Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)

University of Pennsylvania16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

Secukinumab Auto-InjectorDRUG

300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 * Age 18-85 Exclusion Criteria: * History of IL-17 inhibitor use (other therapies including TNF inhibitors or non- biologics DMARDS in the past are acceptable) * Inflammatory bowel disease * Metal implants or other concerns for use of MRI * Active infection * Patients may have a history of self-reported psoriatic arthritis but may not have active PsA at the time of screening. * We will exclude patients with onychomyosis of the fingernails on clippings

Locations (1)

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

NAPSI

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.

Time frame: Baseline to 24 Weeks

Secondary Outcomes

PASI

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.

Time frame: Baseline to 24 Weeks

Physician Global Assessment of Nail Disease

Physician Global Assessment of Nail Disease. Scale of 0-100 with higher score corresponding to a worse outcome.

Time frame: Baseline to 24 Weeks

DLQI

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.

Time frame: Baseline to 24 Weeks

Data from ClinicalTrials.gov

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