AzTrials
AzTrials

Chronic Spontaneous UrticariaPhase 3NCT07256392

Long-term Efficacy and Safety Extension (LTE) 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 201 sites in 30 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. 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?
No, everyone receives an active treatment
How many people
1,370 participants
Where
201 sitesin 30 countries
Study dates
25 Nov 2025to Sep 2028
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

  • Written informed consent
  • Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).
  • Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment.
  • Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary.

Who cannot join

  • Active pruritic skin condition in addition to CSU.
  • Medical condition that would cause additional risk or interfere with study procedures.
  • Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials.
  • There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Trial locations and contacts

201 sites in 30 countries. Contact the study team or a site near you to ask about taking part.

201 sites in 30 countries

United States45 sites

  • Kern Research

    Bakersfield, California, 93301

  • John Hopkins University

    Baltimore, Maryland, 21224

  • Bexley Dermatology Research

    Bexley, Ohio, 43209

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham, Alabama, 35244

  • Encore Medical Research of Boynton Beach LLC

    Boynton Beach, Florida, 33436

  • The Derm Institute of West Michigan

    Caledonia, Missouri, 49316-7478

  • Portland Allergy and Asthma

    Clackamas, Oregon, 97015

  • Michigan Center for Research Co., LLC

    Clarkston, Michigan, 48346

  • Asthma and Allergy Associates

    Colorado Springs, Colorado, 80907

  • Centricity Research Columbus Dermatology

    Columbus, Georgia, 31904

  • Alina Clinical Trials LLC

    Dallas, Texas, 75225

  • Dolphin Medical Research

    Doral, Florida, 33172

  • Western Sky Medical Research

    El Paso, Texas, 79912

  • Auni Allergy

    Findlay, Ohio, 45840

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919

  • Allergy and Asthma Associates of Southern California - Laguna Niguel - CRN

    Laguna Niguel, California, 92677

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • LA Universal Research Center, Inc.

    Los Angeles, California, 90057

  • GSI Clinical Research

    Margate, Florida, 33063

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • Deluxe Health Center

    Miami Lakes, Florida, 33014

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • University of Utah MidValley Dermatology

    Murray, Utah, 84107

  • Markowitz Medical PLLC dba OptiSkin Medical

    New York, New York, 10128

  • Allergy Partners of NJ, PC

    Ocean City, New Jersey, 07712

  • Skin Specialists, PC dba Schlessinger MD

    Omaha, Nebraska, 68144

  • Allergy and Asthma Specialists PSC

    Owensboro, Kentucky, 42301

  • DermAssociates, LLC

    Rockville, Maryland, 20850

  • Rainey & Finklea San Antonio (RFSA) Dermatology

    San Antonio, Texas, 78213

  • Allergy Associates of Utah

    Sandy City, Utah, 84093

  • Sarasota Clinical Research

    Sarasota, Florida, 34239

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251

  • Center for Dermatology & Plastic Surgery - Avacare

    Scottsdale, Arizona, 85260

  • Endeavor Health

    Skokie, Illinois, 60026

  • The South Bend Clinic - Avacare

    South Bend, Indiana, 46617

  • Midwest Clinical Research

    St Louis, Missouri, 63141

  • Washington University School of Medicine

    St Louis, Missouri, 63141

  • GCP, Global Clinical Professionals

    St. Petersburg, Florida, 33705

  • Advanced Clinical Research Institute (ACRI) - Florida

    Tampa, Florida, 33607

  • Toledo Institute for Clinical Research

    Toledo, Ohio, 43617

  • Allergy and Asthma Care of Waco

    Waco, Texas, 76712

  • Kalo Clinical Research

    West Valley City, Utah, 84120

  • Institute for Asthma and Allergy

    Wheaton, Maryland, 20902

  • Respiratory Medicine Research Institute of Michigan PLC

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland25 sites

  • NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL" S.C.

    Bialystok, 15-453

  • Centrum Medyczne PRATIA Częstochowa

    Częstochowa, 42-217

  • Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.

