Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01807520
Registration number
NCT01807520
Ethics application status
Date submitted
23/01/2013
Date registered
8/03/2013
Date last updated
13/03/2018
Titles & IDs
Public title
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2012-005413-40
Query!
Secondary ID [2]
0
0
CAIN457A2313
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
TRANSFIGURE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Nail Psoriasis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Secukinumab
Other interventions - Placebo
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.
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.
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.
Other interventions: Secukinumab
Study treatment was provided in pre-filled 1 mL syringes.
Other interventions: Placebo
Placebo was provided in pre-filled 1 mL syringes.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, 16 weeks
Query!
Secondary outcome [1]
0
0
Percent Change From Baseline in NAPSI Score
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
baseline, 16 weeks, 132 weeks
Query!
Secondary outcome [2]
0
0
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
16 weeks, 132 weeks
Query!
Secondary outcome [3]
0
0
Number of Participants Who Develop Immunogenicity Against Secukinumab
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Week 132
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/06/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
3/01/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
198
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Sydney
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
3002 - East Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
North Carolina
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Oregon
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Tennessee
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Bruxelles
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Liege
Query!
Country [12]
0
0
Czechia
Query!
State/province [12]
0
0
Czech Republic
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Prague 10
Query!
Country [14]
0
0
Denmark
Query!
State/province [14]
0
0
Arhus C
Query!
Country [15]
0
0
Denmark
Query!
State/province [15]
0
0
Copenhagen NV
Query!
Country [16]
0
0
Denmark
Query!
State/province [16]
0
0
Hellerup
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Bad Bentheim
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Bielefeld
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Hamburg
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Kiel
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Muenster
Query!
Country [22]
0
0
Greece
Query!
State/province [22]
0
0
GR
Query!
Country [23]
0
0
Greece
Query!
State/province [23]
0
0
Athens
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Barcelona
Query!
Country [25]
0
0
Spain
Query!
State/province [25]
0
0
Catalunya
Query!
Country [26]
0
0
Spain
Query!
State/province [26]
0
0
Comunidad Valenciana
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Vizcaya
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Madrid
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
England
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
West Midlands
Query!
Country [31]
0
0
United Kingdom
Query!
State/province [31]
0
0
Birmingham
Query!
Country [32]
0
0
United Kingdom
Query!
State/province [32]
0
0
Liverpool
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
Newcastle upon Tyne
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
Staffordshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01807520
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01807520
Download to PDF