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New shot may stop hives from cold and scratching

NCT ID NCT07266402

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 study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 6 times

Summary

This study tests an investigational drug called barzolvolimab in 240 adults who get hives from cold temperatures or from scratching their skin, and whose symptoms are not controlled by standard allergy pills. Participants receive either the drug or a placebo injection, and doctors check if hives disappear after a cold or friction test at 12 and 24 weeks. The goal is to see if the drug can better control these chronic skin reactions.

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 240 people

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

Started

Jan 2026

Expected to finish

Oct 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. Males and females, \>/= 18 years of age. 2. Diagnosis of cold induced urticaria or symptomatic dermographism \>/= 3 months. 3. Diagnosis of cold induced urticaria or symptomatic dermographism 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 H1-antihistamines. 2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment. 3. Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and \< 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening 5. Normal blood counts and liver function tests. 6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment. 7. Willing and able to complete a daily symptom electronic diary and comply with study visits. 8. Participants with and without prior biologic experience are eligible. Key Exclusion Criteria: 1. Women who are pregnant or nursing. 2. Clearly defined cause for chronic urticaria. 3. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism. 4. Medical condition that would cause additional risk or interfere with study procedures. 5. Known HIV, hepatitis B or hepatitis C infection. 6. Vaccination with a live vaccine within 30 days prior to screening (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine. 7. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water). 8. Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

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Conditions

The condition(s) this trial relates to.

chronic inducible urticaria cold urticaria familial dermatographia

As listed by the trial registrant

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

Chronic inducible urticaria Cold urticaria Cold-induced urticaria Symptomatic dermographism

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    72 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Addenbrooke's Hospital

    NOT_YET_RECRUITING

    Cambridge, United Kingdom

  • Advanced Clinical Research Institute

    RECRUITING

    Tampa, Florida, 33607, United States

  • Advanced Dermatology and Cosmetic Surgery - Spartanburg

    RECRUITING

    Spartanburg, South Carolina, 29307, United States

  • Advanced ENT and Allergy, PLLC

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Alergo-med Ośrodek Badań Klinicznych Sp. z o. o.

    RECRUITING

    Tarnów, Poland

  • Allergy & Asthma Consultants

    RECRUITING

    Redwood City, California, 94063, United States

  • Allergy & Immunology Unit, University of Cape Town Lung Institute

    RECRUITING

    Cape Town, South Africa

  • Allergy Associates of Utah

    RECRUITING

    Sandy City, Utah, 84093, United States

  • Allergy and Asthma Centre

    RECRUITING

    Westville, South Africa

  • Allergy, Asthma & Clinical Research Center

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Amicis Research Center

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • CD8 Klinika

    RECRUITING

    Kaunas, Lithuania

  • Cahaba Dermatology & Skin Health Center, LLC

    RECRUITING

    Birmingham, Alabama, 35244, United States

  • Centricity Research Columbus Dermatology

    RECRUITING

    Columbus, Georgia, 31904, United States

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

    RECRUITING

    Gdansk, 80-546, Poland

  • Centrum Medyczne ALL-MED Badania Kliniczne

    RECRUITING

    Krakow, Poland

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

    RECRUITING

    Krakow, Poland

  • Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

    RECRUITING

    Wroclaw, Poland

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Spain

  • Deluxe Health Center, LLC

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Department of Dermatology, University Hospital Dusseldorf

    RECRUITING

    Düsseldorf, Germany

  • Direct Helpers Research Center

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Dr. PJ Sebastian

    RECRUITING

    Durban, South Africa

  • Elbe Kliniken Buxtehude Dermatologie

    RECRUITING

    Buxtehude, Germany

  • Endeavor Health Clinical Trials Center

    RECRUITING

    Skokie, Illinois, 60077, United States

  • Equity Medical, LLC

    RECRUITING

    Bowling Green, Kentucky, 42104, United States

  • Equity Medical, LLC

    RECRUITING

    New York, New York, 10023, United States

  • FOMAT - Allergy, Asthma & Immunology Medical Group

    RECRUITING

    Ventura, California, 93003, United States

  • Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP Immunologie und Allergologie IA c/o Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, Germany

  • GCP, Global Clinical Professionals

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Global Clinical Trials (Pty) Ltd

    RECRUITING

    Pretoria, South Africa

  • Hautklinik, Uniklinkum Erlangen

    RECRUITING

    Erlangen, Germany

  • Hospital del Mar

    RECRUITING

    Barcelona, Spain

  • Infinity Dermatology Inc

    RECRUITING

    Durban, South Africa

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Kern Research, Inc.

