A Study of CDX-0159 in Patients With Chronic Inducible Urticaria

Last updated: November 4, 2025
Sponsor: Celldex Therapeutics
Overall Status: Completed

Phase

2

Condition

Urticaria

Hives (Urticaria)

Treatment

barzolvolimab

Matching Placebo

Clinical Study ID

NCT05405660
CDX0159-07
2021-006447-95
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

Eligibility Criteria

Inclusion

Key inclusion criteria:

  1. Males and females, >/= 18 years of age.

  2. Diagnosis of chronic ColdU or SD >/= 3 months.

  3. Diagnosis of ColdU or SD despite the use of a stable regimen of second generationnon-sedating H1-antihistamine as defined by:

  4. Recurrent pruritic wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.

  5. Must be on a stable regimen of second generation non-sedating H1-antihistaminefor >/= 4 weeks prior to study treatment and agree to stay on through trial.

  6. UCT < 12 during the 14 days prior to treatment.

  7. Positive provocation test

  8. for ColdU patients: developing a wheal at the test site within 10 min afterusing TempTest® at any temperature at both screening (Visit 1) andrandomization (Visit 3)

  9. for SD patients: developing a wheal at the test site within 10 min after usingFricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3)

  10. Both males and females of child-bearing potential must agree to use highly effectivecontraceptives during the study and for 150 days after treatment.

  11. Willing and able to complete a daily symptom electronic diary and comply with studyvisits.

Exclusion

Key exclusion criteria:

  1. Women who are pregnant or nursing.

  2. Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SDthat may interfere with study assessments.

  3. Active, pruritic skin condition in addition to CIndU.

  4. Medical condition that would cause additional risk or interfere with studyprocedures.

  5. Known active HIV, hepatitis B or hepatitis C infection.

  6. Vaccination of a live vaccine within 2 months prior to study treatment (subjectsmust agree to avoid vaccination during the study). Inactivated vaccines are allowedsuch as seasonal influenza injection or COVID-19 vaccine.

  7. History of anaphylaxis

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: barzolvolimab
Phase: 2
Study Start date:
June 28, 2022
Estimated Completion Date:
September 12, 2025

Study Description

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Inducible Urticaria (Cold Urticaria [ColdU] or Symptomatic Dermographism [SD]) who remain symptomatic despite the use of H1-antihistamines.

There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.

