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ENROLLING BY INVITATION
NCT07256392
PHASE3

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Sponsor: Celldex Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Official title: A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1370

Start Date

2025-11-25

Completion Date

2028-09

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

barzolvolimab

Subcutaneous Administration

OTHER

Standard of Care

Observational/Standard of Care

Locations (182)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, United States

Medical Research of Arizona

Scottsdale, Arizona, United States

Center for Dermatology & Plastic Surgery - Avacare

Scottsdale, Arizona, United States

Kern Research

Bakersfield, California, United States

Allergy and Asthma Associates of Southern California - Laguna Niguel - CRN

Laguna Niguel, California, United States

California Allergy and Asthma Medical Group

Los Angeles, California, United States

Dermatology Research Associates

Los Angeles, California, United States

LA Universal Research Center, Inc.

Los Angeles, California, United States

Asthma and Allergy Associates

Colorado Springs, Colorado, United States

Encore Medical Research of Boynton Beach LLC

Boynton Beach, Florida, United States

Dolphin Medical Research

Doral, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States

Deluxe Health Center

Miami Lakes, Florida, United States

Sarasota Clinical Research

Sarasota, Florida, United States

GCP, Global Clinical Professionals

St. Petersburg, Florida, United States

Advanced Clinical Research Institute (ACRI) - Florida

Tampa, Florida, United States

Centricity Research Columbus Dermatology

Columbus, Georgia, United States

Endeavor Health

Skokie, Illinois, United States

The South Bend Clinic - Avacare

South Bend, Indiana, United States

Allergy and Asthma Specialists PSC

Owensboro, Kentucky, United States

John Hopkins University

Baltimore, Maryland, United States

DermAssociates, LLC

Rockville, Maryland, United States

Institute for Asthma and Allergy

Wheaton, Maryland, United States

Michigan Center for Research Co., LLC

Clarkston, Michigan, United States

Respiratory Medicine Research Institute of Michigan PLC

Ypsilanti, Michigan, United States

Midwest Clinical Research

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Montana Medical Research, Inc.

Missoula, Montana, United States

Allergy Partners of NJ, PC

Ocean City, New Jersey, United States

Markowitz Medical PLLC dba OptiSkin Medical

New York, New York, United States

Bexley Dermatology Research

Bexley, Ohio, United States

Auni Allergy

Findlay, Ohio, United States

Toledo Institute for Clinical Research

Toledo, Ohio, United States

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Portland Allergy and Asthma

Clackamas, Oregon, United States

Clinical Partners LLC

Johnston, Rhode Island, United States

Alina Clinical Trials LLC

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Rainey & Finklea San Antonio (RFSA) Dermatology

San Antonio, Texas, United States

Allergy and Asthma Care of Waco

Waco, Texas, United States

Allergy Associates of Utah

Sandy City, Utah, United States

Kalo Clinical Research

West Valley City, Utah, United States

Fundación CIDEA

Buenos Aires, Buenos Aires, Argentina

CEMLO - Centro de Especialidades Médicas Lobos

Lobos, Buenos Aires, Argentina

Conexa Investigación Clínica S.A.

CABA, Buenos Aires F.D., Argentina

Aprillus Asistencia e Investigacion

CABA, Buenos Aires F.D., Argentina

Centro de Investigaciones Clinicas - Instituto Especialidades de la Salud Rosario

Rosario, Sante Fe, Argentina

Centro Respiratorio Infantil

Rosario, Sante Fe, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Sante Fe, Argentina

Clinica Mayo de U.M.C.B.

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, Tucumán Province, Argentina

Cornerstone Dermatology

Coorparoo, QSL, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Cliniques Universitaires Saint-Luc - PPDS

Brussels, Belgium

Medical Centre Asklepii OOD

Dupnitsa, Bulgaria

Medical Center Pulmo - 2018 EOOD

Haskovo, Bulgaria

Medical Center Medtech Services EOOD

Haskovo, Bulgaria

Outpatient Clinic for IP for Specialized Outpatient Medical Care in Allergology-Dr.Cholak

Razgrad, Bulgaria

Medical Center Iskar EOOD

Sofia, Bulgaria

Diagnostic and Consultative Center Ascendent EOOD

Sofia, Bulgaria

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

Sofia, Bulgaria

Diagnostic and Consultative Center Focus-5 - Medical Establishment for Outpatient care OOD

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine "N. I. Pirogov" EAD, Multiprofile Emergency Department, Allergology room

Sofia, Bulgaria

Diagnostic-Consultative Center Convex EOOD

Sofia, Bulgaria

Medical Center Pulmovision

Sofia, Bulgaria

MBAL Sv. Panteleymon AD - Yambol

Yambol, Bulgaria

Alberta DermaSurgery Centre

Edmonton, Alberta, Canada

Vida Clinical Research

Edmonton, Alberta, Canada

LEADER research

Hamilton, Ontario, Canada

Triple A Lab, Inc.

Hamilton, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

North Bay Dermatology Centre

North Bay, Ontario, Canada

North York Research Inc.

Toronto, Ontario, Canada

Evidence Based Medical Educator Inc.

Toronto, Ontario, Canada

Joel Liem Medicine Professional Corporation

Windsor, Ontario, Canada

Centre de Recherche Saint-Louis

Québec, Canada

Enroll SpA

Providencia, Chile

Centro Internacional de Estudios Clinicos (CIEC)

Recoleta, Chile

Biocinetic Servicios Medicos Ltda

Santiago, Chile

Clínica Dermacross S.A.

Vitacura, Chile

Centro de Inmunologia y Genetica CIGE S.A.S.

Medellín, Colombia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Aarhus Universitetshospital

Aarhus N, Denmark

Gentofte Hospital, Department of Dermatology and Allergy

Hellerup, Denmark

CHRU Nantes Hôtel Dieu

Nantes, France

CHU de Nice-Hôpital L'Archet

Nice, France

CHU de Nice. Hôpital L'Archet 2

Nice, France

Healthy Future

Tbilisi, Georgia

Center of Allergy and Immunology - Gotua

Tbilisi, Georgia

Rosenpark Research GmbH

Darmstadt, Hesse, Germany

ProDerma, Dr. Rolf Dominicus

Dülmen, North Rhine-Westphalia, Germany

MVZ DermaKiel GmbH

Kiel, Schleswig-Holstein, Germany

Fachklinik Bad Bentheim, Dept. of Dermatology, Klinisches Studienzentrum

Bad Bentheim, Germany

Dermatologie Quist

Mainz, Germany

Universitäts-Hautklinik Tübingen, Studienzentrum Immundermatologie

Tübingen, Germany

"University General Hospital ""ATTIKON""- General Hospital of West Attica ""H AGIA VARVARA"", Allergy Unit, Allergy Unit ""Dimitrios Kalogeromitros"", 2nd Department of Dermatology & Venereology NKUA"

Chaïdári, Attica, Greece

Hospital of Venereal and Dermatological Diseases Andreas Syggros, 1st Department of Dermatology and Venereology NKUA

Athens, Greece

Allergo-Derm Bakos Kft.

Szolnok, Hungary

Nirmal Hospital - Surat

Surat, Gujarat, India

Badoda Medical College and SSG Hospital - Vadodara

Vadodara, Gujarat, India

Sumandeep Vidyapeeth University - Dhiraj Hospital

Vadodara, Gujarat, India

Shree Hospital & Critical Care Centre

Nagpur, Maharashtra, India

Assured Care Plus Hospital

Nashik, Maharashtra, India

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashtra, India

Oyster& Pearl Hospitals (Phadnis Clinic Pvt Ltd)

Pune, Maharashtra, India

Assured Care Plus Hospital

Kanpur, Uttar Pradesh, India

ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

Milan, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, Italy

CD8 Klinika UAB

Kaunas, Lithuania

Hospital Pulau Pinang

George Town, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Malaysia

Hospital Sultan Ismail

Johor Bahru, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

University Medical Center Utrecht

Utrecht, Netherlands

NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL" S.C.

Bialystok, Poland

Centrum Medyczne PRATIA Częstochowa

Częstochowa, Poland

Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.

Elblag, Poland

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Poland

Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, Poland

Pratia S.A.

Katowice, Poland

Centrum Medyczne All-Med Badania Kliniczne

Krakow, Poland

Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

Krakow, Poland

LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n med. Dorota Krasowska

Lublin, Poland

Medicome Sp. z o.o.

Oświęcim, Poland

Pratia S.A

Poznan, Poland

Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen

Poznan, Poland

EMed Centrum Uslug Medycznych

Rzeszów, Poland

Niepubliczny Specjalistyczny Zaklad Opieki ZdrowotnejPuls-Med Anna Bogusz Agnieszka Musielak Sp. j.

Skarżysko-Kamienna, Poland

Laser Clinic S.C.

Szczecin, Poland

ALERGO-MED Osrodek Badan Klinicznych Sp. z o. o.

Tarnów, Poland

MICS Centrum Medyczne Toruń

Torun, Poland

Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, Poland

ETG Warszawa Sp. z o.o.

Warsaw, Poland

Klinika Ambroziak Dermatologia

Warsaw, Poland

Royalderm

Warsaw, Poland

Ginemedica Sp. z o.o.

Wroclaw, Poland

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

Wroclaw, Poland

Unidade Local de Saude da Região de Aveiro, E.P.E. - Hospital Infante D. Pedro

Aveiro, Portugal

Unidade Local De Satide De Coimbra E.P.E.

Coimbra, Portugal

Hospital Lusíadas Lisboa

Lisbon, Portugal

Unidade Local de Satide de Santa Maria E.P.E. - Hospital de Santa Maria

Lisbon, Portugal

Hospital de São Bernardo, Unidade Local de Saúde da Arrábida (ULSA)

Setúbal, Portugal

Alersa s.r.o.

Košice, Slovakia

Worthwhile Clinical Trials

Benoni, Gauteng, South Africa

Newtown Clinical Research Centre

Newtown, Gauteng, South Africa

Global Clinical Trials (Pty) Ltd - Pretoria

Pretoria, Gauteng, South Africa

About Allergy

Pretoria, Gauteng, South Africa

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

University of Cape Town Lung Institute (UCTLI)

Mowbray, Western Cape, South Africa

Korea University Ansan Hospital

Ansan, South Korea

Seoul National University Hospital

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital del Mar

Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Universitario Puerta del Mar

Barcelona, Spain

Hospital Clinico San Carlos - Lopez Bran

Madrid, Spain

Corporació Sanitaria Parc Taulí

Sabadell, Spain

Hospital Universitario de La Plana

Villarreal de Huerva, Spain

National Taiwan University Hospital - Hsin-Chu Branch

Hsinchu, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Siriraj Hospital Mahidol University

Bangkok Noi, Thailand

Faculty of Medicine, Thammasat University

Khlong Luang, Thailand

Faculte de Medecine de Sfax - CHU Hedi Chaker

Sfax, Tunisia

St James's University Hospital, The Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Southmead Hospital, North Bristol NHS Trust

Bristol, United Kingdom

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Velocity Clinical Research, North London

North Finchley, United Kingdom