    Elblag, 82-300

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80-382

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

    Gdansk, 80-546

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-040

  • Pratia S.A.

    Katowice, 40-081

  • Centrum Medyczne All-Med Badania Kliniczne

    Krakow, 30-033

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

    Krakow, 31-011

  • LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n med. Dorota Krasowska

    Lublin, 20-753

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • Pratia S.A

    Poznan, 60-185

  • Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen

    Poznan, 60-693

  • EMed Centrum Uslug Medycznych

    Rzeszów, 35-205

  • Niepubliczny Specjalistyczny Zaklad Opieki ZdrowotnejPuls-Med Anna Bogusz Agnieszka Musielak Sp. j.

    Skarżysko-Kamienna, 26-110

  • Laser Clinic S.C.

    Szczecin, 70-332

  • ALERGO-MED Osrodek Badan Klinicznych Sp. z o. o.

    Tarnów, 33-100

  • MICS Centrum Medyczne Toruń

    Torun, 87-100

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, 02-672

  • ETG Warszawa Sp. z o.o.

    Warsaw, 02-677

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953

  • Royalderm

    Warsaw, 02-962

  • Ginemedica Sp. z o.o.

    Wroclaw, 50-414

  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, 50-566

  • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

    Wroclaw, 54-144

Other trials in Poland

Bulgaria16 sites

  • Medical Centre Asklepii OOD

    Dupnitsa, 2600

  • Medical Center Pulmo - 2018 EOOD

    Haskovo, 6300

  • Medical Center Medtech Services EOOD

    Haskovo, 6304

  • Medical Center Medconsult Pleven OOD

    Lovech, 5500

  • Outpatient Clinic for IP for Specialized Outpatient Medical Care in Allergology-Dr.Cholak

    Razgrad, 7200

  • Medical Center Prolet EOOD

    Rousse, 7000

  • Medical Center Iskar EOOD

    Sofia, 1000

  • Diagnostic and Consultative Center Ascendent EOOD

    Sofia, 1202

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    Sofia, 1431

  • Diagnostic and Consultative Center Focus-5 - Medical Establishment for Outpatient care OOD

    Sofia, 1463

  • Medical Center Hera EOOD

    Sofia, 1510

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N. I. Pirogov" EAD, Multiprofile Emergency Department, Allergology room

    Sofia, 1606

  • Diagnostic-Consultative Center Convex EOOD

    Sofia, 1680

  • Medical Center Pulmovision

    Sofia, 1756

  • MBAL Sv. Panteleymon AD - Yambol

    Yambol, 8600

Other trials in Bulgaria

Canada11 sites

  • Alberta DermaSurgery Centre - Probity - PPDS

    Edmonton, Alberta, T6G 1C3

  • Vida Clinical Research

    Edmonton, Alberta, T6H 4J8

  • LEADER research

    Hamilton, Ontario, L8L 3C3

  • Triple A Lab, Inc.

    Hamilton, Ontario, L8S1G5

  • Kingston Health Science Centre

    Kingston, K7L 2V7

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • North Bay Dermatology Centre

    North Bay, Ontario, P1B 3Z7

  • Centre de Recherche Saint-Louis

    Québec, G1W4R4

  • North York Research Inc.

    Toronto, Ontario, M2N 3A6

  • Evidence Based Medical Educator Inc.

    Toronto, Ontario, M5G1E2

  • Joel Liem Medicine Professional Corporation

    Windsor, Ontario, N8X 2G1

Other trials in Canada

Argentina10 sites

  • Fundación CIDEA

    Buenos Aires, Buenos Aires, C1121ABE

  • Conexa Investigación Clínica S.A.

    CABA, Buenos Aires F.D., 1012

  • Aprillus Asistencia e Investigacion

    CABA, Buenos Aires F.D., 1406

  • CEMLO - Centro de Especialidades Médicas Lobos

    Lobos, Buenos Aires, 7240

  • Centro de Investigaciones Clinicas - Instituto Especialidades de la Salud Rosario

    Rosario, Sante Fe, 2000

  • Centro Respiratorio Infantil

    Rosario, Sante Fe, 2000

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Sante Fe, S2000DEJ

  • Clinica Mayo de U.M.C.B.

