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New shot could tame stubborn hives that antihistamines Can't stop

NCT ID NCT05405660

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 study tested a drug called barzolvolimab (CDX-0159) in 196 adults with chronic inducible urticaria—hives triggered by cold or scratching—that persist despite antihistamines. Participants received either the drug or a placebo as a shot under the skin. The main goal was to see if the drug could prevent hives from forming during a provocation test after 12 weeks. The trial is complete, and results may show whether this biologic offers a new option for people with hard-to-control hives.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
barzolvolimab (CDX-0159), a biologic drug given as a shot under the skin
What this could lead to
If it works, this could point toward a new treatment for people with chronic inducible urticaria who still have symptoms despite antihistamines.
What could go wrong
This is a Phase 2 trial, so it is still early. The drug may not prove effective or safe enough for larger studies or approval. Side effects are possible.

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

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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

Contacts and locations

Locations

  • "LOR" Clinic

    Riga, LV-1004, Latvia

  • "Medical Center Ekselsior" OOD

    Sofia, Bulgaria

  • "University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical Allergology

    Sofia, Bulgaria

  • Allergo-Derm Bakos Kft

    Szolnok, 5000, Hungary

  • Allergy & Asthma Consultants

    Redwood City, California, 94063, United States

  • Allergy & Asthma Specialists, PSC

    Owensboro, Kentucky, 42301, United States

  • Allergy Associates of Utah

    Murray, Utah, 84107, United States

  • Allergy Partners of Kerrville

    Kerrville, Texas, 78028, United States

  • Allervie Clinical Research

    Montgomery, Alabama, 36106, United States

  • Balvi and Gulbene Hospital Union

    Balvi, LV-4501, Latvia

  • Center of Allergy Diagnosis and Treatment

    Vilnius, LT-09109, Lithuania

  • Center of Allergy and Immunology

    Tbilisi, 0159, Georgia

  • Centrum Medyczne PLEJADY

    Krakow, 30-363, Poland

  • Children Clinical University Hospital

    Riga, LV-1004, Latvia

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35249, United States

  • Consilium Medicum

    Riga, LV-1010, Latvia

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika

    Debrecen, H-4032, Hungary

  • Dr PJ Sebastian

    Durban, KwaZulu-Natal, 4092, South Africa

  • East Tallin Central Hospital

    Tallinn, 11312, Estonia

  • Elbe Klinikum Buxtehude

    Buxtehude, Lower Saxony, 21614, Germany

  • FCRN Clinical Trial Centre Vaal Triangle

    Vereeniging, Gauteng, 1935, South Africa

  • HGU de Alicante

    Alicante, 03010, Spain

  • Hannover Medical University

    Hanover, Lower Saxony, 30625, Germany

  • Healthy Future

    Tbilisi, 0119, Georgia

  • High Technology Hospital Medcenter

    Batumi, 6000, Georgia

  • Hospital Arnau de Vilanova

    Valencia, 46015, Spain

  • Hospital Bellvitge

    Barcelona, 8907, Spain

  • Hospital Regional Universitario de Málaga

    Málaga, 29009, Spain

  • Hospital Vall d´ Hebron

    Barcelona, 9035, Spain

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112, United States

  • Iatros International

    Bloemfontein, Free State, 9324, South Africa

  • Institute for Asthma and Allergy, PC/Department of Clinical Research

    Chevy Chase, Maryland, 20815, United States

  • Institute of Allergology IFA

    Berlin, 12203, Germany

  • JSC Ausros Medicinos Centras

    Kaunas, 49387, Lithuania

  • JSC Inlita

    Vilnius, 08406, Lithuania

  • Kern Research, Inc

    Bakersfield, California, 93301, United States

  • Klinika Ambroziak sp. z o.o.

    Warsaw, 02-953, Poland

  • Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie

    Oldenburg, Lower Saxony, 26133, Germany

  • LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum

    München, Bavaria, 80337, Germany

  • Little Rock Allergy & Asthma CRC

    Little Rock, Arkansas, 72205, United States

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej

    Lublin, 20-573, Poland

  • Malopolskie Centrum Alergologii

    Krakow, 31-624, Poland

  • Medical Center "SYNEXUS SOFIA", EOOD

    Sofia, Bulgaria

  • Medical Center Iskar- EOOD Office of Clinical Allergology

    Sofia, 1504, Bulgaria

  • Medicome Sp. z o.o.

    Oświęcim, 32600, Poland

  • Medicover Integrated Clinical Services Sp. zo.o.

    Torun, 87-100, Poland

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186, Georgia

  • Newtown Clinical Research

    Johannesburg, Gauteng, 2113, South Africa

  • One of a Kind Clinical Research Center, LLC

    Paradise Valley, Arizona, 85253, United States

  • Outpatient Clinic for Individual Practice for Specialized Outpatient

    Razgrad, 7200, Bulgaria

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002, Latvia

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan, 48197, United States

  • Sarasota Clinical Research

    Sarasota, Florida, 34239, United States

  • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika

    Budapest, 1085, Hungary

  • Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika

    Budapest, Hungary

  • Synapta Clinical Research

    Durban, KwaZulu-Natal, 4001, South Africa

  • The University of Cape Town - Lung Institute

    Cape Town, Mowbray, 7700, South Africa

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Ubuntu Clinical Research

    Lenasia, Gauteng, 1827, South Africa

  • Universidad de Navarra

    Madrid, 28027, Spain

  • Universitaetsklinikum Giessen u. Marburg GmbH

    Marburg, Hesse, 35043, Germany

  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD

    Stara Zagora, Bulgaria

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • Universitätsklinikum Augsburg

    Augsburg, Bavaria, 86179, Germany

  • Universitätsklinikum Dresden

    Dresden, Saxony, 01307, Germany

  • Universitätsklinikum Düsseldorf - Dermatologie

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr

    Essen, North Rhine-Westphalia, 45122, Germany

  • Universitätsklinikum Heidelberg - Dermatologie

    Heidelberg, 69120, Germany

  • Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen

    Kiel, Schleswig-Holstein, 24105, Germany

  • Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

    Lodz, 90-153, Poland

  • Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii

    Opole, 45-401, Poland

  • Vahlberg & Pild Clinic

    Tallinn, 10134, Estonia

  • WorthWhile Clinical Trials

    Benoni, Gauteng, 1500, South Africa

  • Óbudai Egészségügyi Centrum

    Zalaegerszeg, 8900, Hungary

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