Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. This is a single arm trial - all patients will receive the study drug. We will examine time to response and different methods of defining nail disease response.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open Label Secukinumab |
Drug: Secukinumab Auto-Injector
300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)
Other Names:
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Outcome Measures
Primary Outcome Measures
- NAPSI [Baseline to 24 Weeks]
Nail Psoriasis Severity Index (NAPSI): NAPSI is the most comprehensive nail assessment used in clinical trials. The fingernail is divided into four quadrants. For each quadrant, 1 point is assigned for a nail matrix abnormality and 1 point for a nail bed abnormality allowing for a total of 8 points per nail. 0-80 total points possible with a higher score corresponding to a worse outcome.
Secondary Outcome Measures
- PASI [Baseline to 24 Weeks]
Psoriasis Area Severity Index (PASI): Four assessments for each of four body areas (head, trunk, upper extremities, and lower extremities) are provided. The assessments are erythema, induration, and scale (each assessed as 0-4 using a standardized scale), and the number of palms/percentage of each area is categorized (0 = 0%, 1 = less than 10%, 2 = 10%-29%, 3 = 30%-40%, 4 = 50%-69%, 5 = 70%-89%, and 6 = 90%-100%). The scale is 0 to 72 with a higher score corresponding to a worse outcome.
- Physician Global Assessment of Nail Disease [Baseline to 24 Weeks]
Physician Global Assessment of Nail Disease. Scale of 0-100 with higher score corresponding to a worse outcome.
- DLQI [Baseline to 24 Weeks]
Dermatology Life Quality Index (DLQI): There are a total of 10 questions and each question is scored on a four-point Likert scale: Very much = 3 A lot = 2 A little = 1 Not at all = 0 Not relevant = 0 Question unanswered = 0 The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Active psoriatic nail disease defined as a Minimum 4 or more fingernails OR NAPSI>20
-
Active skin psoriasis currently (no minimum PASI or BSA) or skin psoriasis in the past documented by a dermatologist
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Age 18-85
Exclusion Criteria:
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History of IL-17 inhibitor use (other therapies including TNF inhibitors or non- biologics DMARDS in the past are acceptable)
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Inflammatory bowel disease
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Metal implants or other concerns for use of MRI
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Active infection
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Patients may have a history of self-reported psoriatic arthritis but may not have active PsA at the time of screening.
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We will exclude patients with onychomyosis of the fingernails on clippings
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital at the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
- Novartis
Investigators
- Principal Investigator: Alexis Ogdie-Beatty, MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 834149