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)
Status: Recruiting
Location: See all (226) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Males and females, \>/= 18 years of age.
• Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
• CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
‣ The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
⁃ Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
⁃ UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
• Normal blood counts and liver function tests.
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.
• Participants with and without prior biologic experience are eligible.
Locations
United States
Alabama
Cahaba Dermatology Skin Health Center
RECRUITING
Birmingham
Arizona
Clear Dermatology & Aesthetics Center Scottsdale
RECRUITING
Scottsdale
California
First OC Dermatology - Fountain Valley
RECRUITING
Fountain Valley
310 Clinical Research
RECRUITING
Inglewood
Dermatology Research Associates
RECRUITING
Los Angeles
Focus Clinical Research - Los Angeles
RECRUITING
Los Angeles
Cura Clinical Research
RECRUITING
Oxnard
Allergy and Asthma Consultants
RECRUITING
Redwood City
Acclaim Clinical Research
RECRUITING
San Diego
Therapeutics Clinical Research
RECRUITING
San Diego
West Dermatology Research Center
RECRUITING
San Diego
Integrated Research of Inland, Inc.
RECRUITING
Upland
Colorado
Western States Clinical Research Inc
RECRUITING
Wheat Ridge
Florida
Encore Medical Research Boynton Beach
RECRUITING
Boynton Beach
Florida Academic Centers Research
RECRUITING
Coral Gables
Direct Helpers Research Center
RECRUITING
Hialeah
GSI Clinical Research
RECRUITING
Margate
International Dermatology Research Inc - Miami
RECRUITING
Miami
Miami Dade Medical Research Institute, LLC
RECRUITING
Miami
Sarasota Clinical Research
RECRUITING
Sarasota
GCP Global Clinical Professionals, LLC
RECRUITING
St. Petersburg
Alliance Clinical Research of Tampa
WITHDRAWN
Tampa
Idaho
Paradigm Clinical Research Boise
RECRUITING
Boise
Illinois
Endeavor Health
RECRUITING
Skokie
Indiana
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
RECRUITING
Clarksville
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
RECRUITING
Indianapolis
Kentucky
DS Research of Kentucky, LLC
RECRUITING
Louisville
Allergy and Asthma Specialists PSC
RECRUITING
Owensboro
Louisiana
Clinical Trials Management LLC - Southshore Office
RECRUITING
Metairie
Maryland
Johns Hopkins Asthma and Allergy Center
RECRUITING
Baltimore
DermAssociates, LLC
RECRUITING
Rockville
Institute For Asthma and Allergy
RECRUITING
Wheaton
Michigan
David Fivenson MD Dermatolgy PLLC
RECRUITING
Ann Arbor
Oakland Hills Dermatology
RECRUITING
Auburn Hills
Resp Medicine Research Institute of MI
RECRUITING
Ypsilanti
Missouri
Dermatolgy and Skin Cancer Center
RECRUITING
Lee's Summit
MediSearch, LLC
RECRUITING
Saint Joseph
Montana
Montana Medical Research
RECRUITING
Missoula
New Jersey
Allergy Partners of N.J., P.C.
