Secukinumab for Psoriasis

Recruiting in Palo Alto (17 mi)

Overseen by Gil Yosipovitch, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

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.

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.

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.

Participant Groups

The 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.

Group I: Psoriasis Group Experimental Treatment 1 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 Group Active Control 1 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

Research Locations Nearby Select from list below to view details:

University of Miami Miami, FL

Who Is Running the Clinical Trial?

University of Miami Lead Sponsor

Novartis Industry Sponsor

References