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Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Sponsor: Celldex Therapeutics
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
Conditions
Interventions
barzolvolimab
Subcutaneous Administration
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