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ACTIVE NOT RECRUITING

NCT06366750

PHASE2

A Study of Barzolvolimab in Patients With Prurigo Nodularis

Sponsor: Celldex Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.

Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Patients With Prurigo Nodularis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-04-12

Completion Date

2027-03

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Prurigo Nodularis

Interventions

BIOLOGICAL

barzolvolimab

subcutaneous administration

OTHER

Matching Placebo

subcutaneous administration

Key Inclusion Criteria: 1. Males and females, ≥18 years of age. 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. Key Exclusion Criteria 1. PN due to neuropathy, psychiatric disorders or medications. 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.

Locations (72)

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

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

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

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

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 de la Santa Creu i Sant Pau

Barcelona, Spain

FutureMeds - Madrid

Madrid, Spain

FutureMeds - Sevilla

Seville, Spain

Clinical Research Directory

A Study of Barzolvolimab in Patients With Prurigo Nodularis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (72)