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Clinical Trials in Germany / NCT06366750
Active, not recruiting Phase 2

A Study of Barzolvolimab in Patients With Prurigo Nodularis

NCT06366750 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2024-04-12
Last updated
2026-08-04

Condition(s) studied

Prurigo Nodularis

Investigational drug(s) / intervention(s)

barzolvolimab →Matching Placebo

barzolvolimab: subcutaneous administration

Matching Placebo: subcutaneous administration

Study summary

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)

Trial sites (72)

FacilityCityRegionStatus
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.

More Celldex Therapeutics trials in Germany

Other trials for the same condition

Official registry record

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.

View NCT06366750 on ClinicalTrials.gov ↗ ← All trials in Germany