Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

Moderate to Severe Nail Psoriasis Clinical Trial

— TRANSFIGURE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807520
• Other study ID #: CAIN457A2313
• Secondary ID: 2012-005413-40
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2013
• Last updated: February 14, 2018
• Start date: June 20, 2013
• Est. completion date: January 3, 2017

Study information

• Verified date: February 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Moderate to Severe Nail Psoriasis
• Psoriasis

Intervention

Biological:
• Secukinumab
Study treatment was provided in pre-filled 1 mL syringes.
• Placebo
Placebo was provided in pre-filled 1 mL syringes.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czechia,  Denmark,  Germany,  Greece,  Spain,  United Kingdom, 

Outcome

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