Clinical trial
Phase IV Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis
Name
834149
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. We will examine time to response and different methods of defining nail disease response.
Trial arms
Trial start
2022-02-07
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Secukinumab Auto-Injector
300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)
Arms:
Open Label
Other names:
Cosentyx
Size
40
Primary endpoint
NAPSI
Baseline to 24 Weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intervention-Secukinumab', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-02-20
1 organization
1 product
1 indication
Organization
University of PennsylvaniaProduct
SecukinumabIndication
Psoriasis