Brain Changes in Psoriasis After Secukinumab Treatment

NCT04717466 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20200857
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis; Healthy

Outcome Measures

Primary Outcomes (2)

• Change in Gray Matter Density

  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

  Baseline to Week 4 (Visit 3)

• Change in Brain Activity

  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).

  Baseline to Week 4 (Visit 3)

Secondary Outcomes (7)

• Change in Itch Score as Measured by the NRS

  Baseline to Week 4 (Visit 3)

• Change in Pain Score as Measured by the NRS

  Baseline to Week 4 (Visit 3)

• Change in PASI Scores

  Baseline to Week 4 (Visit 3)

• Change in Participant Well-being as Measured by WHO-5

  Baseline to Week 4 (Visit 3)

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

  Baseline to Week 4 (Visit 3)

Study Arms (2)

Psoriasis Group

EXPERIMENTAL

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

Healthy Group

NO INTERVENTION

Healthy participants will not receive any intervention.

Interventions

Secukinumab BIOLOGICAL

300mg subcutaneous injection

Psoriasis Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Novartis: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Hideki Mochizuki
• Organization: University of Miami

hxm414@med.miami.edu

305-234-4472

Study Officials

• Gil Yosipovitch, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 22, 2021
• Study Start: June 29, 2021
• Primary Completion: May 16, 2024
• Study Completion: March 4, 2025
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)