A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (EMBARQ-CSU1)

March 24, 2026 updated by: Celldex Therapeutics

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.

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.

Study Type

Interventional

Enrollment (Actual)

963

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Centro Médico Vitae
      • Buenos Aires, Argentina
        • Instituto de Alergia e Inmunologia del Sur
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, C1054
        • Buenos Aires Skin
      • Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Fundacion Cidea
      • Lobos, Buenos Aires, Argentina, 7240
        • CEMLO:Centro de Especialidades Medicas Lobos
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1199
        • Hospital Italiano de Buenos Aires
      • CABA, Buenos Aires F.D., Argentina, 1406
        • APRILLUS Asistencia e Investigacion
      • CABA, Buenos Aires F.D., Argentina, 1012
        • Conexa Investigacion Clinica
      • CABA, Buenos Aires F.D., Argentina, C14141AIF
        • Care- Centro de Alergia y Enfermedades Respiratorias
    • Sante Fe
      • Rosario, Sante Fe, Argentina, 2000
        • Centro Respiratorio Infantil
      • Rosario, Sante Fe, Argentina, 2000
        • Instituto de Especialidades de Salud Rosario
      • Rosario, Sante Fe, Argentina, 2000
        • Servicio de Investigacion de Patologias Alergicas
      • Rosario, Sante Fe, Argentina, S2000DEJ
        • Instituto Medico de La Fundacion Estudios Clinicos
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • C.I.C.E 9 de Julio - Sanatorio 9 de Julio S.A.
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Clinica Mayo
  • Belgium
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1200
        • Saint Luc
      • Brussels, Belgium
        • CHU de Liege
      • Brussels, Belgium
        • Hôpital Erasme - Erasme Medical Center - PPDS
      • Ghent, Belgium, 9000
        • UZ Gent
      • Maldegem, Belgium, 9990
        • Dermatologie Maldegem
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerp
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven
  • Brazil
      • Barueri, Brazil
        • AlergoAlpha Allergia e Immunologia
      • Brasília, Brazil
        • Instituto de Pesquisas Clínicas LTDA Brasilia
      • Caxias do Sul, Brazil
        • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
      • João Pessoa, Brazil
        • Centro Paraibano de Pesquisas e Estudos Clínicos
      • Porto Alegre, Brazil
        • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
      • Rio de Janeiro, Brazil
        • Hospital Universitário Clementino Fraga Filho (UFRJ)
      • Salvador, Brazil
        • Clinica Ibis
      • Santo André, 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
      • São Paulo, Brazil
        • Clinica de Alergia Martti Antila
      • Vitória, Brazil
        • Vidamed Care Clínica E Residência
  • Bulgaria
      • Haskovo, Bulgaria, 6304
        • "Medical center MedTech Services" OOD
      • Plovdiv, Bulgaria
        • Diagnostic Consultative Center Pulmed
      • Razgrad, Bulgaria, 7200
        • Aipsimpa D-R Talyat Sali Cholak Eood
      • Sofia, Bulgaria, 1510
        • Medical Center Hera EOOD
      • Sofia, Bulgaria, 1000
        • Medical Center Iskar EOOD
      • Sofia, Bulgaria, 1407
        • MC Excelsior OOD
      • Sofia, Bulgaria, 1463
        • DCC Fokus - 5 OOD LZIBP
      • Sofia, Bulgaria, 1606
        • UMHATEM " N.I.Pirogov"
      • Sofia, Bulgaria, 1756
        • Medical Center Pulmovision
      • Yambol, Bulgaria, 8600
        • MBAL Sv. Panteleymon AD
  • Canada
      • Calgary, Canada
        • Rejuvenation Dermatology and Aesthetics
    • Alberta
      • Edmonton, Alberta, Canada
        • Alberta DermaSurgery Centre - Probity - PPDS
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Skincare Research
    • Ontario
      • Hamilton, Ontario, Canada, L8S1G5
        • Triple A Lab
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • Centre for Dermatology and Cosmetic Surgery
      • Toronto, Ontario, Canada, M3B 0A7
        • Canadian Dermatology Centre - Probity - PPDS
      • Toronto, Ontario, Canada, M5G1E2
        • Evidence Based Medical Educator Inc.
  • Czechia
      • Prague, Czechia, 110 00
        • Sanatorium Profesora Arenbergera
      • Prague, Czechia, 10034
        • Fakultní nemocnice Královské Vinohrady, Dermatovenerologická klinika
      • Prague, Czechia, 160 00
        • Kožní ambulance Fialová, s.r.o.
      • Prague, Czechia, 18081
        • Fakultní nemocnice Bulovka, Dermatovenerologická klinika
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital
      • Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
  • France
      • La Tronche, France
        • CHU de Grenoble Alpes - Hôpital Michallon
      • Martigues, France
        • Cabinet du Dr Ruer-Mulard Mireille
      • Nantes, France, 44093
        • CHRU Nantes Hôtel Dieu
      • Nice, France, 06202
        • CHU de Nice-Hôpital L'Archet
      • Paris, France, 75013
        • Hôpital La Pitié Salpêtrière
      • Rouen, France
        • CHRU Rouen - Hôpital Charles-Nicolle
    • Rhone
      • Pierre-Bénite, Rhone, France, 69310
        • Hospices Civils de Lyon - Hôpital Lyon Sud
  • Germany
      • Berlin, Germany
        • Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP - Berlin
      • Bramsche, Germany, 49565
        • Studienzentrum an der Hase Weyergraf / Frick / Heiber GbR
      • Mainz, Germany, 55128
        • Dermatologie Quist
      • München, Germany
        • LMU Klinikum der Universität München
    • Baden-Wurttemberg
      • Langenau, Baden-Wurttemberg, Germany, 89129
        • Praxis Dr. Beate Schwarz
    • Hesse
      • Darmstadt, Hesse, Germany, 64283
        • Rosenpark Research GmbH
    • Lower Saxony
      • Löhne, Lower Saxony, Germany, 49393
        • Siteworks Prüfzentrum Lohne - PPDS
    • North Rhine-Westphalia
      • Dülmen, North Rhine-Westphalia, Germany, 48249
