Safety and Efficacy of CC-10004 for Prurigo Nodularis

An Open Label, Single Center Study to Assess the Safety and Efficacy of a 24 Week Treatment Course of CC-10004 in Adults With Recalcitrant Nodularis

This trial will include:

• Study period up to 7 months.
• Office visits monthly lasting approximately 1 hour.
• Blood Draws.
• Oral medication that is taken 2 times daily.
• Photographs and biopsies if agreed.

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.