Status:
COMPLETED
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Moderate to Severe Nail Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.
Eligibility Criteria
Inclusion
- Subjects with chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement, defined as Nail Psoriasis Severity Index (NAPSI) score ≥16 AND number of fingernails involved ≥4 AND Psoriasis Area and Severity Index (PASI) score ≥12 AND Body Surface Area (BSA) score ≥10%
- Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy
Exclusion
- Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
- Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
- Ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects
- Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply
- Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
- Exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
- History of hypersensitivity to constituents of the study treatment
- Other protocol-defined inclusion/exclusion criteria do apply
Key Trial Info
Start Date :
June 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2017
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01807520
Start Date
June 20 2013
End Date
January 3 2017
Last Update
March 13 2018
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Birmingham, Alabama, United States, 35233
2
Novartis Investigative Site
Phoenix, Arizona, United States, 85032
3
Novartis Investigative Site
Skokie, Illinois, United States, 60077
4
Novartis Investigative Site
Indianapolis, Indiana, United States, 46256