        • ProDerma
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • UKSH Kiel
      • Kiel, Schleswig-Holstein, Germany, 24148
        • Medizinisches Versorgungszentrum DermaKiel GmbH
  • Greece
      • Athens, Greece, 11521
        • Naval Hospital of Athens
      • Athens, Greece, 16121
        • Andreas Syggros Hospital
      • Attiki, Greece, 12462
        • Attikon General University Hospital
      • Thessaloniki, Greece, 56403
        • General Hospital of Thessaloniki 'Papageorgiou'
  • Italy
      • Ancona, Italy, 60128
        • Azienda Ospedaliero Universitaria delle Marche
      • Mantova, Italy, 46100
        • ASST Carlo Poma
      • Milan, Italy, 20138
        • Istituti Clinici Scientifici Maugeri IRCCS
      • Naples, Italy
        • Azienda Ospedaliera Universitaria Federico II
      • Torino, Italy, 20128
        • Azienda Ospedaliera Ordine Mauriziano di Torino
      • Verona, Italy, 37134
        • Centro Ricerche Cliniche Verona s.r.l./Ospedale G.B. Rossi Borgo Roma
  • Malaysia
      • George Town, Malaysia
        • Hospital Pulau Pinang
      • Ipoh, Malaysia
        • Hospital Raja Permaisuri Bainun
      • Johor Bahru, Malaysia
        • Hospital Sultan Ismail
      • Kuala Lumpur, Malaysia
        • Hospital Kuala Lumpur
      • Kuching, Malaysia
        • Hospital Umum Sarawak
  • Peru
      • Lima, Peru
        • Clinica Ricardo Palma
      • Lima, Peru
        • Clinica San Felipe
      • Lima, Peru
        • Clinica Internacional - Sede Lima
      • Lima, Peru
        • Medic Ser S.A.C. Auna Clinica Delgado
  • Poland
      • Bialystok, Poland, 15-453
        • Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"
      • Bialystok, Poland
        • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk
      • Bydgoszcz, Poland, 85-796
        • Pratia Bydgoszcz
      • Elblag, Poland
        • Ambulatorium Sp. zo.o.
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House Sp. z o.o
      • Katowice, Poland, 40-081
        • Centrum Medyczne Katowice - PRATIA - PPDS
      • Katowice, Poland, 40-040
        • "SYNEXUS POLSKA" sp. z o.o. Odział w Katowicach
      • Kielce, Poland, 25-355
        • Polimedica PTG Kielce
      • Krakow, Poland, 31-011
        • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. o.o.
      • Lodz, Poland, 90-302
        • 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
      • Poznan, Poland, 60-185
        • 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
      • Skarżysko-Kamienna, Poland, 26-110
        • NSZOZ Puls-Med Anna Bogusz, Agnieszka Musielak spolka jawna
      • Szczecin, Poland, 70-332
        • Laser Clinic S.C
      • Torun, Poland, 87-100
        • MICS Centrum Medyczne Torun
      • Warsaw, Poland, 02-962
        • Royalderm Agnieszka Nawrocka
      • Warsaw, Poland, 02-953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Poland
        • FutureMeds - Targowek - PPDS
      • Warsaw, Poland
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
      • Wroclaw, Poland, 54-144
        • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
      • Wroclaw, Poland, 50-414
        • Ginemedica
      • Wroclaw, Poland, 50-566
        • Diagnostic Consultative Center Pulmed
      • Wroclaw, Poland, 53-673
        • Przychodnia FutureMeds Wroclaw
      • Zabrze, Poland
        • Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o.
  • Portugal
      • Aveiro, Portugal
        • ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico, Braga - Hospital de Braga
      • Coimbra, Portugal, 3004-561
        • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
      • Lisbon, Portugal, 1500-458
        • Hospital Lusíadas Lisboa
      • Lisbon, Portugal
        • Unidade Local de Saúde de Santa Maria
      • Matosinhos Municipality, Portugal
        • ULS de Matosinhos, EPE - Hospital Pedro Hispano
      • Porto, Portugal, 4050-342
        • ULS de Santo António, EPE - Hospital de Santo António
      • Setúbal, Portugal, 2910-548
        • ULS da Arrábida, EPE - Hospital de São Bernardo
      • Vila Nova de Gaia, Portugal
        • Unidade Local de Saúde de Gaia/Espinho - Unidade I
  • South Africa
      • Durban, South Africa
        • Infinity Dermatology Inc
      • Pietermaritzburg, South Africa
        • Meditrial
      • Pretoria, South Africa, 0157
        • Global Clinical Trials
      • Sandton, South Africa
        • Sandton Medical Research Centre
      • Westville, South Africa
        • Allergy and Asthma Centre
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Iatros International
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
        • Worthwhile Clinical Trials
      • Krugersdorp, Gauteng, South Africa, 1739
        • Ubuntu Clinical Research
      • Newtown, Gauteng, South Africa, 2001
        • Newtown Clinical Research Centre
      • Pretoria, Gauteng, South Africa, 0181
        • About Allergy
      • Vereeniging, Gauteng, South Africa, 1935
        • FCRN Clinical Trial Centre
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Synapta Clinical Research
    • Western Cape
      • Mowbray, Western Cape, South Africa, 7700
        • University of Cape Town Lung Institute
  • South Korea
      • Ansan, South Korea, 15355
        • Korea University Ansan Hospital
      • Seongnam-si, South Korea
        • Seoul National University Bundang Hospital
      • Seongnam-si, South Korea, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Suwon, South Korea, 16499
        • Ajou University Hospital
    • Seoul Teugbyesolsi
      • Seongdong, Seoul Teugbyesolsi, South Korea, 40763
        • Hanyang University Seoul Hospital
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario Dr. Balmis
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28002
        • Future Meds Madrid
      • Salamanca, Spain, 37007
        • Complejo Asistencial Universitario de Salamanca
      • Villarreal de Huerva, Spain, 12540
        • Hospital Universitario de La Plana
    • Barcelona
      • Sabadell, Barcelona, Spain, 8208
        • Corporacio Sanitaria Parc Tauli
  • Taiwan
      • Hsinchu, Taiwan, 300
        • National Taiwan University Hospital Hsin-Chu Branch
      • Kaohsiung City, Taiwan
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan
        • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital -PPDS
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • MacKay Memorial Hospital -Taipei branch
      • Taoyuan District, Taiwan
        • Chang Gung Memorial Hospital, Linkou
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
      • Ankara, Turkey (Türkiye)
        • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi
      • Fatih, Turkey (Türkiye)
        • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli Universitesi Tip Fakultesi Hastanesi
      • Melikgazi, Turkey (Türkiye)
        • Erciyes University School of Medicine
      • Samsun, Turkey (Türkiye)
        • Ondokuz Mayis University Hospital
      • Trabzon, Turkey (Türkiye)
        • Karadeniz Teknik Universitesi Tip Fakultesi Hastanesi
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology Skin Health Center
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology - Fountain Valley
      • Inglewood, California, United States, 90301
        • 310 Clinical Research
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Los Angeles, California, United States, 91307
        • Focus Clinical Research - Los Angeles
      • Oxnard, California, United States, 93030
        • Cura Clinical Research
      • Redwood City, California, United States, 94063
        • Allergy and Asthma Consultants
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Diego, California, United States, 92120
        • Acclaim Clinical Research
      • San Diego, California, United States, 92121
        • West Dermatology Research Center
      • Torrance, California, United States, 90505
        • Orso Health, Inc.
      • Upland, California, United States, 91786
        • Integrated Research of Inland, Inc.
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research Inc
    • Florida
      • Boynton Beach, Florida, United States, 33436
        • Encore Medical Research Boynton Beach
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Margate, Florida, United States, 33063
        • Gsi Clinical Research
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research Institute, LLC
      • Miami, Florida, United States, 33144
        • International Dermatology Research Inc - Miami
      • Sarasota, Florida, United States, 34239
        • Sarasota Clinical Research
      • St. Petersburg, Florida, United States, 33705
        • GCP Global Clinical Professionals, LLC
    • Idaho
      • Boise, Idaho, United States, 83709
        • Paradigm Clinical Research Boise
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Endeavor Health
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • DS Research of Kentucky, LLC
      • Owensboro, Kentucky, United States, 42301
        • Allergy and Asthma Specialists PSC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management LLC - Southshore Office
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Asthma and Allergy Center
      • Rockville, Maryland, United States, 20850
        • DermAssociates, LLC
      • Wheaton, Maryland, United States, 20902
        • Institute for Asthma and Allergy
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson MD Dermatolgy PLLC
      • Ypsilanti, Michigan, United States, 48197
        • Resp Medicine Research Institute of MI
    • Missouri
      • Lee's Summit, Missouri, United States, 64064
        • Dermatolgy and Skin Cancer Center
      • Saint Joseph, Missouri, United States, 64506
        • Medisearch, LLC
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • Nevada
      • Las Vegas, Nevada, United States, 90301
        • Excel Clinical Research - Las Vegas
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Allergy Partners of N.J., P.C.
    • New York
      • Cortland, New York, United States, 13045
        • Finger Lakes Medical Research, PLLC
      • New York, New York, United States, 10075
        • Sadick Research Group
    • Ohio
      • Bexley, Ohio, United States, 43209
        • Bexley Dermatology Research
      • Canton, Ohio, United States, 44718
        • Apex Clinical Research
      • Cincinnati, Ohio, United States, 45236
        • Bernstein Clinical Research Center, LLC
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians
      • Findlay, Ohio, United States, 45840
        • Auni Allergy
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center
      • Toledo, Ohio, United States, 43617
        • Toledo Institute of Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy Asthma and Clinical Research Center
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Portland Allergy and Asthma
      • Portland, Oregon, United States, 97201
        • Oregon Medical Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 18114
        • Clinical Research Philadelphia, LLC
    • South Carolina
      • North Charleston, South Carolina, United States, 29420
        • National Allergy and Asthma Research, LLC - CRN - PPDS
    • Texas
      • Dallas, Texas, United States, 75230
        • Zenos Clinical Research
      • Dallas, Texas, United States, 75225
        • Alina Clinical Trials
      • Lewisville, Texas, United States, 75057
        • EPIC Clinical Research
      • Plano, Texas, United States, 75033
        • VAST Clinical Research - Plano
      • San Antonio, Texas, United States, 78229
        • STAAMP Research, LLC - CRN
      • Waco, Texas, United States, 76712
        • Allergy and Asthma Care of Waco
    • Utah
      • Murray, Utah, United States, 84107
        • University of Utah - MidValley Dermatology - PPDS
    • Washington
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Males and females, >/= 18 years of age.
  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.

