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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807520


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

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