A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria
NCT ID: NCT05368285
Last Updated: 2025-03-26
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
208 participants
INTERVENTIONAL
2022-05-19
2024-12-20
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 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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barzolvolimab 75 mg then 150 mg
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks
barzolvolimab
Subcutaneous Administration
barzolvolimab 75 mg then 300 mg
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks
barzolvolimab
Subcutaneous Administration
barzolvolimab 150 mg
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks
barzolvolimab
Subcutaneous Administration
barzolvolimab 300 mg
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks
barzolvolimab
Subcutaneous Administration
Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks
barzolvolimab
Subcutaneous Administration
Matching Placebo
Subcutaneous Administration
Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks
barzolvolimab
Subcutaneous Administration
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 spontaneous urticaria (CSU) \>/= 6 months.
3. Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
1. The presence of hives 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.
3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to treatment.
4. Normal blood counts and liver function tests
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. Clearly defined cause for chronic urticaria.
3. Active, pruritic skin condition in addition to CSU.
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
8. Prior treatment with barzolvolimab
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 dba Allervie Clinical Research
Birmingham, Alabama, United States
Medical Research of Arizona
Scottsdale, 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
Treasure Valley Medical Research
Boise, Idaho, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States
Chesapeake Clinical Research
White Marsh, Maryland, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Montefiore Medical Center/Subspeciality-Allergy and Immunology
The Bronx, New York, United States
"Diagnostic Consultative Center Pulmed" EOOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, , Bulgaria
Outpatient clinic for individual practice for specialized outpatient medical care in allergology-Doctor Thalat Sally Cholak EOOD
Razgrad, , Bulgaria
Medical Center Iskar EOOD Office of Clinical Allergology
Sofia, , Bulgaria
Medical Center "SYNEXUS SOFIA", EOOD
Sofia, , Bulgaria
Vahlberg & Pild Clinic
Tallinn, , Estonia
Healthy Future
Tbilisi, , Georgia
Center of Allergy and Immunology
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
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
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 Münster Klinik u. Poliklinik f. Dermatologie
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Dresden
Dresden, Saxony, Germany
Universitätsklinikum Schleswig-Holstein - Zentrum für entzündliche Hauterkrankunge
Kiel, Schleswig-Holstein, Germany
Charite - Institute of Allergology IFA Campus Benjamin Franklin
Berlin, , Germany
Universitätsklinikum Heidelberg - Dermatologie
Heidelberg, , Germany
Semmelweis Egyetem, ÁOK, Bőr-, Nemikórtani és Bőronkológiai Klinika
Budapest, , Hungary
Debreceni Egyetem, ÁOK és KK, Bőrgyógyászati Tanszék és Bőrgyógyászati Klinika
Debrecen, , Hungary
Allergo-Derm Bakos Kft. Bőrgyógyászati Magánrendelő
Szolnok, , Hungary
Óbudai Egészségügyi Centrum Kft.
Zalaegerszeg, , Hungary
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 Krasowskie
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. Z.o.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, , South Africa
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Bellvitge
Barcelona, , Spain
Universidad de Navarra
Madrid, , Spain
Countries
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Other Identifiers
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2021-006413-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDX0159-06
Identifier Type: -
Identifier Source: org_study_id
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