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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
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
barzolvolimab
Subcutaneous Administration
Standard of Care
Observational/Standard of Care
Locations (131)
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
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
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
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
Conexa Investigación Clínica S.A.
CABA, Buenos Aires F.D., Argentina
Aprillus Asistencia e Investigacion de Arcis Salud SRL
CABA, Buenos Aires F.D., Argentina
Centro Respiratorio Infantil
Rosario, Sante Fe, Argentina
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
Rosario, Sante Fe, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Sante Fe, Argentina
Clinica Mayo de Urgencias
San Miguel de Tucumán, Tucumán Province, Argentina
Cornerstone Dermatology
Coorparoo, QSL, Australia
The Alfred Hospital - Kern
Melbourne, Victoria, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Medical Centre Asklepii OOD
Dupnitsa, 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
The Diagnostic-Consultative Centre Ascendent EOOD
Sofia, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Bulgaria
Diagnostic Consultative Centre - Focus-5 - LZIP EOOD
Sofia, Bulgaria
Medical Center Hera EOOD
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, Bulgaria
Medical Center Pulmovision
Sofia, Bulgaria
VIDA Dermatology
Edmonton, Alberta, Canada
Lima's Excellence In Allergy And Dermatology Research (Leader) Inc.
Hamilton, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
North Bay Dermatology Center
North Bay, 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 - Dr. Manuel Barros Borgono
Providencia, Chile
Centro Internacional de Estudios Clinicos (CIEC)
Recoleta, Chile
Centro de Estudios Clínicos e Investigaciones Médicas CeCim
Santiago, Chile
Dermacross Clinica Dermatologica
Vitacura, Chile
Gentofte Hospital
Hellerup, Denmark
CHRU Nantes Hôtel Dieu
Nantes, France
CHU de Nice-Hôpital L'Archet
Nice, France
Rosenpark Research
Darmstadt, Hesse, Germany
ProDerma
Dülmen, North Rhine-Westphalia, Germany
Medizinisches Versorgungszentrum DermaKiel GmbH
Kiel, Schleswig-Holstein, Germany
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári, Attica, Greece
Hospital A. Syggros
Athens, Greece
Shree Hospital & Critical Care Centre
Nagpur, Maharashtra, India
G.S.V.M. Medical College
Nashik, Maharashtra, India
Oyster & Pearl Hospitals
Pune, Maharashtra, India
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Italy
CD8 Klinika
Kaunas, Lithuania
Hospital Raja Permaisuri Bainun
Ipoh, Malaysia
Hospital Sultan Ismail
Johor Bahru, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"
Bialystok, Poland
Centrum Medyczne Pratia Częstochowa
Częstochowa, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, Poland
Centrum Medyczne Katowice - PRATIA
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 Dorota Krasowska
Lublin, Poland
Medicome Sp. z o.o.
Oświęcim, Poland
Centrum Medyczne Pratia Poznan
Poznan, Poland
Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.
Skarżysko-Kamienna, Poland
Alergo-med Ośrodek Badań Klinicznych Spólka z ograniczoną odpowiedzialnością
Tarnów, Poland
MICS Centrum Medyczne Toruń
Torun, Poland
ETG Warszawa Sp. z o.o.
Warsaw, Poland
Klinika Ambroziak Dermatologia
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
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro, Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria
Lisbon, Portugal
ULS da Arrábida, EPE - Hospital de São Bernardo
Setúbal, Portugal
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
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 Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Clinico San Carlos - Lopez Bran
Madrid, 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
National Taiwan University Hospital
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
Thammasat University Hospital
Khlong Luang, Thailand
Velocity Clinical Research, North London
North Finchley, United Kingdom