Clinical Trials in the USA / NCT06366750
Active, not recruiting
Phase 2
A Study of Barzolvolimab in Patients With Prurigo Nodularis
NCT06366750 · tracked via the Priya Life Science USA tracker
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
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.
More Celldex Therapeutics trials in the USA
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Active, not recruiting
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Active, not recruiting
A Study of Barzolvolimab in Patients With Atopic Dermatitis
Active, not recruiting
Other trials for the same condition
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Active, not recruiting
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
Active, not recruiting
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 the USA