RECRUITING
Ocean City
Nevada
Excel Clinical Research - Las Vegas
RECRUITING
Las Vegas
New York
Finger Lakes Medical Research, PLLC
TERMINATED
Cortland
Sadick Research Group
RECRUITING
New York
Ohio
Bexley Dermatology Research
RECRUITING
Bexley
Apex Clinical Research
RECRUITING
Canton
Bernstein Clinical Research Center, LLC
RECRUITING
Cincinnati
Wright State Physicians
RECRUITING
Fairborn
Auni Allergy
RECRUITING
Findlay
Apex Clinical Research Center
RECRUITING
Mayfield Heights
Toledo Institute of Clinical Research
RECRUITING
Toledo
Oklahoma
Southern Plains Medical Center - Chickasha
RECRUITING
Oklahoma City
Oregon
Portland Allergy and Asthma
RECRUITING
Clackamas
Oregon Medical Research Center
RECRUITING
Portland
Pennsylvania
Clinical Research Philadelphia, LLC
RECRUITING
Philadelphia
South Carolina
National Allergy and Asthma Research, LLC - CRN - PPDS
TERMINATED
North Charleston
Texas
Alina Clinical Trials
RECRUITING
Dallas
Zenos Clinical Research
RECRUITING
Dallas
Epic Clinical Research
RECRUITING
Lewisville
VAST Clinical Research - Plano
TERMINATED
Plano
Allergy and Asthma Care of Waco
RECRUITING
Waco
Utah
University of Utah - MidValley Dermatology - PPDS
RECRUITING
Murray
Washington
Premier Clinical Research
RECRUITING
Spokane
Other Locations
Argentina
Buenos Aires Skin
RECRUITING
Buenos Aires
Centro Médico Vitae
RECRUITING
Buenos Aires
Fundacion Cidea
RECRUITING
Buenos Aires
Hospital Italiano De Buenos Aires
RECRUITING
Buenos Aires
Instituto de Alergia e Inmunologia del Sur
RECRUITING
Buenos Aires
Aprillus Asistencia e Investigacion
RECRUITING
Caba
CARE- Centro de Alergia y Enfermedades Respiratorias
RECRUITING
Caba
Conexa Investigacion Clinica
RECRUITING
Caba
CEMLO:Centro de Especialidades Medicas Lobos
RECRUITING
Lobos
Centro Respiratorio Infantil
RECRUITING
Rosario
Instituto de Especialidades de Salud Rosario
RECRUITING
Rosario
Instituto Medico de la Fundacion Estudios Clinicos
RECRUITING
Rosario
Servicio de Investigacion de Patologias Alergicas
RECRUITING
Rosario
C.I.C.E 9 de Julio - Sanatorio 9 de Julio S.A.
RECRUITING
San Miguel De Tucumán
Centro de Investigaciones Medicas Tucuman
RECRUITING
San Miguel De Tucumán
Clinica Mayo
RECRUITING
San Miguel De Tucumán
Belgium
CHU de Liège
RECRUITING
Brussels
Hôpital Erasme - Erasme Medical Center - PPDS
RECRUITING
Brussels
Saint Luc
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
UZ Antwerp
RECRUITING
Edegem
UZ Gent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Dermatologie Maldegem
RECRUITING
Maldegem
Brazil
AlergoAlpha Allergia e Immunologia
RECRUITING
Barueri
Instituto de Pesquisas Clínicas LTDA Brasilia
RECRUITING
Brasília
Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
RECRUITING
Caxias Do Sul
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
RECRUITING
Porto Alegre
Clinica IBIS
RECRUITING
Salvador
Centro de Estudos de Pneumologia da Faculdade de Medecina do ABC
RECRUITING
Santo André
Centro de Pesquisa SVRI Hospital e Maternidade Christóvão da Gama
RECRUITING
Santo André
Clínica de Alergia Martti Antila
RECRUITING
São Paulo
Vidamed Care Clínica E Residência
RECRUITING
Vitória
Bulgaria
Medical center MedTech Services OOD
RECRUITING
Haskovo
Diagnostic Consultative Center Pulmed
RECRUITING
Plovdiv
Aipsimpa D-R Talyat Sali Cholak Eood
RECRUITING
Razgrad
DCC Fokus - 5 OOD LZIBP
RECRUITING
Sofia
MC Excelsior OOD
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Medical Center Iskar EOOD
RECRUITING
Sofia
Medical Center Pulmovision
RECRUITING
Sofia
UMHATEM N.I.Pirogov
RECRUITING
Sofia
Medical Center Zara-Med EOOD
RECRUITING
Stara Zagora
MBAL Sv. Panteleymon AD
RECRUITING
Yambol
Canada
Rejuvenation Dermatology and Aesthetics
RECRUITING
Calgary
Alberta DermaSurgery Centre - Probity - PPDS
RECRUITING
Edmonton
Triple A Lab
RECRUITING
Hamilton
Lynderm Research Inc
RECRUITING
Markham
Centre for Dermatology and Cosmetic Surgery
RECRUITING
Richmond Hill
Skincare Research
RECRUITING
St. John's
Canadian Dermatology Centre - Probity - PPDS
RECRUITING
Toronto
Evidence Based Medical Educator Inc.
