Safety and Efficacy of CC-10004 for Prurigo Nodularis
Condition: Prurigo Nodularis
MeSH terms: Prurigo; Neurodermatitis
Intervention: CC-10004
Intervention description: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PN

Summary:

      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.
    

Eligibility criteria:

        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.