A Study of Barzolvolimab in Patients With Prurigo Nodularis

Launched by CELLDEX THERAPEUTICS · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called barzolvolimab for adults with prurigo nodularis, a condition that causes itchy, raised nodules on the skin. The main goal is to see how effective and safe this treatment is for people suffering from this condition. The trial is currently looking for participants aged 18 and older who have been diagnosed with prurigo nodularis and are experiencing severe itching. To be eligible, you should have at least 20 nodules on your body and have not responded well to other topical treatments.

If you join the study, you’ll be asked to apply a moisturizer daily and keep a diary of your symptoms throughout the trial. The study will involve regular visits to the clinic where your progress will be monitored. It’s important to know that there are specific health conditions and medications that may prevent you from participating, so your study doctor will carefully review your medical history to determine if you qualify. This trial offers hope for better management of prurigo nodularis, and your participation could help advance understanding of this condition.

Gender

ALL

Eligibility criteria

• 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.