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

NCT ID: NCT04535999

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2025-05-30

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Label

Secukinumab

Group Type: EXPERIMENTAL

Secukinumab Auto-Injector

Intervention Type: DRUG

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

Interventions

Secukinumab Auto-Injector

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

Intervention Type: DRUG

Other Intervention Names

Cosentyx

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexis Ogdie-Beatty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

834149

Identifier Type: -

Identifier Source: org_study_id