Clinical trial NCT05405660: A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
Official title: : A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients With Chronic Inducible Urticaria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Inducible Urticaria
Keywords: CDX-0159
barzolvolimab
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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.

Key exclusion criteria:

1. Women who are pregnant or nursing.
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.

Primary outcomes:
measure: Percentage of patients with a negative provocation test at week 12
timeFrame: From baseline to week 12
Secondary outcomes:
measure: Change in provocation threshold and itch for ColdU
timeFrame: From baseline to week 12
measure: Change in provocation threshold for SD
timeFrame: From baseline to week 12
measure: Change in worst itch reported after provocation for ColdU
timeFrame: From baseline to week 12
measure: Combined patients with a negative provocation test at week 12
timeFrame: From baseline to week 12
measure: Change in worst itch reported after provocation for SD
timeFrame: From baseline to week 12
measure: Change in worst itch reported after provocation in both SD and ColdU
timeFrame: From baseline to week 12
measure: Percentage of patients experiencing adverse events
timeFrame: From baseline to week 20
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Montgomery
country: United States
facility: Allervie Clinical Research
state: Alabama
city: Paradise Valley
country: United States
facility: One of a Kind Clinical Research Center, LLC
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma CRC
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research, Inc
state: California
city: Redwood City
country: United States
facility: Allergy & Asthma Consultants
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Sarasota
country: United States
facility: Sarasota Clinical Research
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group, LLC
state: Indiana
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, PSC
state: Kentucky
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy, PC/Department of Clinical Research
state: Maryland
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Kerrville
country: United States
facility: Allergy Partners of Kerrville
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: Razgrad
country: Bulgaria
facility: Outpatient Clinic for Individual Practice for Specialized Outpatient
city: Sofia
country: Bulgaria
facility: Medical Center Iskar- EOOD Office of Clinical Allergology
city: Sofia
country: Bulgaria
facility: "Medical Center Ekselsior" OOD
city: Sofia
country: Bulgaria
facility: "University Multiprofile Hospital for Active Treatment 'Aleksandrovska" EAD, Clinic of Clinical Allergology
city: Sofia
country: Bulgaria
facility: Medical Center "SYNEXUS SOFIA", EOOD
city: Stara Zagora
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" AD
city: Tallinn
country: Estonia
facility: Vahlberg & Pild Clinic
city: Tallinn
country: Estonia
facility: East Tallin Central Hospital
city: Batumi
country: Georgia
facility: High Technology Hospital Medcenter
city: Tbilisi
country: Georgia
facility: Healthy Future
city: Tbilisi
country: Georgia
facility: Center of Allergy and Immunology
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic Consilium Medulla
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
state: Bayern
city: München
country: Germany
facility: LMU Klinikum - Klinik und Poliklinik für Dermatologie und Allergologie DASZ-Dermato-Allergologisches Studien Zentrum
state: Bayern
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen u. Marburg GmbH
state: Hessen
city: Buxtehude
country: Germany
facility: Elbe Klinikum Buxtehude
state: Niedersachsen
city: Hannover
country: Germany
facility: Hannover Medical University
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf - Dermatologie
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen Klinikum f. Dermatologie, Venerologie u. Allergologie Hufelandstr
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Institute of Allergology IFA
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg - Dermatologie
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
city: Zalaegerszeg
country: Hungary
facility: Óbudai Egészségügyi Centrum
city: Balvi
country: Latvia
facility: Balvi and Gulbene Hospital Union
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: "LOR" Clinic
city: Riga
country: Latvia
facility: Children Clinical University Hospital
city: Riga
country: Latvia
facility: Consilium Medicum
city: Kaunas
country: Lithuania
facility: JSC Ausros Medicinos Centras
city: Vilnius
country: Lithuania
facility: JSC Inlita
city: Vilnius
country: Lithuania
facility: Center of Allergy Diagnosis and Treatment
city: Krakow
country: Poland
facility: Centrum Medyczne PLEJADY
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
city: Lublin
country: Poland
facility: Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej
city: Opole
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii
city: Oświęcim
country: Poland
facility: Medicome Sp. z o.o.
city: Torun
country: Poland
facility: Medicover Integrated Clinical Services Sp. zo.o.
city: Warsaw
country: Poland
facility: Klinika Ambroziak sp. z o.o.
city: Bloemfontein
country: South Africa
facility: Iatros International
state: Free State
city: Benoni
country: South Africa
facility: WorthWhile Clinical Trials
state: Gauteng
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
state: Gauteng
city: Lenasia
country: South Africa
facility: Ubuntu Clinical Research
state: Gauteng
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre Vaal Triangle
state: Gauteng
city: Durban
country: South Africa
facility: Synapta Clinical Research
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr PJ Sebastian
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: The University of Cape Town - Lung Institute
state: Mowbray
city: Alicante
country: Spain
facility: HGU de Alicante
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Barcelona
country: Spain
facility: Hospital Vall d´ Hebron
city: Madrid
country: Spain
facility: Universidad de Navarra
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
References: