Phase 2
N=10
A Study Examining the Medication Apremilast as Treatment for Chronic Itch
Itch
Bottom Line
View on ClinicalTrials.gov: NCT03239106 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Absolute NRS Itch Score at Week 16 (End of Treatment) — 7; 7.5 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Apremilast (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute NRS Itch Score at Week 16 (End of Treatment) |
7; 7.5 | — |
| SECONDARY Absolute DLQI at Week 16 |
13 | — |
| SECONDARY NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18 |
8.9; 7.9; 5.7; 6.5; 7.0; 5.7 | — |
| SECONDARY DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18 |
15.3; 13.7; 13.3; 10.8; 7.5; 4.7 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03239106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.