Brain Changes in Psoriasis After Secukinumab Treatment
- Registration Number
- NCT04717466
- Lead Sponsor
- University of Miami
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psoriasis Group Secukinumab Psoriasis participants will be given Secukinumab for a total of 4 months. This is a 300mg subcutaneous injection that will occur at weeks 0, 1, 2, 3, 4, 8, and 12.
- Primary Outcome Measures
Name Time Method Change in Brain Activity Baseline to Week 4 (Visit 3) 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).
Change in Gray Matter Density Baseline to Week 4 (Visit 3) 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
- Secondary Outcome Measures
Name Time Method Change in Itch Score as Measured by the NRS Baseline to Week 4 (Visit 3) 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.
Change in Pain Score as Measured by the NRS Baseline to Week 4 (Visit 3) 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.
Change in PASI Scores Baseline to Week 4 (Visit 3) 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.
Change in Participant Well-being as Measured by WHO-5 Baseline to Week 4 (Visit 3) 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.
Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores Baseline to Week 4 (Visit 3) 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.
Change in Physical Activity as Measured by 7D-PAR Baseline to Week 4 (Visit 3) 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.
Changes in Stress in Daily Life as Measured by PSQ Baseline, Up to Week 4 (Visit 3) 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.
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States
University of Miami🇺🇸Miami, Florida, United States