    San Miguel de Tucumán, Tucumán Province, 4000

  • Sanatorio 9 de Julio

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucumán, Tucumán Province, T4000AXL

Other trials in Argentina

India10 sites

  • Assured Care Plus Hospital

    Kanpur, Uttar Pradesh, 208002

  • KR Hospital, Mysore Medical College and Research Institute

    Mysore, Karnataka, 570001

  • Shree Hospital & Critical Care Centre

    Nagpur, Maharashtra, 440009

  • Assured Care Plus Hospital

    Nashik, Maharashtra, 422101

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra, 411004

  • Oyster& Pearl Hospitals (Phadnis Clinic Pvt Ltd)

    Pune, Maharashtra, 411005

  • Nirmal Hospital - Surat

    Surat, Gujarat, 395002

  • Badoda Medical College and SSG Hospital - Vadodara

    Vadodara, Gujarat, 390001

  • "Dhiraj Hospital, SBKS MI & RC, Sumandeep Vidyapeeth Deemed to be University"

    Vadodara, Gujarat, 391760

  • Sumandeep Vidyapeeth University - Dhiraj Hospital

    Vadodara, Gujarat, 391760

Other trials in India

Germany8 sites

  • Fachklinik Bad Bentheim, Dept. of Dermatology, Klinisches Studienzentrum

    Bad Bentheim, 48455

  • Rosenpark Research GmbH

    Darmstadt, Hesse, 64283

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • ProDerma, Dr. Rolf Dominicus

    Dülmen, North Rhine-Westphalia, 48249

  • Universitatsklinikum Schleswig-Holstein - Kiel

    Kiel, Schleswig-Holstein, 24105

  • MVZ DermaKiel GmbH

    Kiel, Schleswig-Holstein, 24148

  • Dermatologie Quist

    Mainz, 55128

  • Universitäts-Hautklinik Tübingen, Studienzentrum Immundermatologie

    Tübingen, 72076

Other trials in Germany

Spain8 sites

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Vall d'Hebron

    Barcelona, 8035

  • Hospital Universitario Puerta del Mar

    Barcelona, 8036

  • C.H. Regional Reina Sofia

    Córdoba, 14004

  • Hospital Clinico San Carlos - Lopez Bran

    Madrid, 28040

  • Corporació Sanitaria Parc Taulí

    Sabadell, 8208

  • Hospital Universitario de La Plana

    Villarreal de Huerva, 12540

Other trials in Spain

Taiwan8 sites

  • National Taiwan University Hospital - Hsin-Chu Branch

    Hsinchu, 300

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813414

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10048

  • MacKay Memorial Hospital

    Taipei, 10449

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

South Africa7 sites

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1501

  • IATROS International

    Bloemfontein, Free State, 9301

  • Synapta Clinical Research Centre

    Durban, KwaZulu-Natal, 4001

  • University of Cape Town Lung Institute (UCTLI)

    Mowbray, Western Cape, 7700

  • Newtown Clinical Research Centre

    Newtown, Gauteng, 2001

  • Global Clinical Trials (Pty) Ltd - Pretoria

    Pretoria, Gauteng, 0157

  • About Allergy

    Pretoria, Gauteng, 0181

Other trials in South Africa

Chile6 sites

  • Hospital Base San Jose de Osorno

    Osorno

  • Enroll SpA

    Providencia, 7500000

  • Clinica Davila - Recoleta

    Recoleta, 8420000

  • Centro Internacional de Estudios Clinicos (CIEC)

    Recoleta, 8420383

  • Biocinetic Servicios Medicos Ltda

    Santiago, 8350595

  • Clínica Dermacross S.A.

    Vitacura, 7630000

Other trials in Chile

Malaysia5 sites

  • Hospital Pulau Pinang

    George Town, 10450

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • Hospital Umum Sarawak

    Kuching, 93586

Other trials in Malaysia

Portugal5 sites

  • Unidade Local de Saude da Região de Aveiro, E.P.E. - Hospital Infante D. Pedro

    Aveiro, 3814-501

  • Unidade Local De Satide De Coimbra E.P.E.

