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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how secukinumab (also known as Cosentyx or AIN457), which targets a specific part of the immune system, can improve well-being, itch, and pain in people with psoriasis. Researchers aim to determine if brain changes are linked to these improvements. Individuals with psoriasis covering more than 5% of their skin and who have recently had a TB test might be suitable for this trial. Participants will receive the treatment through a series of injections over four months. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot participate if you recently started or changed the dose of certain medications like antidepressants, or if you use opioids or antihistamines. If you have used biologics or Otezla recently, you may also be excluded.

What is the safety track record for Secukinumab?

Research has shown that secukinumab is generally safe for people with psoriasis. Most studies indicate that it does not cause severe side effects for most users. However, some reports have noted increased inflammation issues. While serious side effects are rare, some individuals might experience mild to moderate ones. Secukinumab is already approved for treating psoriasis, supporting its safety.

For those considering joining a trial with secukinumab, these findings can offer reassurance about its safety. However, discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Secukinumab is unique because it specifically targets interleukin-17A, a protein that plays a significant role in the inflammatory process of psoriasis. Unlike other treatments such as topical corticosteroids or phototherapy, secukinumab is a biologic medication administered as a subcutaneous injection, which can be more convenient for patients who struggle with daily topical applications. Researchers are excited about secukinumab because it has demonstrated the potential to provide rapid and sustained improvement in psoriasis symptoms, offering a promising alternative for those who don't respond well to existing therapies.

What is the effectiveness track record for Secukinumab in treating psoriasis?

Research has shown that secukinumab, which participants in this trial may receive, effectively treats moderate-to-severe psoriasis. Studies have demonstrated that it quickly and significantly improves psoriasis symptoms. In one study, people using secukinumab saw a 63% improvement in their symptoms by Week 12, compared to a 31% improvement with a placebo. Another study found that it provides lasting benefits for people with psoriasis. Overall, strong evidence supports secukinumab's ability to help manage psoriasis. ^{1 3 6 7 8}

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9453482/

Evaluation of the efficacy, safety, and side effects ... Conclusions. These findings suggest that secukinumab therapy is reasonably effective in patients with moderate-to-severe psoriasis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05320159

Treatment Effectiveness Among Psoriasis Patients Treated ... Study Overview​​ Psoriasis (PsO) patients initiating secukinumab were identified and indexed to the first secukinumab use using the most recent data at study ...

3. cosentyxhcp.com cosentyxhcp.com/rheumatology/psoriatic-arthritis-efficacy/psa-manifestations

Efficacy in PsA Manifestations | COSENTYX® (secukinumab) MAXIMISE primary end point: 63% experienced relief on COSENTYX 300 mg at Week 12 vs 31% with placebo, as measured by ASAS20 (P<0.0001) (n=164) (MI).8. Nail data ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9884729/

Long-Term Effectiveness and Drug Survival of ... Secukinumab has demonstrated rapid, significant and sustained long-term improvements across various manifestations of psoriasis in several clinical trials.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1297319X24001350

Four-year secukinumab treatment outcomes in European ... The overall 24-/48-month secukinumab retention rates were 61%/51% in 767 axSpA patients, and 64%/49% in 975 PsA patients, respectively. Compared to b/tsDMARD ...

6. nature.com nature.com/articles/s41598-023-50013-7

Assessment of safety profile of secukinumab in real-world ... Secukinumab has elicited a favorable safety profile in clinical trials, but concerns have been raised with higher incidences of inflammatory ...

7. novartis.com novartis.com/us-en/news/media-releases/novartis-presents-cosentyxtm-two-year-efficacy-and-safety-data-showing-sustainable-effect-psoriasis-patients

Novartis presents Cosentyx™ two-year efficacy and safety ... New data at AAD shows 7 out of 10 psoriasis patients who were PASI 75 responders at 52 weeks achieved clear to almost clear skin (PASI 90) after two years ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01358578

NCT01358578 | Safety and Efficacy of Secukinumab ... Study Overview. Brief Summary. This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate ...