The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12. — From Day 1 (first dose) to Day 85 (week 12) WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
Trial sites (72)
Facility
City
Region
Status
Total Dermatology
Birmingham
Alabama
Cahaba Dermatology Skin Health Center
Birmingham
Alabama
Investigate MD, LLC
Scottsdale
Arizona
Scottsdale Clinical Trials
Scottsdale
Arizona
Center for Dermatology Clinical Research, Inc
Fremont
California
Profound Research LLC
Oceanside
California
Empire Clinical Research
Pomona
California
University of California San Francisco
San Francisco
California
University of California, San Francisco
San Francisco
California
Dermatology Institute & Skin Care Center
Santa Monica
California
Focus Clinical Research
West Hills
California
Encore Medical Research Boynton Beach
Boynton Beach
Florida
Biobrilliance Medical Research Center
Hialeah
Florida
Encore Medical Research
Hollywood
Florida
Life Arc Research Centers Corp
Miami
Florida
University of Miami
Miami
Florida
Advanced Clinical Research Institute
Tampa
Florida
Encore Medical Research of Weston
Weston
Florida
Emory University
Atlanta
Georgia
Centricity Research
Columbus
Georgia
Treasure Valley Medical Research
Boise
Idaho
MetroMed Clinical Trials
Chicago
Illinois
DS Research of Southern Indiana, LLC
Clarksville
Indiana
Equity Medical
Bowling Green
Kentucky
DS Research of Kentucky, LLC
Louisville
Kentucky
Revival Research Institute, LLC
Troy
Michigan
Medisearch, LLC
Saint Joseph
Missouri
Skin Specialists PC
Omaha
Nebraska
University of New Mexico Department of Dermatology
Albuquerque
New Mexico
Equity Medical
New York
New York
Apex Clinical Research Center - Canton
Canton
Ohio
UC Health Physicians Office Dermatology
Cincinnati
Ohio
Paddington Testing, PO
Philadelphia
Pennsylvania
Columbia Dermatology and Aesthetics
Columbia
South Carolina
International Clinical Research - Tennessee LLC
Murfreesboro
Tennessee
Dermatology Treatment and Research Center
Dallas
Texas
Center for Clinical Studies
Webster
Texas
Stratica Dermatology
Edmonton
Alberta
SimcoDerm Medical and Surgical Dermatology Center
Barrie
Ontario
Kingsway Clinical Research
Etobicoke
Ontario
+ 32 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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