Brain Changes in Psoriasis After Secukinumab Treatment

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04717466
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Miami
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gil Yosipovitch, MD
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Healthy
Arms & Interventions

Arms

Experimental: Psoriasis Group

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.

No Intervention: Healthy Group

Healthy participants will not receive any intervention.

Interventions

Biological: - Secukinumab

300mg subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Hideki Mochizuki, PhD

hxm414@med.miami.edu

305-243-1648

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