ACTIVE_NOT_RECRUITING

A Study of Barzolvolimab in Patients With Prurigo Nodularis

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Conditions

Prurigo NodularisbarzolvolimabPNCDX-0159

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-04-12
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06366750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males and females, ≥18 years of age.
  2. 2. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
  3. 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.
  4. 2. An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
  5. 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.
  6. 4. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
  7. 5. Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
  8. 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.
  9. 7. Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
  10. 1. PN due to neuropathy, psychiatric disorders or medications.
  11. 2. Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
  12. 3. Active unstable pruritic skin conditions in addition to PN.
  13. 4. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
  14. 5. Females who are pregnant or nursing.
  15. 6. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
  16. 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.
  17. 8. History of anaphylaxis.
  18. 9. Prior receipt of barzolvolimab
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Total Dermatology
Birmingham, Alabama, 35203
United States
Cahaba Dermatology Skin Health Center
Birmingham, Alabama, 35244
United States
Investigate MD, LLC
Scottsdale, Arizona, 85255
United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
United States
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
United States
Profound Research LLC
Oceanside, California, 92056
United States
Empire Clinical Research
Pomona, California, 91767
United States
University of California San Francisco
San Francisco, California, 94115
United States
University of California, San Francisco
San Francisco, California, 94115
United States
Dermatology Institute & Skin Care Center
Santa Monica, California, 90404
United States
Focus Clinical Research
West Hills, California, 91307
United States
Encore Medical Research Boynton Beach
Boynton Beach, Florida, 33436
United States
Biobrilliance Medical Research Center
Hialeah, Florida, 33106
United States
Encore Medical Research
Hollywood, Florida, 33024
United States
Life Arc Research Centers Corp
Miami, Florida, 33126
United States
University of Miami
Miami, Florida, 33134
United States
Advanced Clinical Research Institute
Tampa, Florida, 33607
United States
Encore Medical Research of Weston
Weston, Florida, 33331
United States
Emory University
Atlanta, Georgia, 30322
United States
Centricity Research
Columbus, Georgia, 31904
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
MetroMed Clinical Trials
Chicago, Illinois, 60614
United States
DS Research of Southern Indiana, LLC
Clarksville, Indiana, 47129
United States
Equity Medical
Bowling Green, Kentucky, 42104
United States
DS Research of Kentucky, LLC
Louisville, Kentucky, 40241
United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169
United States
Revival Research Institute, LLC
Troy, Michigan, 48084
United States
Medisearch, LLC
Saint Joseph, Missouri, 64506
United States
Skin Specialists PC
Omaha, Nebraska, 68144
United States
University of New Mexico Department of Dermatology
Albuquerque, New Mexico, 87102
United States
Equity Medical
New York, New York, 10023
United States
Apex Clinical Research Center - Canton
Canton, Ohio, 44718
United States
UC Health Physicians Office Dermatology
Cincinnati, Ohio, 45219
United States
Paddington Testing, PO
Philadelphia, Pennsylvania, 01913
United States
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
United States
Columbia Dermatology and Aesthetics
Columbia, South Carolina, 29212
United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230
United States
Center for Clinical Studies
Webster, Texas, 77598
United States
West Virginia Research Institute
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: Celldex Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-12
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-04-12
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • barzolvolimab
  • PN
  • CDX-0159

Additional Relevant MeSH Terms

  • Prurigo Nodularis