Secukinumab for Psoriasis

Overseen By Gil Yosipovitch, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Antihistamines, Opioids, Biologics, others

Disqualifiers: Chronic infections, Major psychiatric disorders, Morbid obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

20 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Gil Yosipovitch, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Psoriasis participants receive Secukinumab, a 300mg subcutaneous injection, at weeks 0, 1, 2, 3, 4, 8, and 12

16 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Secukinumab

Trial Overview 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.

How Is the Trial Designed?

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

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

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

Novartis

Chief Medical Officer since 2022

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