A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
- Conditions
- Chronic Inducible Urticaria
- Interventions
- Biological: barzolvolimabDrug: Matching Placebo
- Registration Number
- NCT05405660
- Lead Sponsor
- Celldex Therapeutics
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 196
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description barzolvolimab 150 mg in patients with Symptomatic Dermographism barzolvolimab barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks barzolvolimab 300 mg in patients with Symptomatic Dermographism barzolvolimab barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks Placebo Comparator in patients with Symptomatic Dermographism Matching Placebo Placebo injection subcutaneous every 4 weeks for 20 weeks barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria barzolvolimab barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria barzolvolimab barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks Placebo Comparator in patients with Chronic Inducible Cold Urticaria Matching Placebo Placebo injection subcutaneous every 4 weeks for 20 weeks
- Primary Outcome Measures
Name Time Method Percentage of patients with a negative provocation test at week 12 From baseline to week 12 Percentage of patients with a negative provocation test for Cold Inducible Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) at week 12
* For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®
* For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
- Secondary Outcome Measures
Name Time Method Change in worst itch reported after provocation in both SD and ColdU From baseline to week 12 Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD and ColdU combined
Change in provocation threshold for SD From baseline to week 12 Mean change from baseline to Week 12 in Critical Friction Threshold (CFT) in patients with SD
CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute markChange in worst itch reported after provocation for ColdU From baseline to week 12 Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with ColdU
Change in provocation threshold and itch for ColdU From baseline to week 12 Mean change from baseline to week 12 in critical temperature threshold (CTT) in patients with ColdU
CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute markCombined patients with a negative provocation test at week 12 From baseline to week 12 Percentage of combined patients with a negative TempTest (ColdU) or FricTest (SD) at week 12
Change in worst itch reported after provocation for SD From baseline to week 12 Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD
Percentage of patients experiencing adverse events From baseline to week 20 Percentage of patients experiencing treatment-emergent adverse events (TEAE) examined by ColdU patients, SD patients and in combination. A TEAE is any untoward medical occurrence in a patient administered a study treatment.
Trial Locations
- Locations (75)
Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
🇵🇱Lodz, Poland
Allergy & Asthma Specialists, PSC
🇺🇸Owensboro, Kentucky, United States
Synapta Clinical Research
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr PJ Sebastian
🇿🇦Durban, KwaZulu-Natal, South Africa
Children Clinical University Hospital
🇱🇻Riga, Latvia
JSC Ausros Medicinos Centras
🇱🇹Kaunas, Lithuania
Center of Allergy Diagnosis and Treatment
🇱🇹Vilnius, Lithuania
East Tallin Central Hospital
🇪🇪Tallinn, Estonia
JSC Inlita
🇱🇹Vilnius, Lithuania
Universidad de Navarra
🇪🇸Madrid, Spain
Respiratory Medicine Research Institute of Michigan, PLC
🇺🇸Ypsilanti, Michigan, United States
Allergy Associates of Utah
🇺🇸Murray, Utah, United States
Healthy Future
🇬🇪Tbilisi, Georgia
Kern Research, Inc
🇺🇸Bakersfield, California, United States
Allergy & Asthma Consultants
🇺🇸Redwood City, California, United States
Allervie Clinical Research
🇺🇸Montgomery, Alabama, United States
Universitätsklinikum Dresden
🇩🇪Dresden, Sachsen, Germany
Center of Allergy and Immunology
🇬🇪Tbilisi, Georgia
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Outpatient Clinic for Individual Practice for Specialized Outpatient
🇧🇬Razgrad, Bulgaria
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
High Technology Hospital Medcenter
🇬🇪Batumi, Georgia
Medicome Sp. z o.o.
🇵🇱Oświęcim, Poland
Medical Center "SYNEXUS SOFIA", EOOD
🇧🇬Sofia, Bulgaria
Institute for Asthma and Allergy, PC/Department of Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr
🇩🇪Essen, Nordrhein-Westfalen, Germany
Vahlberg & Pild Clinic
🇪🇪Tallinn, Estonia
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD
🇧🇬Stara Zagora, Bulgaria
Multiprofile Clinic Consilium Medulla
🇬🇪Tbilisi, Georgia
Balvi and Gulbene Hospital Union
🇱🇻Balvi, Latvia
LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
🇩🇪München, Bayern, Germany
Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitätsklinikum Düsseldorf - Dermatologie
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika
🇭🇺Debrecen, Hungary
Institute of Allergology IFA
🇩🇪Berlin, Germany
Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen
🇩🇪Kiel, Schleswig-Holstein, Germany
Iatros International
🇿🇦Bloemfontein, Free State, South Africa
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Elbe Klinikum Buxtehude
🇩🇪Buxtehude, Niedersachsen, Germany
Universitätsklinikum Heidelberg - Dermatologie
🇩🇪Heidelberg, Germany
"Medical Center Ekselsior" OOD
🇧🇬Sofia, Bulgaria
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
One of a Kind Clinical Research Center, LLC
🇺🇸Paradise Valley, Arizona, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
Little Rock Allergy & Asthma CRC
🇺🇸Little Rock, Arkansas, United States
Allergy Partners of Kerrville
🇺🇸Kerrville, Texas, United States
Dawes Fretzin Dermatology Group, LLC
🇺🇸Indianapolis, Indiana, United States
Medical Center Iskar- EOOD Office of Clinical Allergology
🇧🇬Sofia, Bulgaria
"University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical Allergology
🇧🇬Sofia, Bulgaria
Hannover Medical University
🇩🇪Hannover, Niedersachsen, Germany
Universitaetsklinikum Giessen u. Marburg GmbH
🇩🇪Marburg, Hessen, Germany
Universitätsklinikum Augsburg
🇩🇪Augsburg, Bayern, Germany
Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
🇩🇪Oldenburg, Niedersachsen, Germany
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
🇭🇺Budapest, Hungary
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Óbudai Egészségügyi Centrum
🇭🇺Zalaegerszeg, Hungary
Allergo-Derm Bakos Kft
🇭🇺Szolnok, Hungary
"LOR" Clinic
🇱🇻Riga, Latvia
Consilium Medicum
🇱🇻Riga, Latvia
Centrum Medyczne PLEJADY
🇵🇱Krakow, Poland
Malopolskie Centrum Alergologii
🇵🇱Krakow, Poland
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej
🇵🇱Lublin, Poland
Klinika Ambroziak sp. z o.o.
🇵🇱Warsaw, Poland
Medicover Integrated Clinical Services Sp. zo.o.
🇵🇱Torun, Poland
Newtown Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa
WorthWhile Clinical Trials
🇿🇦Benoni, Gauteng, South Africa
Ubuntu Clinical Research
🇿🇦Lenasia, Gauteng, South Africa
FCRN Clinical Trial Centre Vaal Triangle
🇿🇦Vereeniging, Gauteng, South Africa
HGU de Alicante
🇪🇸Alicante, Spain
The University of Cape Town - Lung Institute
🇿🇦Cape Town, Mowbray, South Africa
Hospital Bellvitge
🇪🇸Barcelona, Spain
Hospital Vall d´ Hebron
🇪🇸Barcelona, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain
Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
🇵🇱Opole, Poland