RECRUITING
Toronto
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus N
Bispebjerg Hospital
RECRUITING
Copenhagen Nv
Gentofte Hospital
RECRUITING
Hellerup
France
CHU de Grenoble Alpes - Hôpital Michallon
RECRUITING
La Tronche
Cabinet du Dr Ruer-Mulard Mireille
RECRUITING
Martigues
CHRU Nantes Hôtel Dieu
RECRUITING
Nantes
CHU de Nice-Hôpital L'Archet
RECRUITING
Nice
Hôpital La Pitié Salpêtrière
RECRUITING
Paris
Hospices Civils de Lyon - Hôpital Lyon Sud
RECRUITING
Pierre-bénite
CHRU Rouen - Hôpital Charles-Nicolle
RECRUITING
Rouen
Germany
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP - Berlin
RECRUITING
Berlin
MVZ Dermatologisches Zentrum Bonn GmbH - Praxis Friedensplatz
RECRUITING
Bonn
Studienzentrum an der Hase Weyergraf / Frick / Heiber GbR
RECRUITING
Bramsche
Rosenpark Research GmbH
RECRUITING
Darmstadt
ProDerma
RECRUITING
Dülmen
Medizinisches Versorgungszentrum DermaKiel GmbH
RECRUITING
Kiel
UKSH Kiel
RECRUITING
Kiel
Praxis Dr. Beate Schwarz
RECRUITING
Langenau
Siteworks Prüfzentrum Lohne - PPDS
RECRUITING
Löhne
Dermatologie Quist
RECRUITING
Mainz
LMU Klinikum der Universität München
RECRUITING
München
Greece
Andreas Syggros Hospital
RECRUITING
Athens
Naval Hospital of Athens
RECRUITING
Athens
Attikon General University Hospital
RECRUITING
Attiki
General Hospital of Thessaloniki 'Papageorgiou'
RECRUITING
Thessaloniki
Italy
Azienda Ospedaliero Universitaria delle Marche
RECRUITING
Ancona
ASST Carlo Poma
RECRUITING
Mantova
Istituti Clinici Scientifici Maugeri IRCCS
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
Azienda Ospedaliera Ordine Mauriziano di Torino
RECRUITING
Torino
Centro Ricerche Cliniche Verona s.r.l./Ospedale G.B. Rossi Borgo Roma
RECRUITING
Verona
Malaysia
Hospital Pulau Pinang
RECRUITING
George Town
Hospital Raja Permaisuri Bainun
RECRUITING
Ipoh
Hospital Sultan Ismail
RECRUITING
Johor Bahru
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
Hospital Umum Sarawak
RECRUITING
Kuching
Poland
NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL
RECRUITING
Bialystok
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
RECRUITING
Bialystok
Pratia Bydgoszcz
RECRUITING
Bydgoszcz
Ambulatorium Sp. zo.o.
RECRUITING
Elblag
Centrum Badan Klinicznych PI-House Sp. z o.o
RECRUITING
Gdansk
Centrum Medyczne Katowice - PRATIA - PPDS
RECRUITING
Katowice
SYNEXUS POLSKA sp. z o.o. Odział w Katowicach
RECRUITING
Katowice
Polimedica PTG Kielce
RECRUITING
Kielce
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. o.o.
RECRUITING
Krakow
Santa Familia PTG Łódź
RECRUITING
Lodz
Pratia S.A. Centrum Medyczne Pratia Poznań
RECRUITING
Poznan
Specjalistyczna Przychodnai Lekarska Alergo-Med Sp. z o.o.
RECRUITING
Poznan
Synexus Polska Sp. z o.o. - Poznaniu
RECRUITING
Poznan
NSZOZ Puls-Med Anna Bogusz, Agnieszka Musielak spolka jawna
RECRUITING
Skarżysko-kamienna
Laser Clinic S.C
RECRUITING
Szczecin
MICS Centrum Medyczne Torun
RECRUITING
Torun
FutureMeds - Targowek - PPDS
RECRUITING
Warsaw
Klinika Ambroziak Dermatologia
RECRUITING
Warsaw
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
Diagnostic Consultative Center Pulmed
RECRUITING
Wroclaw
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
RECRUITING
Wroclaw
Ginemedica
RECRUITING
Wroclaw
Przychodnia FutureMeds Wroclaw
RECRUITING
Wroclaw
Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o.
RECRUITING
Zabrze
Portugal
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
RECRUITING
Aveiro
Centro Clínico Académico, Braga - Hospital de Braga
RECRUITING
Braga
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
RECRUITING
Coimbra
Hospital Lusiadas Lisboa
RECRUITING
Lisbon
Unidade Local de Saúde de Santa Maria
RECRUITING
Lisbon
ULS de Matosinhos, EPE - Hospital Pedro Hispano
RECRUITING
Matosinhos Municipality
ULS de Santo António, EPE - Hospital de Santo António
RECRUITING
Porto
ULS da Arrábida, EPE - Hospital de São Bernardo
RECRUITING
Setúbal
Unidade Local de Saúde de Gaia/Espinho - Unidade I
RECRUITING
Vila Nova De Gaia
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan
Hanyang University Seoul Hospital
RECRUITING
Seongdong
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
South Africa
Worthwhile Clinical Trials
RECRUITING
Benoni
Iatros International
RECRUITING
Bloemfontein
Synapta Clinical Research
RECRUITING
Durban
Ubuntu Clinical Research
RECRUITING
Krugersdorp
University of Cape Town Lung Institute
RECRUITING
Mowbray
Newtown Clinical Research Centre
RECRUITING
Newtown
Meditrial
RECRUITING
Pietermaritzburg
About Allergy
RECRUITING
Pretoria
Global Clinical Trials
RECRUITING
Pretoria
Ryexo Clinical Research
TERMINATED
Pretoria
Sandton Medical Research Centre
RECRUITING
Sandton
FCRN Clinical Trial Centre
RECRUITING
Vereeniging
Allergy and Asthma Centre
RECRUITING
Westville
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
C.H. Regional Reina Sofia
RECRUITING
Córdoba
Future Meds Madrid
RECRUITING
Madrid
Hospital Clínico San Carlos
RECRUITING
Madrid
Corporació Sanitaria Parc Taulí
RECRUITING
Sabadell
Complejo Asistencial Universitario De Salamanca
RECRUITING
Salamanca
Hospital Universitario de la Plana
RECRUITING
Villarreal De Huerva
Taiwan
National Taiwan University Hospital Hsin-Chu Branch
RECRUITING
Hsinchu
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
Taipei Medical University-Shuang Ho Hospital
RECRUITING
New Taipei City
China Medical University Hospital -PPDS
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
MacKay Memorial Hospital -Taipei branch
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkou
RECRUITING
Taoyuan District
Turkey
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi
RECRUITING
Ankara
Kocaeli Universitesi Tip Fakultesi Hastanesi
RECRUITING
Kocaeli
Ondokuz Mayis University Hospital
RECRUITING
Samsun
Karadeniz Teknik Universitesi Tip Fakultesi Hastanesi
RECRUITING
Trabzon
Contact Information
Primary
Celldex Therapeutics
clinicaltrials@celldex.com
844-723-9363
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2027-04
Participants
Target number of participants: 915
Treatments
Experimental: barzolvolimab 150 mg
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Experimental: barzolvolimab 300 mg
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Experimental: Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
Experimental: Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
Related Therapeutic Areas
Sponsors
Leads: Celldex Therapeutics