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OpenTrials
Completed

NCT Number: NCT04717466

Brain Changes in Psoriasis After Secukinumab Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secukinumab

Biological

300mg subcutaneous injection

Primary outcomes

  1. Change in Gray Matter Density

    Time frame: 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

  2. Change in Brain Activity

    Time frame: 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).

Secondary outcomes

  1. Change in Itch Score as Measured by the NRS

    Time frame: 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.

  2. Change in Pain Score as Measured by the NRS

    Time frame: 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.

  3. Change in PASI Scores

    Time frame: 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.

  4. Change in Participant Well-being as Measured by WHO-5

    Time frame: 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.

  5. Change in Quality of Sleep as Measured by a Sleep Numerical Rating Scale Scores

    Time frame: 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.

  6. Change in Physical Activity as Measured by 7D-PAR

    Time frame: 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.

  7. Changes in Stress in Daily Life as Measured by PSQ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 22, 2021
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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