The purpose of this study is to assess the effect of a biologic drug targeting the Interleukin (IL)-17 pathway (secukinumab) on brain plasticity and examine whether the plastic changes correlate with the improvement of perception of well-being, itch, and pain in participants with psoriasis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
300mg subcutaneous injection
University of Miami
Miami, Florida, United States
Change in Gray Matter Density
Change in brain anatomy for participants will be reported as the change in average gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans from baseline to week 4
Time frame: Baseline to Week 4 (Visit 3)
Change in Brain Activity
Changes in brain activity in participants will be measured using Arterial Spin Labeling (ASL) MRI from baseline to week 4. ASL quantifies cerebral blood flow CBF in units of ml/100g/min (milliliters of blood per 100 grams of tissue per minute).
Time frame: Baseline to Week 4 (Visit 3)
Change in Itch Score as Measured by the NRS
Itch will be measured using the Numerical Rating Scaling (NRS) ranging from 0 (no itch) to 10 (the worst itch imaginable) baseline to week 4 in psoriasis participant group only.
Time frame: Baseline to Week 4 (Visit 3)
Change in Pain Score as Measured by the NRS
Pain will be measured using a Numerical Rating Scaling (NRS) ranging from 0 (no pain) to 10 (the worst pain imaginable) baseline to week 4 in psoriasis participant group only.
Time frame: Baseline to Week 4 (Visit 3)
Change in PASI Scores
Severity of psoriasis will be measured using the Psoriasis Area and Severity Index (PASI), ranging from 0 to 100 with a higher score indicating more severe psoriasis, from baseline to week 4 in psoriasis participant group only.
Time frame: Baseline to Week 4 (Visit 3)
Change in Participant Well-being as Measured by WHO-5
Well-being will be measured using the 5-item World Health Organization Well-Being Index (WHO-5), ranging from 0 to 25 with a higher score indicating better well-being, from baseline to week 4.
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Time frame: Baseline to Week 4 (Visit 3)
Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores
Changes in participants' quality of sleep by using the Numerical Rating Scaling (NRS) ranging from 0 to 10, with a higher score indicating lower sleep quality between baseline, from baseline to week 4.
Time frame: Baseline to Week 4 (Visit 3)
Change in Physical Activity as Measured by 7D-PAR
Physical activity will be measured using the 7-days physical activity recall (7D-PAR), with 0 denoting no exercise and a higher score indicating more physical activity (there is not cap for this score), from baseline to week 4.
Time frame: Baseline to Week 4 (Visit 3)
Changes in Stress in Daily Life as Measured by PSQ
Stress in daily life in psoriasis participants will be measured using the Perceived Stress Questionnaire (PSQ), ranging from 0 to 1 with a higher score indicating more stress, from baseline to week 4.
Time frame: Baseline, Up to Week 4 (Visit 3)