A Study Examining the Medication Apremilast as Treatment for Chronic Itch (NCT03239106) | Clinical Trial Compass
CompletedPhase 2
A Study Examining the Medication Apremilast as Treatment for Chronic Itch
United States10 participantsStarted 2017-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Absolute NRS Itch Score at Week 16 (End of Treatment)