A Study of CDX-0159 in Patients With Prurigo Nodularis

The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.

There is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a 16-week follow-up period after treatment. Patients will receive one dose of CDX-0159 (barzolvolimab) or placebo.

Key Inclusion Criteria:

• Males and females, 18 - 75 years old.
• Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:

• At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
• An Investigators Global Assessment (IGA) score for PN ≥ 3 at screening and Baseline (Day 1).
• 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.
• Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
• Willing to apply a topical moisturizer (emollient) twice daily throughout the study.
• 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.
• 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:

• PN due to neuropathy, psychiatric disorders or medications.
• Unilateral lesions of prurigo (eg, only one arm affected)
• Active unstable pruritic skin conditions in addition to PN.
• Women who are pregnant or nursing.
• Known hepatitis B or hepatitis C infection or active COVID-19 infection
• 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.
• History of anaphylaxis.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.