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

Primary Purpose

Psoriasis

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Secukinumab Auto-Injector
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital at the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Secukinumab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2020
Last Updated
February 9, 2023
Sponsor
University of Pennsylvania
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT04535999
Brief Title
Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)
Official Title
Phase IV Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Novartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Intervention-Secukinumab
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
Secukinumab
Intervention Type
Drug
Intervention Name(s)
Secukinumab Auto-Injector
Other Intervention Name(s)
Cosentyx
Intervention Description
300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)
Primary Outcome Measure Information:
Title
NAPSI
Description
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.
Time Frame
Baseline to 24 Weeks
Secondary Outcome Measure Information:
Title
PASI
Description
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.
Time Frame
Baseline to 24 Weeks
Title
Physician Global Assessment of Nail Disease
Description
Physician Global Assessment of Nail Disease. Scale of 0-100 with higher score corresponding to a worse outcome.
Time Frame
Baseline to 24 Weeks
Title
DLQI
Description
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.
Time Frame
Baseline to 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital at the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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