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AzTrials

Chronic Spontaneous UrticariaPhase 3EMBARQ-CSU1NCT06445023

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

A Phase 3 study testing barzolvolimab in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 235 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
barzolvolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
963 participants
Where
235 sitesin 21 countries
Study dates
11 Jul 2024to Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Women who are pregnant or nursing.
  • Chronic urticaria whose predominant manifestation is due to CIndU.
  • Other diseases associated with urticaria.
  • Active pruritic skin condition in addition to CSU.
  • Medical condition that would cause additional risk or interfere with study procedures.
  • Known HIV, hepatitis B or hepatitis C infection.
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  • 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.
  • History of anaphylaxis.
  • Prior treatment with barzolvolimab.
  • There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Trial locations and contacts

235 sites in 21 countries.

235 sites in 21 countries

United States58 sites

  • David Fivenson MD Dermatolgy PLLC

    Ann Arbor, Michigan, 48103

  • Johns Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

  • Cahaba Dermatology Skin Health Center

    Birmingham, Alabama, 35244

  • Paradigm Clinical Research Boise

    Boise, Idaho, 83709

  • Encore Medical Research Boynton Beach

    Boynton Beach, Florida, 33436

  • Apex Clinical Research

    Canton, Ohio, 44718

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236

  • Portland Allergy and Asthma

    Clackamas, Oregon, 97015

  • Finger Lakes Medical Research, PLLC

    Cortland, New York, 13045

  • Alina Clinical Trials

    Dallas, Texas, 75225

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • Wright State Physicians

    Fairborn, Ohio, 45324

  • Auni Allergy

    Findlay, Ohio, 45840

  • First OC Dermatology - Fountain Valley

    Fountain Valley, California, 92708

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave

    Indianapolis, Indiana, 46250

  • 310 Clinical Research

    Inglewood, California, 90301

  • Excel Clinical Research - Las Vegas

    Las Vegas, Nevada, 90301

  • Dermatolgy and Skin Cancer Center

    Lee's Summit, Missouri, 64064

  • Epic Clinical Research

    Lewisville, Texas, 75057

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Focus Clinical Research - Los Angeles

    Los Angeles, California, 91307

  • DS Research of Kentucky, LLC

    Louisville, Kentucky, 40241

  • GSI Clinical Research

    Margate, Florida, 33063

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124

  • Clinical Trials Management LLC - Southshore Office

    Metairie, Louisiana, 70006

  • International Dermatology Research Inc - Miami

    Miami, Florida, 33144

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • Montana Medical Research

    Missoula, Montana, 59808

  • University of Utah - MidValley Dermatology - PPDS

    Murray, Utah, 84107

  • Sadick Research Group

    New York, New York, 10075

  • National Allergy and Asthma Research, LLC - CRN - PPDS

    North Charleston, South Carolina, 29420

  • Allergy Partners of N.J., P.C.

    Ocean City, New Jersey, 07712

  • Allergy Asthma and Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Allergy and Asthma Specialists PSC

    Owensboro, Kentucky, 42301

  • Cura Clinical Research

    Oxnard, California, 93030

  • Clinical Research Philadelphia, LLC

    Philadelphia, Pennsylvania, 18114

  • VAST Clinical Research - Plano

    Plano, Texas, 75033

  • Oregon Medical Research Center

    Portland, Oregon, 97201

  • Allergy and Asthma Consultants

    Redwood City, California, 94063

  • DermAssociates, LLC

    Rockville, Maryland, 20850

  • MediSearch, LLC

    Saint Joseph, Missouri, 64506

  • STAAMP Research, LLC - CRN

    San Antonio, Texas, 78229

  • Acclaim Clinical Research

    San Diego, California, 92120

  • West Dermatology Research Center

    San Diego, California, 92121

  • Therapeutics Clinical Research

    San Diego, California, 92123

  • Sarasota Clinical Research

    Sarasota, Florida, 34239

  • Endeavor Health

    Skokie, Illinois, 60077

  • Premier Clinical Research

    Spokane, Washington, 99202

  • GCP Global Clinical Professionals, LLC

    St. Petersburg, Florida, 33705

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617

  • Orso Health, Inc.

    Torrance, California, 90505

  • Integrated Research of Inland, Inc.

    Upland, California, 91786

  • Allergy and Asthma Care of Waco

    Waco, Texas, 76712

  • Western States Clinical Research Inc

    Wheat Ridge, Colorado, 80033

  • Institute For Asthma and Allergy

    Wheaton, Maryland, 20902

  • Resp Medicine Research Institute of MI

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland26 sites

  • NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"

    Bialystok, 15-453

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

    Bialystok

  • Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Ambulatorium Sp. zo.o.

