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

NCT05405660 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: CDX0159-072021-006447-95
• Study Type: interventional
• Target: 196
• Locations: 10 countries
• Sites: 74

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.

Conditions

Chronic Inducible Urticaria

Keywords

CDX-0159; barzolvolimab

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a negative provocation test at 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®

  From baseline to week 12

Secondary Outcomes (7)

• Change in provocation threshold and itch for ColdU

  From baseline to week 12

• Change in provocation threshold for SD

  From baseline to week 12

• Change in worst itch reported after provocation for ColdU

  From baseline to week 12

• Combined patients with a negative provocation test at week 12

  From baseline to week 12

• Change in worst itch reported after provocation for SD

  From baseline to week 12

Study Arms (6)

barzolvolimab 150 mg in patients with Symptomatic Dermographism

EXPERIMENTAL

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

Biological: barzolvolimab

barzolvolimab 300 mg in patients with Symptomatic Dermographism

EXPERIMENTAL

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Biological: barzolvolimab

Placebo Comparator in patients with Symptomatic Dermographism

PLACEBO COMPARATOR

Placebo injection subcutaneous every 4 weeks for 20 weeks

Drug: Matching Placebo

barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria

EXPERIMENTAL

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks

Biological: barzolvolimab

barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria

EXPERIMENTAL

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks

Biological: barzolvolimab

Placebo Comparator in patients with Chronic Inducible Cold Urticaria

PLACEBO COMPARATOR

Placebo injection subcutaneous every 4 weeks for 20 weeks

Drug: Matching Placebo

Interventions

barzolvolimab BIOLOGICAL

Subcutaneous Administration

Also known as: CDX-0159

barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria; barzolvolimab 150 mg in patients with Symptomatic Dermographism; barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria; barzolvolimab 300 mg in patients with Symptomatic Dermographism

Matching Placebo DRUG

Subcutaneous Administration

Placebo Comparator in patients with Chronic Inducible Cold Urticaria; Placebo Comparator in patients with Symptomatic Dermographism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, \>/= 18 years of age.
• Diagnosis of chronic ColdU or SD \>/= 3 months.
• Diagnosis of ColdU or SD despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
• 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.
• 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.
• UCT \< 12 during the 14 days prior to treatment.
• Positive provocation test
• 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)
• 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)
• Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
• Willing and able to complete a daily symptom electronic diary and comply with study visits.

You may not qualify if:

• Women who are pregnant or nursing.
• Active Chronic spontaneous urticaria or other forms of CIndU besides ColdU or SD that may interfere with study assessments.
• Active, pruritic skin condition in addition to CIndU.
• Medical condition that would cause additional risk or interfere with study procedures.
• Known active HIV, hepatitis B or hepatitis C infection.
• 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.
• History of anaphylaxis
• There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (76)

Clinical Research Center of Alabama

Birmingham, Alabama, 35249, United States

Location

Allervie Clinical Research

Montgomery, Alabama, 36106, United States

Location

One of a Kind Clinical Research Center, LLC

Paradise Valley, Arizona, 85253, United States

Location

Little Rock Allergy & Asthma CRC

Little Rock, Arkansas, 72205, United States

Location

Kern Research, Inc

Bakersfield, California, 93301, United States

Location

Allergy & Asthma Consultants

Redwood City, California, 94063, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Sarasota Clinical Research

Sarasota, Florida, 34239, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Dawes Fretzin Dermatology Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Allergy & Asthma Specialists, PSC

Owensboro, Kentucky, 42301, United States

Location

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

Chevy Chase, Maryland, 20815, United States

Location

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, 48197, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Allergy Partners of Kerrville

