Secukinumab for Nail Psoriasis

Recruiting in Palo Alto (17 mi)

Overseen by Alexis Ogdie-Beatty, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Pennsylvania

Must not be taking: IL-17 inhibitors

Disqualifiers: Inflammatory bowel disease, Active infection, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

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.

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}

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}

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.

Treatment Details

Interventions

• Secukinumab (Monoclonal Antibodies)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hospital at the University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2118

Patients Recruited

45,270,000+

Novartis

Industry Sponsor

Trials

1646

Patients Recruited

2,778,000+

Findings from Research

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]