Connect with a study center

  • Outpatient Clinic for Individual Practice for Specialized Outpatient

    Razgrad, 7200
    Bulgaria

    Site Not Available

  • Outpatient Clinic for Individual Practice for Specialized Outpatient

    Razgrad 727696, 7200
    Bulgaria

    Site Not Available

  • "Medical Center Ekselsior" OOD

    Sofia,
    Bulgaria

    Site Not Available

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

    Sofia,
    Bulgaria

    Site Not Available

  • Medical Center "SYNEXUS SOFIA", EOOD

    Sofia,
    Bulgaria

    Site Not Available

  • Medical Center Iskar- EOOD Office of Clinical Allergology

    Sofia, 1504
    Bulgaria

    Site Not Available

  • "Medical Center Ekselsior" OOD

    Sofia 727011,
    Bulgaria

    Site Not Available

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

    Sofia 727011,
    Bulgaria

    Site Not Available

  • Medical Center "SYNEXUS SOFIA", EOOD

    Sofia 727011,
    Bulgaria

    Site Not Available

  • Medical Center Iskar- EOOD Office of Clinical Allergology

    Sofia 727011, 1504
    Bulgaria

    Site Not Available

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

    Stara Zagora,
    Bulgaria

    Site Not Available

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

    Stara Zagora 726848,
    Bulgaria

    Site Not Available

  • East Tallin Central Hospital

    Tallinn, 11312
    Estonia

    Site Not Available

  • Vahlberg & Pild Clinic

    Tallinn, 10134
    Estonia

    Site Not Available

  • East Tallin Central Hospital

    Tallinn 588409, 11312
    Estonia

    Site Not Available

  • Vahlberg & Pild Clinic

    Tallinn 588409, 10134
    Estonia

    Site Not Available

  • High Technology Hospital Medcenter

    Batumi, 6000
    Georgia

    Site Not Available

  • High Technology Hospital Medcenter

    Batumi 615532, 6000
    Georgia

    Site Not Available

  • Center of Allergy and Immunology

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Healthy Future

    Tbilisi, 0119
    Georgia

    Site Not Available

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186
    Georgia

    Site Not Available

  • Center of Allergy and Immunology

    Tbilisi 611717, 0159
    Georgia

    Site Not Available

  • Healthy Future

    Tbilisi 611717, 0119
    Georgia

    Site Not Available

  • Multiprofile Clinic Consilium Medulla

    Tbilisi 611717, 0186
    Georgia

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg 2954172, Bavaria 2951839 86179
    Germany

    Site Not Available

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

    München 2867713, Bavaria 2951839 80337
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg

    Augsburg, Bayern 86179
    Germany

    Site Not Available

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

    München, Bayern 80337
    Germany

    Site Not Available

  • Universitaetsklinikum Giessen u. Marburg GmbH

    Marburg 2873759, Hesse 2905330 35043
    Germany

    Site Not Available

  • Universitaetsklinikum Giessen u. Marburg GmbH

    Marburg, Hessen 35043
    Germany

    Site Not Available

  • Elbe Klinikum Buxtehude

    Buxtehude 2940451, Lower Saxony 2862926 21614
    Germany

    Site Not Available

  • Hannover Medical University

    Hanover 2910831, Lower Saxony 2862926 30625
    Germany

    Site Not Available

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

    Oldenburg 2857458, Lower Saxony 2862926 26133
    Germany

    Site Not Available

  • Elbe Klinikum Buxtehude

    Buxtehude, Niedersachsen 21614
    Germany

    Site Not Available

  • Hannover Medical University

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

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

    Oldenburg, Niedersachsen 26133
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf - Dermatologie

    Düsseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

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

    Essen, Nordrhein-Westfalen 45122
    Germany

    Site Not Available

  • Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf - Dermatologie

    Düsseldorf 2934246, North Rhine-Westphalia 2861876 40225
    Germany

    Site Not Available

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

    Essen 2928810, North Rhine-Westphalia 2861876 45122
    Germany

    Site Not Available

  • Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie

    Münster 2867543, North Rhine-Westphalia 2861876 48149
    Germany

    Site Not Available

  • Universitätsklinikum Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitätsklinikum Dresden

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Site Not Available

  • Institute of Allergology IFA

    Berlin, 12203
    Germany

    Site Not Available

  • Institute of Allergology IFA

    Berlin 2950159, 12203
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg - Dermatologie

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg - Dermatologie

    Heidelberg 2907911, 69120
    Germany

    Site Not Available

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

    Budapest,
    Hungary

    Site Not Available

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

    Budapest 3054643, 1085
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika

    Debrecen, H-4032
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika

    Debrecen 721472, H-4032
    Hungary

    Site Not Available

  • Allergo-Derm Bakos Kft

    Szolnok, 5000
    Hungary

    Site Not Available

  • Allergo-Derm Bakos Kft

    Szolnok 715126, 5000
    Hungary

    Site Not Available

  • Óbudai Egészségügyi Centrum

    Zalaegerszeg, 8900
    Hungary

    Site Not Available

  • Óbudai Egészségügyi Centrum

    Zalaegerszeg 3042638, 8900
    Hungary

    Site Not Available

  • Balvi and Gulbene Hospital Union

    Balvi, LV-4501
    Latvia

    Site Not Available

  • Balvi and Gulbene Hospital Union

    Balvi 461163, LV-4501
    Latvia

    Site Not Available

  • "LOR" Clinic

    Riga, LV-1004
    Latvia

    Site Not Available

  • Children Clinical University Hospital

    Riga, LV-1004
    Latvia

    Site Not Available

  • Consilium Medicum

    Riga, LV-1010
    Latvia

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • "LOR" Clinic

    Riga 456172, LV-1004
    Latvia

    Site Not Available

  • Children Clinical University Hospital

    Riga 456172, LV-1004
    Latvia

    Site Not Available

  • Consilium Medicum

    Riga 456172, LV-1010
    Latvia

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga 456172, LV-1002
    Latvia

