23 Participants Needed

Secukinumab for Psoriasis

LN
HM
GY
Overseen ByGil Yosipovitch, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Research Team

GY

Gil Yosipovitch, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults aged 18-65 with psoriasis covering more than 5% of their body. They must be MRI compatible, not pregnant, fluent in English, and have had a recent TB test. Excluded are those on certain medications or with chronic diseases, drug abuse history, severe obesity, or major psychiatric disorders.

Inclusion Criteria

I don't have a pacemaker, stents, metal implants, or braces that would interfere with an MRI.
I have had a TB test within the last 8 months or need one provided.
My psoriasis affects more than 5% of my body.
See 11 more

Exclusion Criteria

I haven't started or changed doses of medications for mood, psychosis, or nerve pain in the last 3 months.
I am currently diagnosed with an active major psychiatric disorder.
I weigh 250 pounds or more.
See 21 more

Treatment Details

Interventions

  • Secukinumab
Trial OverviewThe study tests Secukinumab's effects on brain changes related to well-being perception and sensations like itch and pain in psoriasis patients. It aims to link these brain changes to the drug's impact on the IL-17 pathway.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Psoriasis GroupExperimental Treatment1 Intervention
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.
Group II: Healthy GroupActive Control1 Intervention
Healthy participants will not receive any intervention.

Secukinumab is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Cosentyx for:
  • Moderate to severe plaque psoriasis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Non-radiographic axial spondyloarthritis
🇺🇸
Approved in United States as Cosentyx for:
  • Moderate to severe plaque psoriasis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Non-radiographic axial spondyloarthritis
  • Hidradenitis suppurativa

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Novartis

Industry Sponsor

Trials
1,646
Recruited
2,778,000+
Vasant Narasimhan profile image

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye profile image

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania