20 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

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?

GY

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.
See 9 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 20 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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Psoriasis GroupExperimental Treatment1 Intervention
Group II: Healthy GroupActive Control1 Intervention

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

🇪🇺
Approved in European Union as Cosentyx for:
🇺🇸
Approved in United States as Cosentyx for:

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

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