Brain Changes in Psoriasis After Secukinumab Treatment

Phase 4

Active, not recruiting

• Conditions: Psoriasis; Healthy

• Registration Number: NCT04717466
• Lead Sponsor: University of Miami

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-1-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion:<br><br> 1. Between 18 and 65 years of age.<br><br> 2. Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more<br> than 5%.<br><br> 3. Psoriasis patients must have had a TB test in the past 8 months (if a patient has<br> not had one, the study will provide one).<br><br> 4. Healthy subjects: in general, good health without history of neurological and<br> psychiatric diseases. No chronic itch, pain, skin or systemic conditions currently<br> or in the past.<br><br> 5. Women of child bearing potential will be administered a pregnancy test to verify<br> that they are not pregnant.<br><br> 6. MRI Compatibility: No major contraindication for MRI (pacemaker, vascular stents,<br> metallic ear tubes, and absence of metal implants or braces) as assessed by MRI<br> technologist using site approved screening form.<br><br> 7. Participants have to be able to speak and read English fluently.<br><br> 8. Participants must have signed a written informed consent before being enrolled in<br> the study<br><br>Exclusion:<br><br> 1. Individuals under 18 or over 65 years of age.<br><br> 2. Inability to complete the required measures.<br><br> 3. Participants who use antihistamine drugs for itch relief<br><br> 4. Suffering from any disease state or physical condition, which would increase their<br> health risk by study participation.<br><br> 5. Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections<br> and chronic tuberculosis) or inflammatory bowel disease.<br><br> 6. Patients without a negative TB test in the past 12 months.<br><br> 7. Hypersensitivity or anaphylaxis to biologics<br><br> 8. Patients with treatment of biologics should not receive live vaccines. Thus, age<br> appropriate immunizations according to current immunization guidelines must be<br> completed before the experiment.<br><br> 9. Patients with primary immunodeficient lacking IL-17, patients with autoantibodies<br> against IL-17<br><br> 10. Currently enrolled in any investigational study in which the subject is receiving<br> any type of drug, biological, or non-drug therapy.<br><br> 11. Recent initiation (within last 3 months) or change in dose of centrally acting<br> agents such as antidepressants, neuroleptics or neuropathic medications.<br><br> 12. Patients who were previously treated with drugs targeting IL-17<br><br> 13. Patients who have used biologics in the past in the past 8 weeks or Otezla in the<br> past 4 weeks.<br><br> 14. Patients who use centrally acting agents only when they need. The purpose is to<br> avoid a risk of acute effect of these agents on brain activity.<br><br> 15. Current treatment with opioid analgesics.<br><br> 16. Uncontrolled thyroid disease.<br><br> 17. Use of illicit drugs or history of opiate addiction.<br><br> 18. Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or<br> bipolar disorder that is active currently.<br><br> 19. Morbid obesity<br><br> 20. Weight: 250 lb or more<br><br> 21. Any known diseases or disorders that may affect conducting the experiments (e.g.,<br> intracranial pathology, claustrophobia, severe respiratory or cardiovascular<br> problems, active fibromyalgia) or diseases that have potential risks of infections<br> (e.g., HIV, Hepatitis C, etc).<br><br> 22. Inability to speak and read English.<br><br> 23. Pregnant.<br><br> 24. Incarcerated.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in gray matter density;Change in brain activity

Secondary Outcome Measures

Name	Time	Method
Change in itch score as measured by the NRS;Change in pain score as measured by the NRS;Change in PASI scores;Change in participant well-being as measured by WHO-5;Change in quality of sleep as measured by PSQI scores;Change in physical activity as measured by 7D-PAR;Changes in stress in daily life as measured by PSQ