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Completed

NCT Number: NCT04535999

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Secukinumab Auto-Injector

Drug

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

Other names: Cosentyx

Primary outcomes

  1. NAPSI

    Time frame: 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 outcomes

  1. PASI

    Time frame: 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.

  2. Physician Global Assessment of Nail Disease

    Time frame: Baseline to 24 Weeks

    Physician Global Assessment of Nail Disease. Scale of 0-100 with higher score corresponding to a worse outcome.

  3. DLQI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 2, 2020
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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