Key Exclusion Criteria:

  1. Women who are pregnant or nursing.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: barzolvolimab 150 mg
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Biological: barzolvolimab
Subcutaneous Administration
Experimental: barzolvolimab 300 mg
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Biological: barzolvolimab
Subcutaneous Administration
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.
Biological: barzolvolimab
Subcutaneous Administration
Biological: Matching placebo
Matching placebo Subcutaneous Administration
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.
Biological: barzolvolimab
Subcutaneous Administration
Biological: Matching placebo
Matching placebo Subcutaneous Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)

Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).

The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
From Day 1 (first dose) to Day 85 (Week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The ISS7 is the itch severity score for 7 days, the scores range from 0 to 21.
From Day 1 (first dose) to Day 85 (Week 12)
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days, the scores range from 0 to 21.
From Day 1 (first dose) to Day 85 (Week 12)
Percentage of participants with UAS7 = 0 at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.
From Day 1 (first dose) to Day 85 (Week 12)
Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)

Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) in participants who did not respond to or did not tolerate omalizumab.

The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12 in participants who did not respond to or did not tolerate omalizumab.
From Day 1 (first dose) to Day 85 (Week 12)
Incidence of Treatment-Emergent Adverse Events
Time Frame: From Day 1 (first dose) to Day 477 (Week 68)
Occurrence of treatment emergent adverse events and serious adverse events during the study.
From Day 1 (first dose) to Day 477 (Week 68)
Percentage of participants with UAS7 ≤ 6 at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)
Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7≤6) at Week 12.
From Day 1 (first dose) to Day 85 (Week 12)
Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at Week 12
Time Frame: From Day 1 (first dose) to Day 85 (Week 12)

Proportion of participants with AAS7 > 0 at Day 1 who achieved complete control (AAS7 = 0) at Week 12

Angioedema Activity Score over 7 days [AAS7] describes the effect of angioedema on five categories with 0 being none and 3 being most severe. The final score is calculated by adding together daily scores which can range from 0-15 for 7 days. The resulting maximum score is then 105.
From Day 1 (first dose) to Day 85 (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX0159-12
  • 2024-513208-32-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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