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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04535999
• Other study ID #: 834149
• Status: Recruiting
• Phase: Phase 4
• Start date: February 7, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Sarah Gillespie, MS
• Phone: 2156141840
• Email: sarah.hopkins[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Secukinumab Auto-Injector
300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)

Locations

Country	Name	City	State
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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