Secukinumab for Nail Psoriasis

Overseen By Sarah Gillespie, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Pennsylvania

Must not be taking: IL-17 inhibitors

Disqualifiers: Inflammatory bowel disease, Active infection, 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: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests secukinumab (also known as Cosentyx or AIN457), a treatment already approved for psoriasis, to evaluate its effectiveness on nail psoriasis. Researchers aim to determine how quickly the treatment can improve nail health and explore various methods to measure this improvement. The trial is open to individuals with nail psoriasis affecting four or more fingernails who have either had skin psoriasis in the past or currently have it. It is ideal for those who have not used certain psoriasis drugs before and do not have conditions like inflammatory bowel disease or active infections. As a Phase 4 trial, this research seeks to understand how an FDA-approved and proven treatment can benefit more patients with nail psoriasis.

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

The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have used IL-17 inhibitors before, so you might need to discuss your current medications with the trial team.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have used IL-17 inhibitors before, so you may need to discuss your current medications with the trial team.

What is the safety track record for secukinumab?

Research has shown that secukinumab is generally safe for people with psoriasis. Studies have found that most people tolerate it well, indicating a good safety record. Although concerns about inflammation have arisen, they are rare. The FDA has approved this treatment for psoriasis, confirming its safety through thorough review. In real-world use and long-term studies, secukinumab continues to demonstrate a strong safety record, suggesting it is a dependable option for treating nail psoriasis. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Secukinumab is unique because it specifically targets interleukin-17A, a protein involved in inflammatory processes, which is not the focus of most current treatments for nail psoriasis. While traditional therapies, like topical steroids and systemic treatments, aim to broadly reduce inflammation, Secukinumab offers a more targeted approach, potentially leading to more effective results with fewer side effects. Researchers are excited about this treatment because it has shown promise in other psoriasis forms, and its targeted mechanism could revolutionize how we address nail psoriasis.

What is the effectiveness track record for secukinumab in treating nail psoriasis?

Studies have shown that secukinumab, which participants in this trial will receive, effectively treats nail psoriasis. It improved nail symptoms within 12 weeks, with even better results after 24 weeks. Research indicates that the benefits can last for over 2.5 years, significantly enhancing nail appearance. In one study, secukinumab reduced the severity of nail psoriasis by up to 73.3%. This treatment is already approved for psoriasis, providing strong evidence of its effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

Alexis Ogdie-Beatty, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with active skin psoriasis or a history of it, and significant nail psoriasis. It's not open to those with fungal nail infections, inflammatory bowel disease, metal implants affecting MRI use, current infections, or past IL-17 inhibitor treatments.

Inclusion Criteria

I have or had skin psoriasis diagnosed by a dermatologist.

I have psoriasis affecting 4 or more of my fingernails.

Exclusion Criteria

I have used IL-17 inhibitors before, but other treatments are okay.

I have a history of psoriatic arthritis but it's not active now.

I do not have a fungal nail infection on my fingernails.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive secukinumab for the treatment of nail psoriasis

24 weeks

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 (an FDA-approved psoriasis medication) specifically on nail psoriasis. Participants will self-administer the drug using an auto-injector and researchers will monitor how quickly and effectively the treatment works.

How Is the Trial Designed?

Group I: Open Label Experimental Treatment 1 Intervention

Secukinumab

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 Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

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

Published Research Related to This Trial

In a case series of 15 patients with moderate to severe plaque psoriasis and nail psoriasis, treatment with secukinumab led to significant improvements in both skin and nail conditions, with a 75% reduction in PASI and 50% reduction in NAPSI after 6 weeks.

By week 12, patients experienced even greater improvements, with an 80% reduction in nail psoriasis severity and a 90% reduction in skin severity, demonstrating secukinumab's efficacy for patients who did not respond to traditional topical therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab efficacy in the treatment of nail psoriasis: a case series. Pistone, G., Gurreri, R., Tilotta, G., et al.[2019]

Secukinumab significantly improved nail psoriasis severity and quality of life in patients with psoriatic arthritis, showing a marked reduction in the modified Nail Psoriasis Severity Index (mNAPSI) score at Week 16 compared to placebo, with effects sustained through Week 104.

The treatment also demonstrated a low rate of radiographic progression, with 91.9% of patients on the 300 mg dose showing no significant changes in joint damage after 2 years, indicating both efficacy and safety in managing psoriatic arthritis with nail involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab provides sustained improvement in nail psoriasis, signs and symptoms of psoriatic arthritis and low rate of radiographic progression in patients with concomitant nail involvement: 2-year results from the Phase III FUTURE 5 study. Nash, P., Mease, PJ., Kirkham, B., et al.[2022]

Secukinumab, an IL-17 inhibitor, has shown significant efficacy and safety in treating psoriasis and psoriatic arthritis, based on results from seven phase III and five phase II clinical trials involving various patient populations.

The treatment led to rapid clinical improvement, with a favorable safety profile, where common side effects included nasopharyngitis and upper respiratory infections, indicating it is a promising option for patients who do not respond to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab in the Treatment of Psoriasis and Psoriatic Arthritis: A Review of the Literature. Abrouk, M., Gandy, J., Nakamura, M., et al.[2019]

Secukinumab (Cosentyx™) is a fully human monoclonal antibody that targets interleukin-17A, approved for treating psoriasis and psoriatic arthritis in adults who do not respond adequately to other systemic therapies.

It received its first global approval in Japan in December 2014 and was subsequently approved in the USA and EU in early 2015, with ongoing investigations for additional conditions like ankylosing spondylitis and rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: first global approval. Sanford, M., McKeage, K.[2019]

Secukinumab is an effective treatment for psoriatic arthritis (PsA), showing improvements in skin symptoms, enthesitis, dactylitis, and preventing the progression of joint damage, based on clinical studies.

The treatment is generally well tolerated, with common side effects including nasopharyngitis, headache, and upper respiratory infections, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab for the treatment of psoriatic arthritis. Baronaite Hansen, R., Kavanaugh, A.[2019]

Secukinumab demonstrated consistent and sustained effectiveness in clearing nail psoriasis in patients with psoriatic arthritis, regardless of the severity of nail involvement.

The reduction in nail disease was linked to improvements in all musculoskeletal and skin symptoms associated with psoriatic arthritis, indicating a comprehensive therapeutic benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab demonstrates high and sustained efficacy in nail psoriasis: post hoc analysis from phase III trials in patients with psoriatic arthritis. Reich, K., Baraliakos, X., Coates, LC., et al.[2022]

Secukinumab, a monoclonal antibody targeting IL-17A, has shown significant efficacy in improving symptoms of psoriatic arthritis in Phase III clinical trials, even in patients who had previously not responded to other treatments like NSAIDs or DMARDs.

The treatment is generally well tolerated, with mild to moderate infections being the most common side effects, making it a viable alternative to existing therapies such as tumor necrosis factor inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. Shirley, M., Scott, LJ.[2019]

Nail psoriasis affects a significant number of patients with skin psoriasis and psoriatic arthritis, making effective treatment crucial, especially since nails are hard to treat and often relapse occurs.

Secukinumab, an IL-17A targeting monoclonal antibody, is the only systemic treatment specifically studied for nail psoriasis, showing the highest efficacy at week 16 in the TRANSFIGURE trial, which highlights its potential as a leading option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nail Psoriasis: An Updated Review and Expert Opinion on Available Treatments, Including Biologics. Bardazzi, F., Starace, M., Bruni, F., et al.[2020]

Secukinumab is a highly effective first-line treatment for moderate to severe plaque psoriasis, outperforming both placebo and other biologics like etanercept and ustekinumab in clinical trials.

The treatment is generally well tolerated with low immunogenicity, and its efficacy is sustained over the long term, making it a valuable option for patients with difficult-to-treat psoriasis, including palmoplantar and nail psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: a review in moderate to severe plaque psoriasis. Garnock-Jones, KP.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38288519/

Rapid response of nail psoriasis to secukinumab in ... Conclusion: Secukinumab rapidly improved nail psoriasis after 12 weeks of treatment, with further enhancement at 24 weeks, suggesting its potential as a potent ...

2. cosentyxhcp.com cosentyxhcp.com/dermatology/pso-efficacy/nail-scalp-and-palmoplantar

Nail, Scalp, and Palmoplantar PSO Data | HCP Secukinumab shows significant efficacy in palmoplantar psoriasis: results from GESTURE, a randomized controlled trial. J Am Acad Dermatol. 2017;76(1):70-80 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32479641/

Secukinumab shows high and sustained efficacy in nail ... The effect was sustained over 2·5 years with a large benefit for nail clearance, with mean NAPSI improvement of -73·3% and -63·6% with secukinumab 300 mg and ...

4. 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 ...

5. novartis.gcs-web.com novartis.gcs-web.com/Novartis-Cosentyx-is-first-biologic-to-show-long-term-efficacy-in-nail-and-palmoplantar-psoriasis-which-can-impact-up-to-90-of-psoriasis-patients

Novartis' Cosentyx® is first biologic to show long-term efficacy ... Secukinumab Shows High and Sustained Efficacy in Nail Psoriasis: 2.5-Year Results From the TRANSFIGURE Study. Abstract presented at the 2017 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7986088/

Secukinumab demonstrates high efficacy and a favourable ... Secukinumab has demonstrated sustained long‐term efficacy with a favourable safety profile in various psoriatic disease manifestations in adults.

7. 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 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0365059624001405

Efficacy and safety of secukinumab in psoriasis: five-year ... Fifty-three (53%) of the patients were bionaive. PASI-75, -90, -100 response rates were 72%, 50%, 30% respectively at week 16 in all patients.

9. pubs.aip.org pubs.aip.org/aip/adv/article/15/1/015021/3331591/Meta-analysis-of-the-efficacy-and-safety-of

Meta-analysis of the efficacy and safety of secukinumab in ... Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study. ,”.