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

Phase 4

Recruiting

• Conditions: Psoriasis
• Interventions: Drug: Secukinumab Auto-Injector

• Registration Number: NCT04535999
• Lead Sponsor: University of Pennsylvania

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-02
• Study Start: 2022-02-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	Secukinumab Auto-Injector	Secukinumab

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Hospital at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States