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

• ClinicalTrials.gov Identifier: NCT01807520
• Recruitment Status: Completed
• First Posted: March 8, 2013
• Results First Posted: March 13, 2018
• Last Update Posted: March 13, 2018
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Moderate to Severe Nail Psoriasis	Biological: Secukinumab; Biological: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 20, 2013
• Actual Primary Completion Date: January 3, 2017
• Actual Study Completion Date: January 3, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Secukinumab (AIN457) 150 mg; Participants assigned to secukinumab 150 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.	Biological: Secukinumab; Study treatment was provided in pre-filled 1 mL syringes.; Other Name: AIN457
Experimental: Secukinumab (AIN457) 300 mg; Participants assigned to secukinumab 300 mg were dosed weekly for five weeks, then once every four weeks up to and including Week 132. To maintain the blinding, patients received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment are administered by sub-cutaneous injections.	Biological: Secukinumab; Study treatment was provided in pre-filled 1 mL syringes.; Other Name: AIN457
Placebo Comparator: Placebo; Patients assigned to placebo were dosed weekly for five weeks, then at Week 8 and Week 12. At Week 16, placebo patients were randomized in a 1:1 ratio, to receive secukinumab either 150 mg or 300 mg and were dosed weekly for five weeks starting at Week 16, then once every four weeks up to and including Week 132. All doses of study treatment are administered by sub-cutaneous injections.	Biological: Placebo; Placebo was provided in pre-filled 1 mL syringes.; Other Name: placebo secukinumab

Outcome Measures

Primary Outcome Measures :

1. Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment [ Time Frame: Baseline, 16 weeks ]
   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.

Secondary Outcome Measures :

1. Percent Change From Baseline in NAPSI Score [ Time Frame: baseline, 16 weeks, 132 weeks ]
   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.
2. 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 [ Time Frame: 16 weeks, 132 weeks ]
   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.
3. Number of Participants Who Develop Immunogenicity Against Secukinumab [ Time Frame: Week 132 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 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

Contacts and Locations

Locations

United States, Alabama

Novartis Investigative Site

Birmingham, Alabama, United States, 35233

United States, Arizona

Novartis Investigative Site

Phoenix, Arizona, United States, 85032

United States, Illinois

Novartis Investigative Site

Skokie, Illinois, United States, 60077

United States, Indiana

Novartis Investigative Site

Indianapolis, Indiana, United States, 46256

United States, North Carolina

Novartis Investigative Site

High Point, North Carolina, United States, 27262

United States, Oregon

Novartis Investigative Site

Portland, Oregon, United States, 97210

United States, Pennsylvania

Novartis Investigative Site

Duncansville, Pennsylvania, United States, 16635

United States, Tennessee

Novartis Investigative Site

Nashville, Tennessee, United States, 37203

United States, Texas

Novartis Investigative Site

Houston, Texas, United States, 77030

Australia, New South Wales

Novartis Investigative Site

Sydney, New South Wales, Australia, 2010

Australia, Queensland

Novartis Investigative Site

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Novartis Investigative Site

East Melbourne, Victoria, Australia, 3002

Belgium

Novartis Investigative Site

Bruxelles, Belgium, 1200

Novartis Investigative Site

Liege, Belgium, 4000

Czechia

Novartis Investigative Site

Usti nad Labem, Czech Republic, Czechia, 400 11

Novartis Investigative Site

Prague 10, Czechia, 100 34

Denmark

Novartis Investigative Site

Arhus C, Denmark, DK-8000

Novartis Investigative Site

Copenhagen NV, Denmark, DK-2400

Novartis Investigative Site

Hellerup, Denmark, DK-2900

Germany

Novartis Investigative Site

Bad Bentheim, Germany, 48455

Novartis Investigative Site

Bielefeld, Germany, 33647

Novartis Investigative Site

Hamburg, Germany, 20354

Novartis Investigative Site

Kiel, Germany, 24105

Novartis Investigative Site

Muenster, Germany, 48143

Greece

Novartis Investigative Site

Heraklion, Crete, GR, Greece, 71110

Novartis Investigative Site

Athens, Greece, 161 21

Spain

Novartis Investigative Site

Sabadell, Barcelona, Spain, 08208

Novartis Investigative Site

Barcelona, Catalunya, Spain, 08003

Novartis Investigative Site

Valencia, Comunidad Valenciana, Spain, 46017

Novartis Investigative Site

Baracaldo, Vizcaya, Spain, 48903

Novartis Investigative Site

Madrid, Spain, 28006

Novartis Investigative Site

Madrid, Spain, 28031

Novartis Investigative Site

Madrid, Spain, 28041

Novartis Investigative Site

Madrid, Spain, 28046

United Kingdom

Novartis Investigative Site

London, England, United Kingdom, E11 1NR

Novartis Investigative Site

Dudley, West Midlands, United Kingdom, DY1 2HQ

Novartis Investigative Site

Birmingham, United Kingdom, B15 2TH

Novartis Investigative Site

Liverpool, United Kingdom, L14 3PE

Novartis Investigative Site

Newcastle upon Tyne, United Kingdom, NE1 4LP

Novartis Investigative Site

Staffordshire, United Kingdom, WS11 5XY

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01807520
• Other Study ID Numbers: CAIN457A2313; 2012-005413-40 ( EudraCT Number )
• First Posted: March 8, 2013
• Results First Posted: March 13, 2018
• Last Update Posted: March 13, 2018
• Last Verified: February 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Moderate nail psoriasis; Severe nail psoriasis; psoriasis; Secukinumab

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs