Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for chronic hives: barzolvolimab shows promise in Long-Term trial

NCT ID NCT07256392

Disease control Sponsor: Celldex Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 6 times

Summary

This study looks at the long-term safety and effectiveness of barzolvolimab in adults with chronic spontaneous urticaria (CSU), a condition causing frequent hives and itching. Participants have already completed earlier phase 3 trials. The goal is to see how well the drug controls symptoms over time and to provide continued access to treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,370 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Written informed consent 2. Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13). 3. 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. 4. Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary. Key Exclusion Criteria: 1. Active pruritic skin condition in addition to CSU. 2. Medical condition that would cause additional risk or interfere with study procedures. 3. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic spontaneous urticaria are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic spontaneous urticaria

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    131 sites in 23 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • About Allergy

    Pretoria, Gauteng, 0181, South Africa

  • Advanced Clinical Research Institute (ACRI) - Florida

    Tampa, Florida, 33607, United States

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Alergo-med Ośrodek Badań Klinicznych Spólka z ograniczoną odpowiedzialnością

    Tarnów, 33-100, Poland

  • Alina Clinical Trials LLC

    Dallas, Texas, 75225, United States

  • Allergy Associates of Utah

    Sandy City, Utah, 84093, United States

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

    Laguna Niguel, California, 92677, United States

  • Allergy and Asthma Care of Waco

    Waco, Texas, 76712, United States

  • Allergy and Asthma Specialists PSC

    Owensboro, Kentucky, 42301, United States

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    CABA, Buenos Aires F.D., 1406, Argentina

  • Asthma and Allergy Associates

    Colorado Springs, Colorado, 80907, United States

  • Auni Allergy

    Findlay, Ohio, 45840, United States

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 20128, Italy

  • Bexley Dermatology Research

    Bexley, Ohio, 43209, United States

  • CD8 Klinika

    Kaunas, LT-44192, Lithuania

  • CHRU Nantes Hôtel Dieu

    Nantes, 44093, France

  • CHU de Nice-Hôpital L'Archet

    Nice, 06202, France

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham, Alabama, 35244, United States

  • Center for Dermatology & Plastic Surgery - Avacare

    Scottsdale, Arizona, 85260, United States

  • Centre de Recherche Saint-Louis

    Québec, G1W4R4, Canada

  • Centricity Research Columbus Dermatology

    Columbus, Georgia, 31904, United States

  • Centro Internacional de Estudios Clinicos (CIEC)

    Recoleta, 8420383, Chile

  • Centro Respiratorio Infantil

    Rosario, Sante Fe, 2000, Argentina

  • Centro de Estudios Clínicos e Investigaciones Médicas CeCim

    Santiago, 8350595, Chile

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

    Gdansk, 80-546, Poland

  • Centrum Medyczne ALL-MED Badania Kliniczne

    Krakow, 30-033, Poland

  • Centrum Medyczne Katowice - PRATIA

    Katowice, 40-081, Poland

  • Centrum Medyczne Pratia Częstochowa

    Częstochowa, 42-217, Poland

  • Centrum Medyczne Pratia Poznan

    Poznan, 60-185, Poland

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

    Krakow, 31-011, Poland

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

    Wroclaw, 50-566, Poland

  • Clinica Mayo de Urgencias

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Clinical Partners LLC

    Johnston, Rhode Island, 02919, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Conexa Investigación Clínica S.A.

    CABA, Buenos Aires F.D., 1012, Argentina

  • Cornerstone Dermatology

    Coorparoo, QSL, 4151, Australia

  • Deluxe Health Center

    Miami Lakes, Florida, 33014, United States

  • Dermacross Clinica Dermatologica

    Vitacura, 7630000, Chile

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Diagnostic Consultative Centre - Focus-5 - LZIP EOOD

    Sofia, 1463, Bulgaria

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431, Bulgaria

  • Direct Helpers Research Center

    Hialeah, Florida, 33012, United States

  • Dolphin Medical Research

    Doral, Florida, 33172, United States

  • ETG Warszawa Sp. z o.o.

    Warsaw, 02-677, Poland

  • Encore Medical Research of Boynton Beach LLC

    Boynton Beach, Florida, 33436, United States

  • Endeavor Health

    Skokie, Illinois, 60026, United States

  • Enroll SpA - Dr. Manuel Barros Borgono

    Providencia, 7500000, Chile

  • EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu

    Wroclaw, 54-144, Poland

  • Evidence Based Medical Educator Inc.

    Toronto, Ontario, M5G1E2, Canada

  • G.S.V.M. Medical College

    Nashik, Maharashtra, 422101, India

  • GCP, Global Clinical Professionals

    St. Petersburg, Florida, 33705, United States

  • Gentofte Hospital

    Hellerup, 2900, Denmark

  • Ginemedica Sp. z o.o.

    Wroclaw, 50-414, Poland

  • Global Clinical Trials (Pty) Ltd - Pretoria

    Pretoria, Gauteng, 0157, South Africa

  • Hanyang University Seoul Hospital

    Seoul, 4763, South Korea

  • Hospital A. Syggros

    Athens, 16121, Greece

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Clinico San Carlos - Lopez Bran

    Madrid, 28040, Spain

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010, Spain

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Umum Sarawak

    Kuching, 93586, Malaysia

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario de La Plana

    Villarreal de Huerva, 12540, Spain

  • Hospital del Mar

    Barcelona, 8003, Spain

  • Institute for Asthma and Allergy

    Wheaton, Maryland, 20902, United States

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Sante Fe, S2000DEJ, Argentina

  • Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

    Rosario, Sante Fe, 2000, Argentina

  • Joel Liem Medicine Professional Corporation

    Windsor, Ontario, N8X 2G1, Canada

  • John Hopkins University

    Baltimore, Maryland, 21224, United States

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813414, Taiwan

  • Kern Research

    Bakersfield, California, 93301, United States

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953, Poland

  • LA Universal Research Center, Inc.

    Los Angeles, California, 90057, United States

  • Lima's Excellence In Allergy And Dermatology Research (Leader) Inc.

    Hamilton, Ontario, L8L 3C3, Canada

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Dorota Krasowska

    Lublin, 20-753, Poland

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3, Canada

  • MICS Centrum Medyczne Toruń

    Torun, 87-100, Poland

  • MacKay Memorial Hospital

    Taipei, 10449, Taiwan

  • Markowitz Medical PLLC dba OptiSkin Medical

    New York, New York, 10128, United States

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center Iskar EOOD

    Sofia, 1000, Bulgaria

  • Medical Center Medtech Services EOOD

    Haskovo, 6304, Bulgaria

  • Medical Center Pulmovision

    Sofia, 1756, Bulgaria

  • Medical Centre Asklepii OOD

    Dupnitsa, 2600, Bulgaria

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251, United States

  • Medicome Sp. z o.o.

    Oświęcim, 32-600, Poland

  • Medizinisches Versorgungszentrum DermaKiel GmbH

    Kiel, Schleswig-Holstein, 24148, Germany

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176, United States

  • Michigan Center for Research Co., LLC

    Clarkston, Michigan, 48346, United States

  • Midwest Clinical Research

    St Louis, Missouri, 63141, United States

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808, United States

  • NZOZ Specjalistyczny Ośrodek Dermatologiczny "DERMAL"

    Bialystok, 15-453, Poland

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • National Taiwan University Hospital - Hsin-Chu Branch

    Hsinchu, 300, Taiwan

  • Newtown Clinical Research Centre

    Newtown, Gauteng, 2001, South Africa

  • Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.

    Skarżysko-Kamienna, 26-110, Poland

  • North Bay Dermatology Center

    North Bay, Ontario, P1B 3Z7, Canada

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

    Razgrad, 7200, Bulgaria

  • Oyster & Pearl Hospitals

    Pune, Maharashtra, 411005, India

  • Portland Allergy and Asthma

    Clackamas, Oregon, 97015, United States

  • ProDerma

    Dülmen, North Rhine-Westphalia, 48249, Germany

  • Rainey & Finklea San Antonio (RFSA) Dermatology

    San Antonio, Texas, 78213, United States

  • Respiratory Medicine Research Institute of Michigan PLC

    Ypsilanti, Michigan, 48197, United States

  • Rosenpark Research

    Darmstadt, Hesse, 64283, Germany

  • Sarasota Clinical Research

    Sarasota, Florida, 34239, United States

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Shree Hospital & Critical Care Centre

    Nagpur, Maharashtra, 440009, India

  • Synapta Clinical Research Centre

    Durban, KwaZulu-Natal, 4001, South Africa

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

    Katowice, 40-040, Poland

  • Thammasat University Hospital

    Khlong Luang, 12120, Thailand

  • The Alfred Hospital - Kern

    Melbourne, Victoria, 3004, Australia

  • The Diagnostic-Consultative Centre Ascendent EOOD

    Sofia, 1202, Bulgaria

  • The South Bend Clinic - Avacare

    South Bend, Indiana, 46617, United States

  • Toledo Institute for Clinical Research

    Toledo, Ohio, 43617, United States

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617, United States

  • ULS da Arrábida, EPE - Hospital de São Bernardo

    Setúbal, 2910-548, Portugal

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

    Aveiro, 3814-501, Portugal

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

    Coimbra, 3004-561, Portugal

  • ULS de Santa Maria,EPE - Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    Chaïdári, Attica, 12462, Greece

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

    Sofia, 1606, Bulgaria

  • University of Cape Town Lung Institute (UCTLI)

    Mowbray, Western Cape, 7700, South Africa

  • VIDA Dermatology

    Edmonton, Alberta, T6H 4J8, Canada

  • Velocity Clinical Research, North London

    North Finchley, N12 8BU, United Kingdom

  • Washington University School of Medicine

    St Louis, Missouri, 63141, United States

  • Western Sky Medical Research

    El Paso, Texas, 79912, United States

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1501, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.