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.

Exclusion criteria

• History of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant by the investigator
• Any systemic treatment (including ultraviolet light, corticosteroids, thalidomide, azathioprine, cyclosporine) within 28 days of study drug administration.
• Any topical treatments (including corticosteroids, vitamin D derivatives) within 14 days of study drug initiation.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Pregnant or lactating female.