A Study Examining the Medication Apremilast as Treatment for Chronic Itch
Condition: Itch
MeSH terms: Pruritus
Intervention: Apremilast
Intervention description: Apremilast 30 mg BID daily
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open label
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: itch; pruritus; CIP

Summary:

      Chronic Itch is a debilitating condition affecting many people. Currently, there are no
      FDA-approved treatments. Apremilast is an FDA-approved oral medication used to successfully
      treat the inflammatory skin disorder psoriasis and the inflammatory disorder psoriatic
      arthritis. This study examines if apremiliast taken twice daily relieves chronic itch.
    

Eligibility criteria:

        Inclusion Criteria:

        Key Inclusion Criteria: A subject who meets all of the following criteria may be included
        in the study:

          -  Male and non-pregnant, non-lactating female subjects aged 18 years or older

          -  Diagnosed with chronic idiopathic pruritus (CIP) with an NRS Itch Score of ≥ 7 at both
             Screening and Baseline

          -  Diagnosis of CIP for at least 6 weeks prior to screening

          -  Willingness to avoid pregnancy or fathering of children

          -  Ability and willingness to provide written informed consent

          -  Willing and able to comply with all study requirements and restrictions

          -  Willing to not participate in any other interventional trial for the duration of their
             participation

          -  Subjects must be in good health as determined by medical history, physical
             examination, electrocardiogram, clinical laboratory tests and vital signs

          -  Failure of a course 2-week course of treatment with topical triamcinolone 0.1%
             ointment BID

          -  Histopathological demonstration of skin eosinophils, mast cell activation, lymphocytic
             infiltration, and/or dermal edema

        Exclusion Criteria:

        Key Exclusion Criteria: A subject who meets any of the following criteria will be excluded
        from the study:

          -  Chronic pruritus due to a defined primary dermatologic disorder (e.g., atopic
             dermatitis, psoriasis, etc.)

          -  Patients with a prior diagnosis of excoriation disorder

          -  Use of topical treatments for CIP (other than bland emollients) within 1 week of
             Baseline

          -  Systemic immunosuppressive or immunomodulating drugs within 4 weeks of Baseline

          -  Subjects with cytopenias at screening, defined as:

               -  Leukocytes < 3 × 109/L.

               -  Neutrophils < lower limit of normal.

               -  Lymphocytes < 0.5 × 109/L

               -  Hemoglobin < 10 g/dL.

               -  Platelets < 100 × 109/L.

          -  Unwilling or unable to follow medication restrictions described in Section 5.6.3, or
             unwilling or unable to sufficiently washout from use of restricted medication

          -  Under medical treatment for a skin disease with a therapy listed in the prohibited
             medications section that may influence the results of the study

          -  Current clinically significant cardiovascular, respiratory, neurologic, hepatic,
             hematopoietic, renal gastrointestinal, endocrine or metabolic dysfunction unless
             currently controlled and stable, including (but not limited to) the following:
             Positive for Hepatitis C antibody test (anti-HCF) Positive for hepatitis B surface
             antigen (HBsAg) or hepatitis B core antibody (HBcAb) Positive for HIV (DUO test, p24
             antigen)

          -  Active malignancy

          -  Active substance abuse or history of substance abuse within 6 months of screening

          -  History (including family history) or current evidence of congenital long QT syndrome
             or known acquired QT prolongation

          -  Exposure to any investigational medication, including placebo, within 60 days of the
             Baseline Visit

          -  Subjects who had previously received apremilast

          -  Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal
             disease on dialysis or at least 1 of the following:

               -  Serum creatinine > 1.5 mg/dL

               -  Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of
                  normal

          -  Anyone affiliated with the site or sponsor and/or anyone who may consent under duress

          -  Any other sound medical reason as determined by the Investigator including any
             condition which may lead to an unfavorable risk-benefit of study participation, may
             interfere with study compliance or may confound results.