    Coimbra, 3004-561

  • Hospital Lusíadas Lisboa

    Lisbon, 1500-458

  • Unidade Local de Satide de Santa Maria E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Hospital de São Bernardo, Unidade Local de Saúde da Arrábida (ULSA)

    Setúbal, 2910-548

Other trials in Portugal

United Kingdom5 sites

  • Southmead Hospital, North Bristol NHS Trust

    Bristol, BS10 5NB

  • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde

    Glasgow, G51 4TF

  • St James's University Hospital, The Leeds Teaching Hospitals NHS Trust

    Leeds, West Yorkshire, LS9 7TF

  • Velocity Clinical Research, North London

    North Finchley, N12 8BU

Other trials in United Kingdom

South Korea4 sites

  • Korea University Ansan Hospital

    Ansan, 15355

  • Seoul National University Hospital

    Seoul, 3080

  • Hanyang University Seoul Hospital

    Seoul, 4763

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Australia3 sites

  • Novatrials

    Charlestown, New South Wales, 2290

  • Cornerstone Dermatology

    Coorparoo, QSL, 4151

  • The Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

France3 sites

  • CHRU Nantes Hôtel Dieu

    Nantes, 44093

  • CHU de Nice-Hôpital L'Archet

    Nice, 06202

  • CHU de Nice. Hôpital L'Archet 2

    Nice, 6202

Other trials in France

Georgia3 sites

  • D. Abuladze Georgian-Italian Clinic

    Tbilisi, 0179

  • Healthy Future

    Tbilisi, 119

  • Center of Allergy and Immunology - Gotua

    Tbilisi, 159

Other trials in Georgia

Italy3 sites

  • ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

    Milan, 20157

  • IRCCS Policlinico San Donato

    San Donato Milanese, Lombardy, 20097

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 20128

Other trials in Italy

Thailand3 sites

  • Siriraj Hospital Mahidol University

    Bangkok Noi, 10700

  • Faculty of Medicine, Thammasat University

    Khlong Luang, 12120

  • Chiang Mai University

    Muang Chiang Mai, 50200

Other trials in Thailand

Denmark2 sites

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Gentofte Hospital, Department of Dermatology and Allergy

    Hellerup, 2900

Other trials in Denmark

Greece2 sites

  • Hospital of Venereal and Dermatological Diseases Andreas Syggros, 1st Department of Dermatology and Venereology NKUA

    Athens, 16121

  • "University General Hospital ""ATTIKON""- General Hospital of West Attica ""H AGIA VARVARA"", Allergy Unit, Allergy Unit ""Dimitrios Kalogeromitros"", 2nd Department of Dermatology & Venereology NKUA"

    Chaïdári, Attica, 12462

Other trials in Greece

Slovakia2 sites

  • Derma therapy spol. s r.o., Dermatovenerologicka ambulancia

    Bratislava, 85101

  • Alersa s.r.o.

    Košice, 4022

Other trials in Slovakia

Belgium1 site

  • Cliniques Universitaires Saint-Luc - PPDS

    Brussels, 1200

Other trials in Belgium

Colombia1 site

  • Centro de Inmunologia y Genetica CIGE S.A.S.

    Medellín, 50012

Other trials in Colombia

Czechia1 site

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

Other trials in Czechia

Hungary1 site

  • Allergo-Derm Bakos Kft.

    Szolnok, 5000

Other trials in Hungary

Lithuania1 site

  • CD8 Klinika UAB

    Kaunas, LT-44192

Other trials in Lithuania

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Tunisia1 site

  • Faculte de Medecine de Sfax - CHU Hedi Chaker

    Sfax, 3000

Other trials in Tunisia

About this study

Official title: A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials.

This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Read the detailed description

This is a global, multicenter, long-term extension phase 3b study to determine the time to disease worsening or treatment failure in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods the phase 3 clinical trials.

The study will consist of 2 Groups: Group 1 (Observation Group), comprising participants whose UAS7 score is less than 16 at entry and Group 2 (Barzolvolimab Retreatment Group) comprising participants whose UAS7 score is 16 or greater.

Participation in this trial will last for approximately 52 weeks for participants assigned to Group 1 (Observation Group) and who do not receive barzolvolimab during the trial. Participants assigned to Group 1 who require barzolvolimab rescue during the trial will be in the trial for up to 68 weeks. Participants assigned to Group 2 (Barzolvolimab Retreatment Group), trial participation will last for approximately 68 weeks from the start of treatment (Day 1).

Being tested
barzolvolimab, Standard of Care
Keywords
CDX-0159, barzolvolimab, chronic spontaneous urticaria, CSU, urticaria activity score, itch 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

  • Standard of CareOther

    Observational/Standard of Care

Study groups in NCT07256392
Study groupRoleWhat they receive
Group 1 Observation GroupExperimentalStandard of care treatment (at least 2nd generation Type 1 antihistamines [H1AH] with or without other permitted background medications) for 52 weeks. For participants with worsening disease (UAS7 score of 16 or greater at any time between Weeks 0-24), barzolvolimab will be administered once as a 300 mg subcutaneous injection followed by 150 mg every 4 weeks for up to 52 weeks.
Receives: Biological: barzolvolimab; Other: Standard of Care
Group 2 Barzolvolimab Retreatment GroupExperimentalBarzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Receives: Biological: barzolvolimab

What is being measured

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

  1. Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.

    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 (baseline) to Week 52.

  2. Time to disease worsening or treatment failure through Week 52 based on the occurrence of the discontinuation of barzolvolimab in Group 2 due to lack of efficacy or to a treatment related adverse event.

    Evaluate duration of efficacy of barzolvolimab on urticaria activity or to a treatment related adverse event.

    Measured: From Day 1 (baseline) to Week 52.

  3. Time to disease worsening or treatment failure through Week 52 based on the occurrence of first use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1.

    Evaluate duration of efficacy of barzolvolimab on urticaria activity leading to initiation of either a confounding prohibited medication (Group 1 or 2) or barzolvolimab in Group 1.

    Measured: From Day 1 (baseline) to Week 52.

Secondary outcomes (29)

  1. Group 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 26.

    Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).

    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 (baseline) in phase 3 trial to Week 26.

  2. Group 1: Change from baseline in UAS7 at Week 52/End of Study.

    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 (baseline) in phase 3 trial to Week 52/End of Study.

  3. Percentage of Group 1 participants with UAS7 ≤ 6 at week 26.

    Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 26.

    Measured: From Day 1 (baseline) to Week 26.

  4. Percentage of Group 1 participants with UAS7 ≤ 6 at week 52.

    Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 52.

    Measured: From Day 1 (baseline) to Week 52/End of Study.

  5. Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 26.

    Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0) at Day 1 who have well controlled CSU (UAS7 ≤ 6) at Week 26.

    Measured: From Day 1 (baseline) to Week 26.

  6. Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 52.

    Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0) at Day 1 who have well-controlled disease (UAS7 ≤ 6) at Week 52.

    Measured: From Day 1 (baseline) to Week 52/End of Treatment.

  7. Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 26.

    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 (baseline) to Week 26.

  8. Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 52.

    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 (baseline) to Week 52/End of Study.

  9. Group 1: Participants with UAS7 ≤ 6 at Day 1, time to loss of well-controlled disease through Week 52.

    Group 1: Participants with at least well-controlled disease (UAS7 ≤ 6) at Day 1, time to loss of well-controlled disease through Week 52.

    Measured: From Day 1 (baseline) to Week 52/End of Study.

  10. Group 1: Participants with UAS7 = 0 at Day 1, time to loss of complete controlled disease through Week 52.

    Group 1: Participants with complete absence of hives and itch (UAS7 = 0) at Day 1, time to loss of complete controlled disease through Week 52.

    Measured: From Day 1 (baseline) to Week 52/End of Study.

