A Study Examining the Medication Apremilast as Treatment for Chronic Itch

• Status: Completed
• Trial end date: 2019-09-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Celgene Corporation
• Treatments: Apremilast; Thalidomide

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.