    Elblag

  • Centrum Badan Klinicznych PI-House Sp. z o.o

    Gdansk, 80-546

  • "SYNEXUS POLSKA" sp. z o.o. Odział w Katowicach

    Katowice, 40-040

  • Centrum Medyczne Katowice - PRATIA - PPDS

    Katowice, 40-081

  • Polimedica PTG Kielce

    Kielce, 25-355

  • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. o.o.

    Krakow, 31-011

  • Santa Familia PTG Łódź

    Lodz, 90-302

  • Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwesytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi

    Lodz

  • Pratia S.A. Centrum Medyczne Pratia Poznań

    Poznan, 60-185

  • Specjalistyczna Przychodnai Lekarska Alergo-Med Sp. z o.o.

    Poznan

  • Synexus Polska Sp. z o.o. - Poznaniu

    Poznan

  • NSZOZ Puls-Med Anna Bogusz, Agnieszka Musielak spolka jawna

    Skarżysko-Kamienna, 26-110

  • Laser Clinic S.C

    Szczecin, 70-332

  • MICS Centrum Medyczne Torun

    Torun, 87-100

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-962

  • FutureMeds - Targowek - PPDS

    Warsaw

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher

    Warsaw

  • Ginemedica

    Wroclaw, 50-414

  • Diagnostic Consultative Center Pulmed

    Wroclaw, 50-566

  • Przychodnia FutureMeds Wroclaw

    Wroclaw, 53-673

  • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

    Wroclaw, 54-144

  • Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o.

    Zabrze

Other trials in Poland

Argentina16 sites

  • Buenos Aires Skin

    Buenos Aires, Buenos Aires, C1054

  • Fundacion Cidea

    Buenos Aires, Buenos Aires, C1121ABE

  • Hospital Italiano De Buenos Aires

    Buenos Aires, Buenos Aires F.D., 1199

  • Centro Médico Vitae

    Buenos Aires

  • Instituto de Alergia e Inmunologia del Sur

    Buenos Aires

  • Conexa Investigacion Clinica

    CABA, Buenos Aires F.D., 1012

  • Aprillus Asistencia e Investigacion

    CABA, Buenos Aires F.D., 1406

  • CARE- Centro de Alergia y Enfermedades Respiratorias

    CABA, Buenos Aires F.D., C14141AIF

  • CEMLO:Centro de Especialidades Medicas Lobos

    Lobos, Buenos Aires, 7240

  • Centro Respiratorio Infantil

    Rosario, Sante Fe, 2000

  • Instituto de Especialidades de Salud Rosario

    Rosario, Sante Fe, 2000

  • Servicio de Investigacion de Patologias Alergicas

    Rosario, Sante Fe, 2000

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, Sante Fe, S2000DEJ

  • C.I.C.E 9 de Julio - Sanatorio 9 de Julio S.A.

    San Miguel de Tucumán, Tucumán Province, 4000

  • Clinica Mayo

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

South Africa13 sites

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1501

  • Iatros International

    Bloemfontein, Free State, 9301

  • Synapta Clinical Research

    Durban, KwaZulu-Natal, 4001

  • Infinity Dermatology Inc

    Durban

  • Ubuntu Clinical Research

    Krugersdorp, Gauteng, 1739

  • University of Cape Town Lung Institute

    Mowbray, Western Cape, 7700

  • Newtown Clinical Research Centre

    Newtown, Gauteng, 2001

  • Meditrial

    Pietermaritzburg

  • About Allergy

    Pretoria, Gauteng, 0181

  • Global Clinical Trials

    Pretoria, 0157

  • Sandton Medical Research Centre

    Sandton

  • FCRN Clinical Trial Centre

    Vereeniging, Gauteng, 1935

  • Allergy and Asthma Centre

    Westville

Other trials in South Africa

Brazil11 sites

  • AlergoAlpha Allergia e Immunologia

    Barueri

  • Instituto de Pesquisas Clínicas LTDA Brasilia

    Brasília

  • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde

    Caxias do Sul

  • Centro Paraibano de Pesquisas e Estudos Clínicos

    João Pessoa

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    Porto Alegre

  • Hospital Universitário Clementino Fraga Filho (UFRJ)

