A Study of Barzolvolimab in Patients with Prurigo Nodularis

Eligibility 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.
• 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