A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Patients With Prurigo Nodularis
Status: Recruiting
Location: See all (69) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Males and females, ≥18 years of age.
• Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
‣ At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
⁃ An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
• 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.
• Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
• Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
• 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.
• Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
Locations
United States
Alabama
Cahaba Dermatology Skin Health Center
RECRUITING
Birmingham
Total Dermatology
RECRUITING
Birmingham
Arkansas
Northwest Arkansas Clinical Trials Center
RECRUITING
Rogers
Arizona
Investigate MD, LLC
RECRUITING
Scottsdale
Scottsdale Clinical Trials
RECRUITING
Scottsdale
California
Center for Dermatology Clinical Research, Inc
RECRUITING
Fremont
Profound Research LLC
RECRUITING
Oceanside
Empire Clinical Research
RECRUITING
Pomona
Dermatology Institute & Skin Care Center
RECRUITING
Santa Monica
Focus Clinical Research
RECRUITING
West Hills
Florida
Biobrilliance Medical Research Center
RECRUITING
Hialeah
Life Arc Research Centers Corp
RECRUITING
Miami
University of Miami
RECRUITING
Miami
Advanced Clinical Research Institute
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Centricity Research
RECRUITING
Columbus
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
MetroMed Clinical Trials
RECRUITING
Chicago
Indiana
DS Research of Southern Indiana, LLC
RECRUITING
Clarksville
Kentucky
Equity Medical
RECRUITING
Bowling Green
DS Research of Kentucky, LLC
RECRUITING
Louisville
Massachusetts
Beacon Clinical Research, LLC
RECRUITING
Quincy
Michigan
Revival Research Institute, LLC
RECRUITING
Troy
Missouri
Medisearch, LLC
RECRUITING
Saint Joseph
Nebraska
Skin Specialists PC
RECRUITING
Omaha
New Mexico
University of New Mexico Department of Dermatology
RECRUITING
Albuquerque
New York
Equity Medical
RECRUITING
New York
Ohio
UC Health Physicians Office Dermatology
RECRUITING
Cincinnati
Pennsylvania
Paddington Testing, PO
RECRUITING
Philadelphia
South Carolina
Columbia Dermatology and Aesthetics
RECRUITING
Columbia
Texas
Dermatology Treatment and Research Center
RECRUITING
Dallas
Center for Clinical Studies
RECRUITING
Webster
West Virginia
West Virginia Research Institute
RECRUITING
Morgantown
Other Locations
Canada
SimcoDerm Medical and Surgical Dermatology Center
RECRUITING
Barrie
Stratica Dermatology
RECRUITING
Edmonton
Kingsway Clinical Research
RECRUITING
Etobicoke
Guelph Dermatology Research
RECRUITING
Guelph
Derm Effects
RECRUITING
London
North York Research Inc
RECRUITING
Toronto
Toronto Research Centre
WITHDRAWN
Toronto
Croatia
Special Hospital Medico
RECRUITING
Rijeka
Solmed Clinic
RECRUITING
Zagreb
Germany
Fachklinik Bad Bentheim, Klinisches Studienzentrum
RECRUITING
Bad Bentheim
Institut für Allergieforschung (IFA),Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Katholisches Klinikum Bochum
RECRUITING
Bochum
Universitätsklinikum Erlangen - Hautklinik
RECRUITING
Erlangen
Universitätsklinikum RWTH Aachen- Dermatology
RECRUITING
Frankfurt
Universtätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und
RECRUITING
Frankfurt
University Hospital Heidelberg
RECRUITING
Heidelberg
Universitätsklinikum Münster (UKM)
RECRUITING
Münster
Universitätsklinikum Tübingen - Hautklinik
RECRUITING
Tübingen
Poland
FutureMeds Gdynia
RECRUITING
Gdynia
Centrum Medyczne Pratia Katowice
RECRUITING
Katowice
Gyncentrum sp. z o.o.
RECRUITING
Katowice
Centrum Nowoczesnych Terapii Dobry Lekarz
RECRUITING
Krakow
Pratia MCM Krakόw
RECRUITING
Krakow
LUXDERM Specjalistyczny Gabinet
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
RECRUITING
Rzeszów
Clinical /research group Z.o.o.
RECRUITING
Warsaw
Gyncentrum sp. z o.o., NZOZ Gyncentrum - Oddział Warszawa
RECRUITING
Warsaw
Klinika Ambroziak Dermatologia
RECRUITING
Warsaw
DERMACEUM Centrum Badan
RECRUITING
Wroclaw
Spain
Complexo Hospitalario Universitario de Santiago de Compostela
RECRUITING
A Coruña
Hospital General Universitario Dr Balmis, ISABIAL
RECRUITING
Alicante
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
FutureMeds - Madrid
RECRUITING
Madrid
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
Madrid
FutureMeds - Sevilla
RECRUITING
Seville
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Celldex Therapeutics
clinicaltrials@celldex.com
844-723-9363
Time Frame
Start Date:2024-04-12
Estimated Completion Date:2026-06
Participants
Target number of participants:120
Treatments
Experimental: 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.
Experimental: 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.
Placebo_comparator: Placebo
Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.