    Rio de Janeiro

  • Clinica IBIS

    Salvador

  • Centro de Estudos de Pneumologia da Faculdade de Medecina do ABC

    Santo André

  • Centro de Pesquisa SVRI Hospital e Maternidade Christóvão da Gama

    Santo André

  • Clínica de Alergia Martti Antila

    São Paulo

  • Vidamed Care Clínica E Residência

    Vitória

Other trials in Brazil

Bulgaria10 sites

  • "Medical center MedTech Services" OOD

    Haskovo, 6304

  • Diagnostic Consultative Center Pulmed

    Plovdiv

  • Aipsimpa D-R Talyat Sali Cholak Eood

    Razgrad, 7200

  • Medical Center Iskar EOOD

    Sofia, 1000

  • MC Excelsior OOD

    Sofia, 1407

  • DCC Fokus - 5 OOD LZIBP

    Sofia, 1463

  • Medical Center Hera EOOD

    Sofia, 1510

  • UMHATEM " N.I.Pirogov"

    Sofia, 1606

  • Medical Center Pulmovision

    Sofia, 1756

  • MBAL Sv. Panteleymon AD

    Yambol, 8600

Other trials in Bulgaria

Germany10 sites

  • Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP - Berlin

    Berlin

  • Studienzentrum an der Hase Weyergraf / Frick / Heiber GbR

    Bramsche, 49565

  • Rosenpark Research GmbH

    Darmstadt, Hesse, 64283

  • ProDerma

    Dülmen, North Rhine-Westphalia, 48249

  • UKSH Kiel

    Kiel, Schleswig-Holstein, 24105

  • Medizinisches Versorgungszentrum DermaKiel GmbH

    Kiel, Schleswig-Holstein, 24148

  • Praxis Dr. Beate Schwarz

    Langenau, Baden-Wurttemberg, 89129

  • Siteworks Prüfzentrum Lohne - PPDS

    Löhne, Lower Saxony, 49393

  • Dermatologie Quist

    Mainz, 55128

  • LMU Klinikum der Universität München

    München

Other trials in Germany

Spain10 sites

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • C.H. Regional Reina Sofia

    Córdoba, 14004

  • Future Meds Madrid

    Madrid, 28002

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 8208

  • Complejo Asistencial Universitario De Salamanca

    Salamanca, 37007

  • Hospital Universitario de la Plana

    Villarreal de Huerva, 12540

Other trials in Spain

Portugal9 sites

  • ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro

    Aveiro

  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243

  • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3004-561

  • Hospital Lusiadas Lisboa

    Lisbon, 1500-458

  • Unidade Local de Saúde de Santa Maria

    Lisbon

  • ULS de Matosinhos, EPE - Hospital Pedro Hispano

    Matosinhos Municipality

  • ULS de Santo António, EPE - Hospital de Santo António

    Porto, 4050-342

  • ULS da Arrábida, EPE - Hospital de São Bernardo

    Setúbal, 2910-548

  • Unidade Local de Saúde de Gaia/Espinho - Unidade I

    Vila Nova de Gaia

Other trials in Portugal

Taiwan9 sites

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu, 300

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • China Medical University Hospital -PPDS

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • MacKay Memorial Hospital -Taipei branch

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

Belgium8 sites

  • UZ Brussel

    Brussels, 1090

  • Saint Luc

    Brussels, 1200

  • CHU de Liège

    Brussels

  • Hôpital Erasme - Erasme Medical Center - PPDS

    Brussels

  • UZ Antwerp

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

  • Dermatologie Maldegem

    Maldegem, 9990

Other trials in Belgium

Canada8 sites

  • Rejuvenation Dermatology and Aesthetics

    Calgary

  • Alberta DermaSurgery Centre - Probity - PPDS

    Edmonton, Alberta

  • Triple A Lab

    Hamilton, Ontario, L8S1G5

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • Centre for Dermatology and Cosmetic Surgery

    Richmond Hill, Ontario, L4B 1A5

  • Skincare Research

    St. John's, Newfoundland and Labrador

  • Canadian Dermatology Centre - Probity - PPDS

    Toronto, Ontario, M3B 0A7

  • Evidence Based Medical Educator Inc.

