A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
NCT ID: NCT06445023
Last Updated: 2026-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
915 participants
INTERVENTIONAL
2024-07-11
2027-04-30
Brief Summary
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Detailed Description
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There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.
Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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barzolvolimab 150 mg
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
barzolvolimab
Subcutaneous Administration
barzolvolimab 300 mg
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
barzolvolimab
Subcutaneous Administration
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.
barzolvolimab
Subcutaneous Administration
Matching placebo
Matching placebo Subcutaneous Administration
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.
barzolvolimab
Subcutaneous Administration
Matching placebo
Matching placebo Subcutaneous Administration
Interventions
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barzolvolimab
Subcutaneous Administration
Matching placebo
Matching placebo Subcutaneous Administration
Eligibility Criteria
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Inclusion Criteria
2. Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
7. Participants with and without prior biologic experience are eligible.
Exclusion Criteria
2. Chronic urticaria whose predominant manifestation is due to CIndU.
3. Other diseases associated with urticaria.
4. Active pruritic skin condition in addition to CSU.
5. Medical condition that would cause additional risk or interfere with study procedures.
6. Known HIV, hepatitis B or hepatitis C infection.
7. Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
8. History of anaphylaxis.
9. Prior treatment with barzolvolimab.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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Cahaba Dermatology Skin Health Center
Birmingham, Alabama, United States
Investigate MD, LLC
Scottsdale, Arizona, 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
Florida Academic Centers Research
Coral Gables, 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
Alliance Clinical Research of Tampa
Tampa, Florida, United States
Paradigm Clinical Research Boise
Boise, Idaho, United States
Endeavor Health
Skokie, Illinois, United States
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville, Indiana, 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
Oakland Hills Dermatology
Auburn Hills, 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
Lynn Health Science Institute
Oklahoma City, Oklahoma, 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
UMHATEM " N.I.Pirogov"
Sofia, , Bulgaria
Medical Center Pulmovision
Sofia, , Bulgaria
Medical Center "Zara-Med" EOOD
Stara Zagora, , Bulgaria
MBAL Sv. Panteleymon AD
Yambol, , Bulgaria
Alberta DermaSurgery Centre - Probity - PPDS
Edmonton, Alberta, Canada
Skincare Research
St. John's, Newfoundland and Labrador, Canada
Triple A Lab
Hamilton, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
Centre for Dermatology and Cosmetic Surgery
Richmond Hill, Ontario, Canada
Canadian Dermatology Centre - Probity - PPDS
Toronto, Ontario, Canada
Evidence Based Medical Educator Inc.
Toronto, Ontario, Canada
Rejuvenation Dermatology and Aesthetics
Calgary, , Canada
Fakultní nemocnice Královské Vinohrady, Dermatovenerologická klinika
Prague, , Czechia
Sanatorium profesora Arenbergera
Prague, , Czechia
Kožní ambulance Fialová, s.r.o.
Prague, , Czechia
Fakultní nemocnice Bulovka, Dermatovenerologická klinika
Prague, , Czechia
Aarhus Universitetshospital
Aarhus N, , Denmark
Bispebjerg Hospital
Copenhagen NV, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Hospices Civils de Lyon - Hôpital Lyon Sud
Pierre-Bénite, Rhone, France
CHU de Grenoble Alpes - Hôpital Michallon
La Tronche, , France
Cabinet du Dr Ruer-Mulard Mireille
Martigues, , France
CHRU Nantes Hôtel Dieu
Nantes, , France
CHU de Nice-Hôpital L'Archet
Nice, , France
Hôpital La Pitié Salpêtrière
Paris, , France
CHRU Rouen - Hôpital Charles-Nicolle
Rouen, , France
Praxis Dr. Beate Schwarz
Langenau, Baden-Wurttemberg, Germany
Rosenpark Research GmbH
Darmstadt, Hesse, Germany
Siteworks Prüfzentrum Lohne - PPDS
Löhne, Lower Saxony, Germany
MVZ Dermatologisches Zentrum Bonn GmbH - Praxis Friedensplatz
Bonn, North Rhine-Westphalia, Germany
ProDerma
Dülmen, North Rhine-Westphalia, Germany
UKSH Kiel
Kiel, Schleswig-Holstein, Germany
Medizinisches Versorgungszentrum DermaKiel GmbH
