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Monoclonal Antibodies

Secukinumab for Nail Psoriasis

Phase 4
Recruiting
Led By Alexis Ogdie-Beatty, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-85
Active psoriatic nail disease defined as a Minimum 4 or more fingernails OR NAPSI>20
Must not have
Patients with onychomyosis of the fingernails on clippings will be excluded
Inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial will study the effectiveness of secukinumab, an FDA-approved drug, in treating nail psoriasis.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Secukinumab may cause side effects like cold symptoms, diarrhea, upper respiratory infections, hives at injection site. Since it affects the immune system, there might be an increased risk of other infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old.
Select...
I have psoriasis affecting 4 or more of my fingernails.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a fungal nail infection on my fingernails.
Select...
I have inflammatory bowel disease.
Select...
I currently have an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
NAPSI
Secondary study objectives
DLQI
PASI
Physician Global Assessment of Nail Disease

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Secukinumab

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,727,008 Total Patients Enrolled
11 Trials studying Psoriasis
2,758 Patients Enrolled for Psoriasis
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,263 Total Patients Enrolled
8 Trials studying Psoriasis
4,001 Patients Enrolled for Psoriasis
Alexis Ogdie-Beatty, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
487 Total Patients Enrolled
1 Trials studying Psoriasis
100 Patients Enrolled for Psoriasis

Media Library

Secukinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04535999 — Phase 4
Psoriasis Research Study Groups: Open Label
Psoriasis Clinical Trial 2023: Secukinumab Highlights & Side Effects. Trial Name: NCT04535999 — Phase 4
Secukinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535999 — Phase 4
~10 spots leftby Dec 2025
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