Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)
Phase IV Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedStudy Start
First participant enrolled
February 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedJuly 18, 2025
July 1, 2025
3.3 years
August 27, 2020
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
PASI
Baseline to 24 Weeks
Physician Global Assessment of Nail Disease
Baseline to 24 Weeks
DLQI
Baseline to 24 Weeks
Study Arms (1)
Open Label
EXPERIMENTALSecukinumab
Interventions
300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Novartiscollaborator
Study Sites (1)
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexis Ogdie-Beatty, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2020
First Posted
September 2, 2020
Study Start
February 7, 2022
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
July 18, 2025
Record last verified: 2025-07