alergia y Enfermedades Respiratorias

CABA, Buenos Aires F.D., Argentina

Centro Respiratorio Infantil

Rosario, Sante Fe, Argentina

Instituto de Especialidades de Salud Rosario

Rosario, Sante Fe, Argentina

Servicio de Investigacion de Patologias Alergicas

Rosario, Sante Fe, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Sante Fe, Argentina

C.I.C.E 9 de Julio - Sanatorio 9 de Julio S.A.

San Miguel de Tucumán, Tucumán Province, Argentina

Clinica Mayo

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Médico Vitae

Buenos Aires, Argentina

Instituto de Alergia e Inmunologia del Sur

Buenos Aires, Argentina

UZ Antwerp

Edegem, Antwerpen, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

UZ Brussel

Brussels, Belgium

Saint Luc

Brussels, Belgium

CHU de Liège

Brussels, Belgium

Hôpital Erasme - Erasme Medical Center - PPDS

Brussels, Belgium

UZ Gent

Ghent, Belgium

Dermatologie Maldegem

Maldegem, Belgium

AlergoAlpha Allergia e Immunologia

Barueri, Brazil

Instituto de Pesquisas Clínicas LTDA Brasilia

Brasília, Brazil

Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde

Caxias do Sul, Brazil

Centro Paraibano de Pesquisas e Estudos Clínicos

João Pessoa, Brazil

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Porto Alegre, Brazil

Hospital Universitário Clementino Fraga Filho (UFRJ)

Rio de Janeiro, Brazil

Clinica IBIS

Salvador, Brazil

Centro de Estudos de Pneumologia da Faculdade de Medecina do ABC

Santo André, Brazil

Centro de Pesquisa SVRI Hospital e Maternidade Christóvão da Gama

Santo André, Brazil

Clínica de Alergia Martti Antila

São Paulo, Brazil

Vidamed Care Clínica E Residência

Vitória, Brazil

"Medical center MedTech Services" OOD

Haskovo, Bulgaria

Diagnostic Consultative Center Pulmed

Plovdiv, Bulgaria

Aipsimpa D-R Talyat Sali Cholak Eood

Razgrad, Bulgaria

Medical Center Iskar EOOD

Sofia, Bulgaria

MC Excelsior OOD

Sofia, Bulgaria

DCC Fokus - 5 OOD LZIBP

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

And 135 more locations on ClinicalTrials.gov