Kerrville, Texas, 78028, United States

Location

Allergy Associates of Utah

Murray, Utah, 84107, United States

Location

Outpatient Clinic for Individual Practice for Specialized Outpatient

Razgrad, 7200, Bulgaria

Location

Medical Center Iskar- EOOD Office of Clinical Allergology

Sofia, 1504, Bulgaria

Location

"Medical Center Ekselsior" OOD

Sofia, Bulgaria

Location

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

Sofia, Bulgaria

Location

Medical Center "SYNEXUS SOFIA", EOOD

Sofia, Bulgaria

Location

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

Stara Zagora, Bulgaria

Location

Vahlberg & Pild Clinic

Tallinn, 10134, Estonia

Location

East Tallin Central Hospital

Tallinn, 11312, Estonia

Location

High Technology Hospital Medcenter

Batumi, 6000, Georgia

Location

Healthy Future

Tbilisi, 0119, Georgia

Location

Center of Allergy and Immunology

Tbilisi, 0159, Georgia

Location

Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

Universitätsklinikum Augsburg

Augsburg, Bavaria, 86179, Germany

Location

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

München, Bavaria, 80337, Germany

Location

Universitaetsklinikum Giessen u. Marburg GmbH

Marburg, Hesse, 35043, Germany

Location

Elbe Klinikum Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

Location

Hannover Medical University

Hanover, Lower Saxony, 30625, Germany

Location

Klinikum Oldenburg gGmbH - Klinik f. Dermatologie u. Allergologie

Oldenburg, Lower Saxony, 26133, Germany

Location

Universitätsklinikum Düsseldorf - Dermatologie

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

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

Essen, North Rhine-Westphalia, 45122, Germany

Location

Universitätsklinikum Münster Klinik u. Poliklinik f. Dermatologie

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum Dresden

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankungen

Kiel, Schleswig-Holstein, 24105, Germany

Location

Institute of Allergology IFA

Berlin, 12203, Germany

Location

Universitätsklinikum Heidelberg - Dermatologie

Heidelberg, 69120, Germany

Location

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

Budapest, 1085, Hungary

Location

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

Budapest, Hungary

Location

Debreceni Egyetem Klinikai Központ (DEKK), Bőrgyógyászati Klinika

Debrecen, H-4032, Hungary

Location

Allergo-Derm Bakos Kft

Szolnok, 5000, Hungary

Location

Óbudai Egészségügyi Centrum

Zalaegerszeg, 8900, Hungary

Location

Balvi and Gulbene Hospital Union

Balvi, LV-4501, Latvia

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

"LOR" Clinic

Riga, LV-1004, Latvia

Location

Children Clinical University Hospital

Riga, LV-1004, Latvia

Location

Consilium Medicum

Riga, LV-1010, Latvia

Location

JSC Ausros Medicinos Centras

Kaunas, 49387, Lithuania

Location

JSC Inlita

Vilnius, 08406, Lithuania

Location

Center of Allergy Diagnosis and Treatment

Vilnius, LT-09109, Lithuania

Location

Centrum Medyczne PLEJADY

Krakow, 30-363, Poland

Location

Malopolskie Centrum Alergologii

Krakow, 31-624, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1 w Lodzi

Lodz, 90-153, Poland

Location

Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Doroty Krasowskiej

Lublin, 20-573, Poland

Location

Uniwersytecki Szpital Kliniczny w Opolu, Pododdział Chorób Wewnętrznych i Alergologii

Opole, 45-401, Poland

Location

Medicome Sp. z o.o.

Oświęcim, 32600, Poland

Location

Medicover Integrated Clinical Services Sp. zo.o.

Torun, 87-100, Poland

Location

Klinika Ambroziak sp. z o.o.

Warsaw, 02-953, Poland

Location

Iatros International

Bloemfontein, Free State, 9324, South Africa

Location

WorthWhile Clinical Trials

Benoni, Gauteng, 1500, South Africa

Location

Newtown Clinical Research

Johannesburg, Gauteng, 2113, South Africa

Location

Ubuntu Clinical Research

Lenasia, Gauteng, 1827, South Africa

Location

FCRN Clinical Trial Centre Vaal Triangle

Vereeniging, Gauteng, 1935, South Africa

Location

Synapta Clinical Research

Durban, KwaZulu-Natal, 4001, South Africa

Location

Dr PJ Sebastian

Durban, KwaZulu-Natal, 4092, South Africa

Location

The University of Cape Town - Lung Institute

Cape Town, Mowbray, 7700, South Africa

Location

HGU de Alicante

Alicante, 03010, Spain

Location

Hospital Bellvitge

Barcelona, 8907, Spain

Location

Hospital Vall d´ Hebron

Barcelona, 9035, Spain

Location

Universidad de Navarra

Madrid, 28027, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Chronic Inducible Urticaria

Condition Hierarchy (Ancestors)

Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: June 28, 2022
• Primary Completion: June 12, 2024
• Study Completion: September 12, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

PL (8); ES (6); GE (4); ZA (8); DE (13); BU (6); HU (5); LA (5); US (16); LI (3)