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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response.

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 data supports the effectiveness of the drug Secukinumab for treating nail psoriasis?

Secukinumab has shown significant effectiveness in treating nail psoriasis, with studies reporting a reduction in nail disease severity by 80% at 12 weeks. It is also effective in improving symptoms of psoriatic arthritis and skin psoriasis, making it a strong option for patients with these conditions. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Secukinumab for nail psoriasis?

Secukinumab has shown significant effectiveness in treating nail psoriasis, with studies reporting a reduction in nail disease severity by 80% at 12 weeks. It is also effective in treating skin symptoms and is well tolerated, making it a promising option for patients with nail psoriasis. ^{1 2 3 4 5}

Is secukinumab safe for treating nail psoriasis?

Secukinumab, also known as Cosentyx or AIN457, has been shown to be generally safe in humans, with common mild side effects like upper respiratory infections and headaches. It has been tested in various conditions, including psoriasis and psoriatic arthritis, with a favorable short-term safety profile. ^{1 2 3 6 7}

Is secukinumab safe for treating nail psoriasis?

Secukinumab, also known as Cosentyx or AIN457, has been shown to be generally safe in humans, with common mild side effects like upper respiratory infections and headaches. It has been tested in various conditions, including psoriasis and psoriatic arthritis, with a favorable short-term safety profile. ^{1 2 3 6 7}

What makes the drug Secukinumab unique for treating nail psoriasis?

Secukinumab is unique because it is a fully human monoclonal antibody that targets interleukin-17A, a protein involved in inflammation, and is administered through injections. It has shown significant and sustained improvement in nail psoriasis, even in patients who do not respond well to other systemic therapies. ^{1 2 3 8 9}

How is the drug Secukinumab unique for treating nail psoriasis?

Secukinumab is unique because it is a fully human monoclonal antibody that targets interleukin-17A, a key player in psoriasis, and is effective in treating both skin and nail psoriasis, which are often difficult to manage. It is administered subcutaneously (under the skin) and has shown significant improvement in nail psoriasis symptoms, even in patients who do not respond well to other systemic therapies. ^{1 2 3 5 8}

Research Team

Alexis Ogdie-Beatty, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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 am between 18 and 85 years old.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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, 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Secukinumab efficacy in the treatment of nail psoriasis: a case series. [2019]

2. Italy 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. [2022]

3. England 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. [2022]

4. Sweden pubmed.ncbi.nlm.nih.gov

Nail Psoriasis: An Updated Review and Expert Opinion on Available Treatments, Including Biologics. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Secukinumab: a review in moderate to severe plaque psoriasis. [2019]

6. Canada pubmed.ncbi.nlm.nih.gov

Secukinumab in the Treatment of Psoriasis and Psoriatic Arthritis: A Review of the Literature. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Secukinumab: first global approval. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Secukinumab for the treatment of psoriatic arthritis. [2019]