    RECRUITING

    Bakersfield, California, 93301, United States

  • Klinik und Poliklinik für Dermatologie und Allergologie, LMU Klinikum; DASZ-Dermato-Allergologisches Studienzentrum

    RECRUITING

    München, Germany

  • Klinika Ambroziak Dermatologia

    RECRUITING

    Warsaw, Poland

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska

    RECRUITING

    Lublin, Poland

  • MICS Centrum Medyczne Toruń

    RECRUITING

    Torun, Poland

  • MVZ DermaKiel GmbH

    RECRUITING

    Kiel, Germany

  • Markowitz Medical PLLC dba OptiSkin Medical

    RECRUITING

    New York, New York, 10128, United States

  • Medicome Sp. z o.o.

    RECRUITING

    Oświęcim, Poland

  • Newtown Clinical Research Centre

    RECRUITING

    Johannesburg, South Africa

  • Oddzial Kliniczny Chorob Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

    NOT_YET_RECRUITING

    Lodz, Poland

  • One of a Kind Clinical Research Center

    RECRUITING

    Napa, California, 94558, United States

  • One of a Kind Clinical Research Center, LLC

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Queen Elizabeth University Hospital

    NOT_YET_RECRUITING

    Glasgow, United Kingdom

  • RFSA Dermatology

    RECRUITING

    San Antonio, Texas, 78212, United States

  • Revival Research Institute, LLC

    RECRUITING

    Troy, Michigan, 48084, United States

  • Rosenpark Research GmbH

    RECRUITING

    Darmstadt, Germany

  • Salford Care Organisation NCA NHS Trust

    NOT_YET_RECRUITING

    Manchester, United Kingdom

  • Sandton Medical Research Centre

    RECRUITING

    Johannesburg, South Africa

  • Santa Familia PTG Lodz

    RECRUITING

    Lodz, Poland

  • Santaros KTC (klinikiniu tyrimu centras)

    RECRUITING

    Vilnius, Lithuania

  • Synapta Clinical Research Centre

    RECRUITING

    Durban, South Africa

  • Synexus Polska Sp. z o.o. Oddział w Gdańsku

    RECRUITING

    Gdansk, 80-382, Poland

  • Treasure Valley Medical Research

    RECRUITING

    Boise, Idaho, 83706, United States

  • UAB Alerginių susirgimų diagnostikos ir gydymo centras

    RECRUITING

    Vilnius, Lithuania

  • UAB Ausros Medicinos Centras

    RECRUITING

    Kaunas, Lithuania

  • University of Cincinnati

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45267, United States

  • Universitäts-Hautklinik Tübingen Studienzentrum Immundermatologie

    RECRUITING

    Tübingen, Germany

  • Universitätsklinikum Augsburg, Klinik für Dermatologie und Allergologie

    RECRUITING

    Augsburg, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Dermatologie

    RECRUITING

    Dresden, Germany

  • Universitätsklinikum Göttingen -- George-August-Universitat Göttinggen, Klinik für Dermatoogie, Venerologie und Allergologie

    RECRUITING

    Göttingen, Germany

  • Universitätsklinikum Heidelberg, Klinik für Dermatologie

    NOT_YET_RECRUITING

    Heidelberg, Germany

  • Universitätsklinikum Münster, Klinik u. Poliklinik f. Dermatologie

    RECRUITING

    Münster, Germany

  • Universitätsklinikum Schleswig-Holstein Universität zu Lübeck - Campus Lübeck

    RECRUITING

    Lübeck, Germany

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie; Klinika Dermatologii i Dermatologii Onkologicznej

    RECRUITING

    Rzeszów, Poland

  • Uniwersytecki Szpital Kliniczny w Opolu

    RECRUITING

    Opole, Poland

  • Well Pharma Medical Research, Corp.

    RECRUITING

    Miami, Florida, 33143, United States

  • Worthwhile Clinical Trials

    RECRUITING

    Benoni, South Africa

More trials for these conditions

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