    Site Not Available

  • JSC Ausros Medicinos Centras

    Kaunas, 49387
    Lithuania

    Site Not Available

  • JSC Ausros Medicinos Centras

    Kaunas 598316, 49387
    Lithuania

    Site Not Available

  • Center of Allergy Diagnosis and Treatment

    Vilnius, LT-09109
    Lithuania

    Site Not Available

  • JSC Inlita

    Vilnius, 08406
    Lithuania

    Site Not Available

  • Center of Allergy Diagnosis and Treatment

    Vilnius 593116, LT-09109
    Lithuania

    Site Not Available

  • JSC Inlita

    Vilnius 593116, 08406
    Lithuania

    Site Not Available

  • Centrum Medyczne PLEJADY

    Krakow, 30-363
    Poland

    Site Not Available

  • Malopolskie Centrum Alergologii

    Krakow, 31-624
    Poland

    Site Not Available

  • Centrum Medyczne PLEJADY

    Krakow 3094802, 30-363
    Poland

    Site Not Available

  • Malopolskie Centrum Alergologii

    Krakow 3094802, 31-624
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

    Lodz, 90-153
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

    Lodz 3093133, 90-153
    Poland

    Site Not Available

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej

    Lublin, 20-573
    Poland

    Site Not Available

  • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej

    Lublin 765876, 20-573
    Poland

    Site Not Available

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

    Opole, 45-401
    Poland

    Site Not Available

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

    Opole 3090048, 45-401
    Poland

    Site Not Available

  • Medicome Sp. z o.o.

    Oświęcim, 32600
    Poland

    Site Not Available

  • Medicome Sp. z o.o.

    Oświęcim 3089658, 32600
    Poland

    Site Not Available

  • Medicover Integrated Clinical Services Sp. zo.o.

    Torun, 87-100
    Poland

    Site Not Available

  • Medicover Integrated Clinical Services Sp. zo.o.

    Torun 3083271, 87-100
    Poland

    Site Not Available

  • Klinika Ambroziak sp. z o.o.

    Warsaw, 02-953
    Poland

    Site Not Available

  • Klinika Ambroziak sp. z o.o.

