Analysis of the Pathogenesis of Itch in Response to Apremilast Therapy in Psoriasis Patients
- Sponsor
- Diamant Thaci
- Study ID
- NCT03146247
- Phase
- PHASE4
- Status
- Withdrawn
Conditions
- Moderate to Severe Plaque Psoriasis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet — DRUGAll patients are scheduled to receive Apremilast with a titration phase of one week, followed by 23 weeks of regular treatment.
Study Details
This study aims to identify and describe the presence of itch active molecules in psoriasis and response to treatment with apremilast. This data will be complemented by immunohistochemical data determining nerve ending density and neuropeptide concentrations before and during treatment and correlated with patient reported outcome. It is important to underscore that itch may interfere with various aspects of patient functioning, emotions and social status and should therefore be adequately addressed while treating patients with psoriasis
Key Dates
- First listed
- May 9, 2017
- Start date
- Oct 23, 2017
- Status verified
- Apr 2019
- Primary completion
- Mar 1, 2019
- Completion
- Mar 1, 2019
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Other: One armall patients receive same dose and dosing regimen with Apremilast
Primary Outcome Measure
Immunoreactive nerve fibers [ Time Frame: until week 16 ]
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