Moderate to Severe Nail Psoriasis Clinical Trial
— TRANSFIGUREOfficial title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Nail Psoriasis
| Verified date | February 2018 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 198 |
| Est. completion date | January 3, 2017 |
| Est. primary completion date | January 3, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 ß-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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | East Melbourne | Victoria |
| Australia | Novartis Investigative Site | Sydney | New South Wales |
| Australia | Novartis Investigative Site | Woolloongabba | Queensland |
| Belgium | Novartis Investigative Site | Bruxelles | |
| Belgium | Novartis Investigative Site | Liege | |
| Czechia | Novartis Investigative Site | Prague 10 | |
| Czechia | Novartis Investigative Site | Usti nad Labem | Czech Republic |
| Denmark | Novartis Investigative Site | Arhus C | |
| Denmark | Novartis Investigative Site | Copenhagen NV | |
| Denmark | Novartis Investigative Site | Hellerup | |
| Germany | Novartis Investigative Site | Bad Bentheim | |
| Germany | Novartis Investigative Site | Bielefeld | |
| Germany | Novartis Investigative Site | Hamburg | |
| Germany | Novartis Investigative Site | Kiel | |
| Germany | Novartis Investigative Site | Muenster | |
| Greece | Novartis Investigative Site | Athens | |
| Greece | Novartis Investigative Site | Heraklion, Crete | GR |
| Spain | Novartis Investigative Site | Baracaldo | Vizcaya |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Sabadell | Barcelona |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| United Kingdom | Novartis Investigative Site | Birmingham | |
| United Kingdom | Novartis Investigative Site | Dudley | West Midlands |
| United Kingdom | Novartis Investigative Site | Liverpool | |
| United Kingdom | Novartis Investigative Site | London | England |
| United Kingdom | Novartis Investigative Site | Newcastle upon Tyne | |
| United Kingdom | Novartis Investigative Site | Staffordshire | |
| United States | Novartis Investigative Site | Birmingham | Alabama |
| United States | Novartis Investigative Site | Duncansville | Pennsylvania |
| United States | Novartis Investigative Site | High Point | North Carolina |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis Investigative Site | Indianapolis | Indiana |
| United States | Novartis Investigative Site | Nashville | Tennessee |
| United States | Novartis Investigative Site | Phoenix | Arizona |
| United States | Novartis Investigative Site | Portland | Oregon |
| United States | Novartis Investigative Site | Skokie | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Belgium, Czechia, Denmark, Germany, Greece, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment | The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented. | Baseline, 16 weeks | |
| Secondary | Percent Change From Baseline in NAPSI Score | The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. | baseline, 16 weeks, 132 weeks | |
| Secondary | Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132 | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline. | 16 weeks, 132 weeks | |
| Secondary | Number of Participants Who Develop Immunogenicity Against Secukinumab | The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive. | Week 132 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03897075 -
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
|
Phase 3 |