Brain Changes in Psoriasis After Secukinumab Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Brain Morphological Changes Accompanied by Effective Biologic Treatments for Psoriasis and Their Associations With the Improvement of Well-being, Itch, and Pain

Conditions
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Psoriasis, Healthy

Intervention / Treatment
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* Biological: Secukinumab


Participation Criteria
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Eligibility Criteria
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Inclusion: Between 18 and 65 years of age. Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more than 5%. Psoriasis patients must have had a TB test in the past 8 months (if a patient has not had one, the study will provide one). Healthy subjects: in general, good health without history of neurological and psychiatric diseases. No chronic itch, pain, skin or systemic conditions currently or in the past. Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant. MRI Compatibility: No major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form. Participants have to be able to speak and read English fluently. Participants must have signed a written informed consent before being enrolled in the study Exclusion: Individuals under 18 or over 65 years of age. Inability to complete the required measures. Participants who use antihistamine drugs for itch relief Suffering from any disease state or physical condition, which would increase their health risk by study participation. Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections and chronic tuberculosis) or inflammatory bowel disease. Patients without a negative TB test in the past 12 months. Hypersensitivity or anaphylaxis to biologics Patients with treatment of biologics should not receive live vaccines. Thus, age appropriate immunizations according to current immunization guidelines must be completed before the experiment. Patients with primary immunodeficient lacking IL-17, patients with autoantibodies against IL-17 Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy. Recent initiation (within last 3 months) or change in dose of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications. Patients who were previously treated with drugs targeting IL-17 Patients who have used biologics in the past in the past 8 weeks or Otezla in the past 4 weeks. Patients who use centrally acting agents only when they need. The purpose is to avoid a risk of acute effect of these agents on brain activity. Current treatment with opioid analgesics. Uncontrolled thyroid disease. Use of illicit drugs or history of opiate addiction. Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active currently. Morbid obesity Weight: 250 lb or more Any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., HIV, Hepatitis C, etc). Inability to speak and read English. Pregnant. Incarcerated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psoriasis Group<br>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. | Biological: Secukinumab<br>* 300mg subcutaneous injection<br>|
| No Intervention: Healthy Group<br>Healthy participants will not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gray matter density | Changes in brain anatomy for psoriasis participants will be reported as the change in gray matter density as measured by Voxel Based Morphometry (VBM) analysis of Magnetic Resonance Imaging (MRI) scans | Baseline, Up to Week 4 (Visit 3) | 
| Change in brain activity | Changes in brain activity in psoriasis participants will be measured using Arterial Spin Labeling (ASL) MRI | Baseline, Up to Week 4 (Visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, Up 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, Up 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. | Baseline, Up 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. | Baseline, Up to Week 4 (Visit 3) | 
| Change in quality of sleep as measured by PSQI scores | Quality of sleep will be measured using the Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 49, with a higher score indicating lower sleep quality. | Baseline, Up 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), ranging from 0 to 27, with a higher score indicating more physical activity. | Baseline, Up 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. | Baseline, Up to Week 4 (Visit 3) |