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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
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
2,075 Previous Clinical Trials
42,719,806 Total Patients Enrolled
11 Trials studying Psoriasis
2,758 Patients Enrolled for Psoriasis
NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,553 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
Eligibility Criteria:
This trial includes the following eligibility 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 have or had skin psoriasis diagnosed by a dermatologist.I am between 18 and 85 years old.I do not have a fungal nail infection on my fingernails.I have psoriasis affecting 4 or more of my fingernails.I have inflammatory bowel disease.I currently have an infection.You have metal implants or other issues that make it unsafe for you to have an MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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