Kiel, Schleswig-Holstein, Germany
Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP - Berlin
Berlin, , Germany
Studienzentrum an der Hase Weyergraf / Frick / Heiber GbR
Bramsche, , Germany
Dermatologie Quist
Mainz, , Germany
LMU Klinikum der Universität München
München, , Germany
Naval Hospital of Athens
Athens, , Greece
Andreas Syggros Hospital
Athens, , Greece
Attikon General University Hospital
Attiki, , Greece
General Hospital of Thessaloniki 'Papageorgiou'
Thessaloniki, , Greece
Azienda Ospedaliero Universitaria delle Marche
Ancona, , Italy
ASST Carlo Poma
Mantova, , Italy
Istituti Clinici Scientifici Maugeri IRCCS
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, , Italy
Centro Ricerche Cliniche Verona s.r.l./Ospedale G.B. Rossi Borgo Roma
Verona, , Italy
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
Clinica Internacional - Sede Lima
Lima, , Peru
Clinica Ricardo Palma
Lima, , Peru
Clinica San Felipe
Lima, , Peru
Medic Ser S.A.C. Auna Clinica Delgado
Lima, , Peru
NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"
Bialystok, , Poland
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
Bialystok, , Poland
Pratia Bydgoszcz
Bydgoszcz, , Poland
Ambulatorium Sp. zo.o.
Elblag, , Poland
Centrum Badan Klinicznych PI-House Sp. z o.o
Gdansk, , Poland
"SYNEXUS POLSKA" sp. z o.o. Odział w Katowicach
Katowice, , Poland
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, , Poland
Polimedica PTG Kielce
Kielce, , Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. o.o.
Krakow, , Poland
Santa Familia PTG Łódź
Lodz, , Poland
Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwesytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi
Lodz, , Poland
Pratia S.A. Centrum Medyczne Pratia Poznań
Poznan, , Poland
Specjalistyczna Przychodnai Lekarska Alergo-Med Sp. z o.o.
Poznan, , Poland
Synexus Polska Sp. z o.o. - Poznaniu
Poznan, , Poland
NSZOZ Puls-Med Anna Bogusz, Agnieszka Musielak spolka jawna
Skarżysko-Kamienna, , Poland
Laser Clinic S.C
Szczecin, , Poland
MICS Centrum Medyczne Torun
Torun, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
FutureMeds - Targowek - PPDS
Warsaw, , Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, , Poland
Ginemedica
Wroclaw, , Poland
Diagnostic Consultative Center Pulmed
Wroclaw, , Poland
Przychodnia FutureMeds Wroclaw
Wroclaw, , Poland
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
Wroclaw, , Poland
Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o.
Zabrze, , Poland
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro, , Portugal
Centro Clínico Académico, Braga - Hospital de Braga
Braga, , Portugal
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Hospital Lusiadas Lisboa
Lisbon, , Portugal
Unidade Local de Saúde de Santa Maria
Lisbon, , Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
ULS de Santo António, EPE - Hospital de Santo António
Porto, , Portugal
ULS da Arrábida, EPE - Hospital de São Bernardo
Setúbal, , Portugal
Unidade Local de Saúde de Gaia/Espinho - Unidade I
Vila Nova de Gaia, , Portugal
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Corporació Sanitaria Parc Taulí
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Hospital Universitari Vall d'Hebron
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C.H. Regional Reina Sofia
Córdoba, , Spain
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Complejo Asistencial Universitario De Salamanca
Salamanca, , Spain
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National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, , Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
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Chang Gung Memorial Hospital, Linkou
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Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
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Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi
Ankara, , Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Fatih, , Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, , Turkey (Türkiye)
Erciyes University School of Medicine
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Countries
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Central Contacts
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Facility Contacts
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Justyna Kwiatkowska-Golańska
Role: backup
Other Identifiers
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2024-513208-32-00
Identifier Type: CTIS
Identifier Source: secondary_id
CDX0159-12
Identifier Type: -
Identifier Source: org_study_id
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