Brain Changes in Psoriasis After Secukinumab Treatment

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717466
• Other study ID #: 20200857
• Status: Recruiting
• Phase: Phase 4
• Start date: June 29, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: Hideki Mochizuki, PhD
• Phone: 305-243-1648
• Email: hxm414[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion:

1. Between 18 and 65 years of age.

2. Psoriasis patients (with/without psoriatic arthritis): Psoriasis Area (BSA) is more than 5%.

3. 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).

4. 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.

5. Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.

6. 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.

7. Participants have to be able to speak and read English fluently.

8. Participants must have signed a written informed consent before being enrolled in the study

Exclusion:

1. Individuals under 18 or over 65 years of age.

2. Inability to complete the required measures.

3. Participants who use antihistamine drugs for itch relief

4. Suffering from any disease state or physical condition, which would increase their health risk by study participation.

5. Patients with chronic infectious diseases (e.g., mycobacterial and fungal infections and chronic tuberculosis) or inflammatory bowel disease.

6. Patients without a negative TB test in the past 12 months.

7. Hypersensitivity or anaphylaxis to biologics

8. 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.

9. Patients with primary immunodeficient lacking IL-17, patients with autoantibodies against IL-17

10. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.

11. Recent initiation (within last 3 months) or change in dose of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.

12. Patients who were previously treated with drugs targeting IL-17

13. Patients who have used biologics in the past in the past 8 weeks or Otezla in the past 4 weeks.

14. 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.

15. Current treatment with opioid analgesics.

16. Uncontrolled thyroid disease.

17. Use of illicit drugs or history of opiate addiction.

18. Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active currently.

19. Morbid obesity

20. Weight: 250 lb or more

21. 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).

22. Inability to speak and read English.

23. Pregnant.

24. Incarcerated.

Related Conditions & MeSH terms

• Healthy
• Psoriasis

Intervention

Biological:
• Secukinumab
300mg subcutaneous injection

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)