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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Secukinumab Auto-Injector

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sarah Gillespie, MS; Phone Number: 2156141840; Email: sarah.hopkins@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital at the University of Pennsylvania
      • Principal Investigator: Alexis Ogdie-Beatty, MD, MSCE
      • Contact: Sarah Gillespie, MS; Phone Number: 215-614-1840; Email: sarah.hopkins@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Cosentyx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 24 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to 24 Weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Novartis
• Investigators: Principal Investigator: Alexis Ogdie-Beatty, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 834149

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No