    Warsaw 756135, 02-953
    Poland

    Site Not Available

  • Iatros International

    Bloemfontein, Free State 9324
    South Africa

    Site Not Available

  • Iatros International

    Bloemfontein 1018725, Free State 967573 9324
    South Africa

    Site Not Available

  • WorthWhile Clinical Trials

    Benoni, Gauteng 1500
    South Africa

    Site Not Available

  • Newtown Clinical Research

    Johannesburg, Gauteng 2113
    South Africa

    Site Not Available

  • Ubuntu Clinical Research

    Lenasia, Gauteng 1827
    South Africa

    Site Not Available

  • FCRN Clinical Trial Centre Vaal Triangle

    Vereeniging, Gauteng 1935
    South Africa

    Site Not Available

  • WorthWhile Clinical Trials

    Benoni 1020098, Gauteng 1085594 1500
    South Africa

    Site Not Available

  • Newtown Clinical Research

    Johannesburg 993800, Gauteng 1085594 2113
    South Africa

    Site Not Available

  • Ubuntu Clinical Research

    Lenasia 983199, Gauteng 1085594 1827
    South Africa

    Site Not Available

  • FCRN Clinical Trial Centre Vaal Triangle

    Vereeniging 944385, Gauteng 1085594 1935
    South Africa

    Site Not Available

  • Dr PJ Sebastian

    Durban, KwaZulu-Natal 4092
    South Africa

    Site Not Available

  • Synapta Clinical Research

    Durban, KwaZulu-Natal 4001
    South Africa

    Site Not Available

  • Dr PJ Sebastian

    Durban 1007311, KwaZulu-Natal 972062 4092
    South Africa

    Site Not Available

  • Synapta Clinical Research

    Durban 1007311, KwaZulu-Natal 972062 4001
    South Africa

    Site Not Available

  • The University of Cape Town - Lung Institute

    Cape Town, Mowbray 7700
    South Africa

    Site Not Available

  • The University of Cape Town - Lung Institute

    Cape Town 3369157, Mowbray 7700
    South Africa

    Site Not Available

  • HGU de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • HGU de Alicante

    Alicante 2521978, 03010
    Spain

    Site Not Available

  • Hospital Bellvitge

    Barcelona,
    Spain

    Site Not Available

  • Hospital Vall d´ Hebron

    Barcelona, 9035
    Spain

    Site Not Available

  • Hospital Bellvitge

    Barcelona 3128760, 8907
    Spain

    Site Not Available

  • Hospital Vall d´ Hebron

    Barcelona 3128760, 9035
    Spain

    Site Not Available

  • Universidad de Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Universidad de Navarra

    Madrid 3117735, 28027
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga, 29009
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga 2514256, 29009
    Spain

    Site Not Available

  • Hospital Arnau de Vilanova

    Valencia, 46015
    Spain

    Site Not Available

  • Hospital Arnau de Vilanova

    Valencia 2509954, 46015
    Spain

    Site Not Available

  • Clinical Research Center of Alabama

    Birmingham, Alabama 35249
    United States

    Site Not Available

  • Allervie Clinical Research

    Montgomery, Alabama 36106
    United States

    Site Not Available

  • Clinical Research Center of Alabama

    Birmingham 4049979, Alabama 4829764 35249
    United States

    Site Not Available

  • Allervie Clinical Research

    Montgomery 4076784, Alabama 4829764 36106
    United States

    Site Not Available

  • One of a Kind Clinical Research Center, LLC

    Paradise Valley, Arizona 85253
    United States

    Site Not Available

  • One of a Kind Clinical Research Center, LLC

    Paradise Valley 5308049, Arizona 5551752 85253
    United States

    Site Not Available

  • Little Rock Allergy & Asthma CRC

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Little Rock Allergy & Asthma CRC

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • Kern Research, Inc

    Bakersfield, California 93301
    United States

    Site Not Available

  • Allergy & Asthma Consultants

    Redwood City, California 94063
    United States

    Site Not Available

  • Kern Research, Inc

    Bakersfield 5325738, California 5332921 93301
    United States

    Site Not Available

  • Allergy & Asthma Consultants

    Redwood City 5386834, California 5332921 94063
    United States

    Site Not Available

  • IMMUNOe Research Centers

    Centennial, Colorado 80112
    United States

    Site Not Available

  • IMMUNOe Research Centers

    Centennial 5416541, Colorado 5417618 80112
    United States

    Site Not Available

  • Sarasota Clinical Research

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Sarasota Clinical Research

    Sarasota 4172131, Florida 4155751 34239
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise 5586437, Idaho 5596512 83706
    United States

    Site Not Available

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Dawes Fretzin Dermatology Group, LLC

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Site Not Available

  • Allergy & Asthma Specialists, PSC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Allergy & Asthma Specialists, PSC

    Owensboro 4303436, Kentucky 6254925 42301
    United States

    Site Not Available

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

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

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

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Allergy Partners of Kerrville

    Kerrville, Texas 78028
    United States

    Site Not Available

  • Allergy Partners of Kerrville

    Kerrville 4703078, Texas 4736286 78028
    United States

    Site Not Available

  • Allergy Associates of Utah

    Murray, Utah 84107
    United States

    Site Not Available

  • Allergy Associates of Utah

    Murray 5778755, Utah 5549030 84107
    United States

    Site Not Available

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