  11. Group 1: Participants with UAS7 = 0 and AAS7 = 0 at Day 1, time to loss of CSU completely controlled through Week 52.

    Group 1: Participants with complete controlled CSU (UAS7 = 0 and AAS7 = 0) at Day 1, time to loss of CSU completely controlled through Week 52.

    Measured: From Day 1 (baseline) to Week 52/End of Study.

  12. Group 2: Change from baseline in UAS7 at Week 12.

    Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).

    Measured: From Day 1 (baseline) to Week 12.

  13. Group 2: Change from baseline in UAS7 at Week 24.

    Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).

    Measured: From Day 1 (baseline) to Week 24.

  14. Group 2: Change from baseline in UAS7 at Week 52.

    Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).

    Measured: From Day 1 (baseline) to Week 52.

  15. Group 2: Change from baseline in UAS7 at Week 68.

    Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).

    Measured: From Day 1 (baseline) to Week 68.

  16. Group 2: Percentage of participants with UAS7 ≤ 6 at Week 12.

    Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 12.

    Measured: From Day 1 (baseline) to Week 12.

  17. Group 2: Percentage of participants with UAS7 ≤ 6 at Week 24.

    Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 24.

    Measured: From Day 1 (baseline) to Week 24.

  18. Group 2: Percentage of participants with UAS7 ≤ 6 at Week 52.

    Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 52.

    Measured: From Day 1 (baseline) to Week 52.

  19. Group 2: Percentage of participants with UAS7 ≤ 6 at Week 68.

    Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 68.

    Measured: From Day 1 (baseline) to Week 68.

  20. From Day 1 (baseline) to Week 68.

    Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.

    Measured: From Day 1 (baseline) to Week 12.

  21. Group 2: Percentage of participants with UAS7 = 0 at Week 24.

    Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24.

    Measured: From Day 1 (baseline) to Week 24.

  22. Group 2: Percentage of participants with UAS7 = 0 at Week 52.

    Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 52.

    Measured: From Day 1 (baseline) to Week 52.

  23. Group 2: Percentage of participants with UAS7 = 0 at Week 68.

    Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 68.

    Measured: From Day 1 (baseline) to Week 68.

  24. Group 1 Incidence of adverse events.

    Group 1: Proportion of participants experiencing adverse events during the study.

    Measured: From Day 1 to Week 52.

  25. Group 1 Incidence of non-treatment emergent adverse events.

    Group 1: Proportion of participants who never receive barzolvolimab retreatment experiencing non-treatment emergent adverse events.

    Measured: From Day 1 to Week 52.

  26. Group 1 Incidence of treatment emergent adverse events in participants receiving barzolvolimab retreatment.

    Group 1: Proportion of participants who receive barzolvolimab retreatment experiencing treatment emergent adverse events.

    Measured: From Day 1 to Week 68.

  27. Group 1 Incidence of treatment emergent adverse events leading to treatment discontinuation.

    Group 1: Proportion of participants who receive barzolvolimab retreatment experiencing treatment emergent adverse events leading to treatment discontinuation during the study.

    Measured: From Day 1 to Week 68.

  28. Group 2 Incidence of treatment emergent adverse events.

    Group 2: Proportion of participants experiencing treatment emergent adverse events during the study.

    Measured: Time Frame: From Day 1 to Week 68.

  29. Group 2 Incidence of treatment emergent adverse events leading to treatment discontinuation.

    Group 2: Proportion of participants experiencing treatment emergent adverse events leading to treatment discontinuation during the study.

    Measured: From Day 1 to 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 posted1 Dec 2025
  2. Study start25 Nov 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2028 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07256392
Sponsor's protocol ID
CDX0159-17
Status last verified
Oct 2026
First submitted
20 Nov 2025
Last updated
2 Nov 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 201 sites in 30 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Poland, Bulgaria, Canada, Argentina and 25 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?

Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater. (time frame: From Day 1 (baseline) to Week 52.). The study lists 3 primary outcomes in all. 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 NCT07256392.

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 2 Nov 2026.

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