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

University of Pennsylvania

Status and phase: Enrolling; Phase 4

Conditions: Psoriasis

Treatments: Drug: Secukinumab Auto-Injector

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04535999

834149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Open Label

Experimental group

Description:

Secukinumab

Treatment:

Drug: Secukinumab Auto-Injector