    Toronto, Ontario, M5G1E2

Other trials in Canada

France7 sites

  • CHU de Grenoble Alpes - Hôpital Michallon

    La Tronche

  • Cabinet du Dr Ruer-Mulard Mireille

    Martigues

  • CHRU Nantes Hôtel Dieu

    Nantes, 44093

  • CHU de Nice-Hôpital L'Archet

    Nice, 06202

  • Hôpital La Pitié Salpêtrière

    Paris, 75013

  • Hospices Civils de Lyon - Hôpital Lyon Sud

    Pierre-Bénite, Rhone, 69310

  • CHRU Rouen - Hôpital Charles-Nicolle

    Rouen

Other trials in France

South Korea7 sites

  • Korea University Ansan Hospital

    Ansan, 15355

  • Hanyang University Seoul Hospital

    Seongdong, Seoul Teugbyesolsi, 40763

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Turkey (Türkiye)7 sites

  • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

    Ankara

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi

    Ankara

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Fatih

  • Kocaeli Universitesi Tip Fakultesi Hastanesi

    Kocaeli

  • Erciyes University School of Medicine

    Melikgazi

  • Ondokuz Mayis University Hospital

    Samsun

  • Karadeniz Teknik Universitesi Tip Fakultesi Hastanesi

    Trabzon

Other trials in Turkey (Türkiye)

Italy6 sites

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, 60128

  • ASST Carlo Poma

    Mantua, 46100

  • Istituti Clinici Scientifici Maugeri IRCCS

    Milan, 20138

  • Azienda Ospedaliera Universitaria Federico II

    Naples

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 20128

  • Centro Ricerche Cliniche Verona s.r.l./Ospedale G.B. Rossi Borgo Roma

    Verona, 37134

Other trials in Italy

Malaysia5 sites

  • Hospital Pulau Pinang

    George Town

  • Hospital Raja Permaisuri Bainun

    Ipoh

  • Hospital Sultan Ismail

    Johor Bahru

  • Hospital Kuala Lumpur

    Kuala Lumpur

  • Hospital Umum Sarawak

    Kuching

Other trials in Malaysia

Czechia4 sites

  • Fakultní nemocnice Královské Vinohrady, Dermatovenerologická klinika

    Prague, 10034

  • Sanatorium profesora Arenbergera

    Prague, 110 00

  • Kožní ambulance Fialová, s.r.o.

    Prague, 160 00

  • Fakultní nemocnice Bulovka, Dermatovenerologická klinika

    Prague, 18081

Other trials in Czechia

Greece4 sites

  • Naval Hospital of Athens

    Athens, 11521

  • Andreas Syggros Hospital

    Athens, 16121

  • Attikon General University Hospital

    Attiki, 12462

  • General Hospital of Thessaloniki 'Papageorgiou'

    Thessaloniki, 56403

Other trials in Greece

Peru4 sites

  • Clinica Internacional - Sede Lima

    Lima

  • Clinica Ricardo Palma

    Lima

  • Clinica San Felipe

    Lima

  • Medic Ser S.A.C. Auna Clinica Delgado

    Lima

Other trials in Peru

Denmark3 sites

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Bispebjerg Hospital

    Copenhagen NV, 2400

  • Gentofte Hospital

    Hellerup, 2900

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
barzolvolimab, Matching placebo
Keywords
CDX-0159, barzolvolimab, chronic spontaneous urticaria, CSU, urticaria activity score, itch severity score, hives severity score
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • barzolvolimabBiological

    Subcutaneous Administration

  • Matching placeboBiological

    Matching placebo Subcutaneous Administration

Study groups in NCT06445023
Study groupRoleWhat they receive
barzolvolimab 150 mgExperimentalbarzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Receives: Biological: barzolvolimab
barzolvolimab 300 mgExperimentalbarzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Receives: Biological: barzolvolimab
Placebo then barzolvolimab 150 mgExperimentalPlacebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
Receives: Biological: barzolvolimab; Biological: Matching placebo
Placebo then barzolvolimab 300 mgExperimentalPlacebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
Receives: Biological: barzolvolimab; Biological: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

    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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

Secondary outcomes (8)

  1. Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)

    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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  2. Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)

    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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  3. Percentage of participants with UAS7 = 0 at Week 12

    Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  4. Percentage of participants with UAS7 ≤ 6 at Week 12

    Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7≤6) at Week 12.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  5. Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at 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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  6. Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at 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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  7. Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at 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.

    Measured: From Day 1 (first dose) to Day 85 (Week 12)

  8. Incidence of Treatment-Emergent Adverse Events

    Occurrence of treatment emergent adverse events and serious adverse events during the study.

    Measured: From Day 1 (first dose) to Day 477 (Week 68)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start11 Jul 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
963 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06445023
Sponsor's protocol ID
CDX0159-12
Other IDs
2024-513208-32-00
Acronym
EMBARQ-CSU1
Status last verified
Mar 2026
First submitted
31 May 2024
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing barzolvolimab in people with Chronic Spontaneous Urticaria, run by Celldex Therapeutics at 235 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Poland, Argentina, South Africa, Brazil and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) (time frame: From Day 1 (first dose) to Day 85 (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06445023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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