A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
NCT ID: NCT05405660
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2022-06-28
2025-09-12
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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barzolvolimab 150 mg in patients with Symptomatic Dermographism
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
barzolvolimab
Subcutaneous Administration
barzolvolimab 300 mg in patients with Symptomatic Dermographism
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
barzolvolimab
Subcutaneous Administration
Placebo Comparator in patients with Symptomatic Dermographism
Placebo injection subcutaneous every 4 weeks for 20 weeks
Matching Placebo
Subcutaneous Administration
barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks
barzolvolimab
Subcutaneous Administration
barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks
barzolvolimab
Subcutaneous Administration
Placebo Comparator in patients with Chronic Inducible Cold Urticaria
Placebo injection subcutaneous every 4 weeks for 20 weeks
Matching Placebo
Subcutaneous Administration
Interventions
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barzolvolimab
Subcutaneous Administration
Matching Placebo
Subcutaneous Administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of chronic ColdU or SD \>/= 3 months.
3. Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
1. 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.
2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment and agree to stay on through trial.
3. UCT \< 12 during the 14 days prior to treatment.
4. Positive provocation test
1. for ColdU patients: developing a wheal at the test site within 10 min after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3)
2. for SD patients: developing a wheal at the test site within 10 min after using FricTest® with ≥ 3 pins at both screening (Visit 1) and randomization (Visit 3)
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
Exclusion Criteria
2. Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that 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 study procedures.
5. Known active HIV, hepatitis B or hepatitis C infection.
6. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such 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.
18 Years
ALL
No
Sponsors
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Celldex Therapeutics
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Allervie Clinical Research
Montgomery, Alabama, United States
One of a Kind Clinical Research Center, LLC
Paradise Valley, Arizona, United States
Little Rock Allergy & Asthma CRC
Little Rock, Arkansas, United States
Kern Research, Inc
Bakersfield, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Dawes Fretzin Dermatology Group, LLC
Indianapolis, Indiana, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, United States
Institute for Asthma and Allergy, PC/Department of Clinical Research
Chevy Chase, Maryland, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States
University of Cincinnati
Cincinnati, Ohio, United States
Allergy Partners of Kerrville
Kerrville, Texas, United States
Allergy Associates of Utah
Murray, Utah, United States
Outpatient Clinic for Individual Practice for Specialized Outpatient
Razgrad, , Bulgaria
Medical Center Iskar- EOOD Office of Clinical Allergology
Sofia, , Bulgaria
"Medical Center Ekselsior" OOD
Sofia, , Bulgaria
"University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical Allergology
Sofia, , Bulgaria
Medical Center "SYNEXUS SOFIA", EOOD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD
Stara Zagora, , Bulgaria
Vahlberg & Pild Clinic
Tallinn, , Estonia
East Tallin Central Hospital
Tallinn, , Estonia
High Technology Hospital Medcenter
Batumi, , Georgia
Healthy Future
Tbilisi, , Georgia
Center of Allergy and Immunology
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
Universitätsklinikum Augsburg
Augsburg, Bavaria, Germany
LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
München, Bavaria, Germany
Universitaetsklinikum Giessen u. Marburg GmbH
Marburg, Hesse, Germany
Elbe Klinikum Buxtehude
Buxtehude, Lower Saxony, Germany
Hannover Medical University
Hanover, Lower Saxony, Germany
Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
Oldenburg, Lower Saxony, Germany
Universitätsklinikum Düsseldorf - Dermatologie
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Dresden
Dresden, Saxony, Germany
Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen
Kiel, Schleswig-Holstein, Germany
Institute of Allergology IFA
Berlin, , Germany
Universitätsklinikum Heidelberg - Dermatologie
Heidelberg, , Germany
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
Budapest, , Hungary
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
Budapest, , Hungary
Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika
Debrecen, , Hungary
Allergo-Derm Bakos Kft
Szolnok, , Hungary
Óbudai Egészségügyi Centrum
Zalaegerszeg, , Hungary
Balvi and Gulbene Hospital Union
Balvi, , Latvia
Pauls Stradins Clinical University Hospital
Riga, , Latvia
"LOR" Clinic
Riga, , Latvia
Children Clinical University Hospital
Riga, , Latvia
Consilium Medicum
Riga, , Latvia
JSC Ausros Medicinos Centras
Kaunas, , Lithuania
JSC Inlita
Vilnius, , Lithuania
Center of Allergy Diagnosis and Treatment
Vilnius, , Lithuania
Centrum Medyczne PLEJADY
Krakow, , Poland
Malopolskie Centrum Alergologii
Krakow, , Poland
Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
Lodz, , Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej
Lublin, , Poland
Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
Opole, , Poland
Medicome Sp. z o.o.
Oświęcim, , Poland
Medicover Integrated Clinical Services Sp. zo.o.
Torun, , Poland
Klinika Ambroziak sp. z o.o.
Warsaw, , Poland
Iatros International
Bloemfontein, Free State, South Africa
WorthWhile Clinical Trials
Benoni, Gauteng, South Africa
Newtown Clinical Research
Johannesburg, Gauteng, South Africa
Ubuntu Clinical Research
Lenasia, Gauteng, South Africa
FCRN Clinical Trial Centre Vaal Triangle
Vereeniging, Gauteng, South Africa
Synapta Clinical Research
Durban, KwaZulu-Natal, South Africa
Dr PJ Sebastian
Durban, KwaZulu-Natal, South Africa
The University of Cape Town - Lung Institute
Cape Town, Mowbray, South Africa
HGU de Alicante
Alicante, , Spain
Hospital Bellvitge
Barcelona, , Spain
Hospital Vall d´ Hebron
Barcelona, , Spain
Universidad de Navarra
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Countries
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Other Identifiers
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2021-006447-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDX0159-07
Identifier Type: -
Identifier Source: org_study_id