Safety and Efficacy of CC-10004 for Prurigo Nodularis

Inclusion Criteria

• •Must understand and voluntarily sign an informed consent form
• •Must be male or female and aged ≥ 18 years at time of consent
• •Must be able to adhere to the study visit schedule and other protocol requirements
• •Must have a diagnosis of prurigo nodularis based on clinical and histological findings and have failed four weeks of treatment with topical therapies, including corticosteroids and/or vitamin D derivatives.
• •Must meet the following laboratory criteria:
• •* Hemoglobin WNL
• •* Hematocrit WNL
• •* White blood cell (WBC) count WNL
• •* Neutrophils ≥ 1500 /dL
• •* Platelets ≥ 100,000 /dL
• •* Serum creatinine ≤ 1.5 mg/dL
• •* Total bilirubin 2.0 mg/dL
• •* Aspartate transaminase (AST \[serum glutamic oxaloacetic transaminase, SGOT\]) and alanine transaminase (ALT \[serum glutamate pyruvic transaminase, SGPT\]) 1.5x upper limit of normal (ULN)
• •Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.
• •Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.