Status:
COMPLETED
A Study Examining the Medication Apremilast as Treatment for Chronic Itch
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Celgene Corporation
Conditions:
Itch
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 inflammato...
Detailed Description
There is no FDA-approved medication for chronic idiopathic pruritus (CIP). Apremilast has demonstrated notable activity and is approved for treatment in other pruritic inflammatory skin conditions suc...
Eligibility Criteria
Inclusion
- Key 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
- Key
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03239106
Start Date
December 1 2017
End Date
September 19 2019
Last Update
July 13 2021
Active Locations (1)
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1
Washington University Division of Dermatology
St Louis, Missouri, United States, 63108