A Study of Barzolvolimab in Patients With Prurigo Nodularis
NCT ID: NCT06366750
Last Updated: 2025-12-18
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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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2024-04-12
2027-03-31
Brief Summary
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Detailed Description
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There is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. Participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo Q4W.
Following the completion of the treatment period, participants may enter an open label extension portion of the study if they are eligible.
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 450 mg, then 150 mg Q4W
450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.
barzolvolimab
subcutaneous administration
Barzolvolimab 450 mg, then 300 mg Q4W
450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.
barzolvolimab
subcutaneous administration
Placebo
Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.
Matching Placebo
subcutaneous administration
Interventions
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barzolvolimab
subcutaneous administration
Matching Placebo
subcutaneous administration
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
1. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
2. An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
3. Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
4. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
5. Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
7. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Exclusion Criteria
2. Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
3. Active unstable pruritic skin conditions in addition to PN.
4. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
5. Females who are pregnant or nursing.
6. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
7. Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
8. History of anaphylaxis.
9. Prior receipt of 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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Total Dermatology
Birmingham, Alabama, United States
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, United States
Investigate MD, LLC
Scottsdale, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States
Center for Dermatology Clinical Research, Inc
Fremont, California, United States
Profound Research LLC
Oceanside, California, United States
Empire Clinical Research
Pomona, California, United States
University of California San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Dermatology Institute & Skin Care Center
Santa Monica, California, United States
Focus Clinical Research
West Hills, California, United States
Encore Medical Research Boynton Beach
Boynton Beach, Florida, United States
Biobrilliance Medical Research Center
Hialeah, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Life Arc Research Centers Corp
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Advanced Clinical Research Institute
Tampa, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Emory University
Atlanta, Georgia, United States
Centricity Research
Columbus, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
MetroMed Clinical Trials
Chicago, Illinois, United States
DS Research of Southern Indiana, LLC
Clarksville, Indiana, United States
Equity Medical
Bowling Green, Kentucky, United States
DS Research of Kentucky, LLC
Louisville, Kentucky, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, United States
Revival Research Institute, LLC
Troy, Michigan, United States
Medisearch, LLC
Saint Joseph, Missouri, United States
Skin Specialists PC
Omaha, Nebraska, United States
University of New Mexico Department of Dermatology
Albuquerque, New Mexico, United States
Equity Medical
New York, New York, United States
Apex Clinical Research Center - Canton
Canton, Ohio, United States
UC Health Physicians Office Dermatology
Cincinnati, Ohio, United States
Paddington Testing, PO
Philadelphia, Pennsylvania, United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, United States
Columbia Dermatology and Aesthetics
Columbia, South Carolina, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
West Virginia Research Institute
Morgantown, West Virginia, United States
Stratica Dermatology
Edmonton, Alberta, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Kingsway Clinical Research
Etobicoke, Ontario, Canada
Guelph Dermatology Research
Guelph, Ontario, Canada
Derm Effects
London, Ontario, Canada
North York Research Inc
Toronto, Ontario, Canada
Special Hospital Medico
Rijeka, , Croatia
University Hospital Center - Rijeka
Rijeka, , Croatia
Solmed Clinic
Zagreb, , Croatia
Universitätsklinikum Augsburg
Augsburg, , Germany
Fachklinik Bad Bentheim, Klinisches Studienzentrum
Bad Bentheim, , Germany
Institut für Allergieforschung (IFA),Charité - Universitätsmedizin Berlin
Berlin, , Germany
Katholisches Klinikum Bochum
Bochum, , Germany
Universitätsklinikum Erlangen - Hautklinik
Erlangen, , Germany
Universitätsklinikum RWTH Aachen- Dermatology
Frankfurt, , Germany
Universtätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und
Frankfurt, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Universitätsklinikum Münster (UKM)
Münster, , Germany
Universitätsklinikum Tübingen - Hautklinik
Tübingen, , Germany
Centrum Nowoczesnych Terapii "Dobry Lekarz"
Krakow, Małopolska, Poland
FutureMeds Gdynia
Gdynia, , Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Gyncentrum sp. z o.o.
Katowice, , Poland
Pratia MCM Krakόw
Krakow, , Poland
LUXDERM Specjalistyczny Gabinet
Lublin, , Poland
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
Rzeszów, , Poland
Clinical /research group Z.o.o.
Warsaw, , Poland
Gyncentrum sp. z o.o., NZOZ Gyncentrum - Oddział Warszawa
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
DERMACEUM Centrum Badan
Wroclaw, , Poland
Complexo Hospitalario Universitario de Santiago de Compostela
A Coruña, , Spain
Hospital General Universitario Dr Balmis, ISABIAL
Alicante, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
FutureMeds - Madrid
Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid
Madrid, , Spain
FutureMeds - Sevilla
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Other Identifiers
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CDX0159-10
Identifier Type: -
Identifier Source: org_study_id
2023-510279-80-00
Identifier Type: OTHER
Identifier Source: secondary_id