Moderate to Severe Nail PsoriasisPhase 3TRANSFIGURENCT01807520

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

A Phase 3 study testing Secukinumab in people with Moderate to Severe Nail Psoriasis, run by Novartis Pharmaceuticals at 40 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Moderate to Severe Nail Psoriasis
What is being tested?: Secukinumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 198 participants
Where: 40 sitesin 9 countries
Study dates: 20 Jun 2013to 3 Jan 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

40 sites in 9 countries.

Country

City, postcode or hospital

40 sites in 9 countries

United States9 sites

Novartis Investigative Site
Birmingham, Alabama, 35233
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Skokie, Illinois, 60077

Other trials in United States

Spain8 sites

Novartis Investigative Site
Barakaldo, Vizcaya, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28031
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
Valencia, Valencia, 46017

Other trials in Spain

United Kingdom6 sites

Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
Liverpool, L14 3PE
Novartis Investigative Site
London, England, E11 1NR
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
Novartis Investigative Site
Staffordshire, Staffordshire, WS11 5XY

Other trials in United Kingdom

Germany5 sites

Novartis Investigative Site
Bad Bentheim, 48455
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Münster, 48143

Other trials in Germany

Australia3 sites

Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Sydney, New South Wales, 2010
Novartis Investigative Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Denmark3 sites

Novartis Investigative Site
Arhus C, DK-8000
Novartis Investigative Site
Copenhagen NV, DK-2400
Novartis Investigative Site
Hellerup, DK-2900

Other trials in Denmark

Belgium2 sites

Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Liège, 4000

Other trials in Belgium

Czechia2 sites

Novartis Investigative Site
Prague, 100 34
Novartis Investigative Site
Ústí nad Labem, Czech Republic, 400 11

Other trials in Czechia

Greece2 sites

Novartis Investigative Site
Athens, 161 21
Novartis Investigative Site
Heraklion, Crete, GR, 71110

Other trials in Greece

About this study

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

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.

Conditions: Moderate to Severe Nail Psoriasis
Being tested: Secukinumab, Placebo
Keywords: Moderate nail psoriasis, Severe nail psoriasis, psoriasis, Secukinumab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SecukinumabBiological
Also called AIN457
Study treatment was provided in pre-filled 1 mL syringes.
PlaceboBiological
Also called placebo secukinumab
Placebo was provided in pre-filled 1 mL syringes.

Study groups in NCT01807520
Study group	Role	What they receive
Secukinumab (AIN457) 150 mg	Experimental	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. Receives: Biological: Secukinumab
Secukinumab (AIN457) 300 mg	Experimental	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. Receives: Biological: Secukinumab
Placebo	Placebo comparator	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. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 16 weeks

Secondary outcomes (3)

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.
Measured: baseline, 16 weeks, 132 weeks
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.
Measured: 16 weeks, 132 weeks
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.
Measured: Week 132

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 20133 Jan 2017

First posted8 Mar 2013 (estimated)
Study start20 Jun 2013
Primary completion3 Jan 2017
Study completion3 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Moderate to Severe Nail PsoriasisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01807520
Sponsor's protocol ID: CAIN457A2313
Other IDs: 2012-005413-40
Acronym: TRANSFIGURE
Status last verified: Feb 2018
First submitted: 23 Jan 2013
Last updated: 13 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01807520
Acronym / sponsor ID: TRANSFIGURE / CAIN457A2313
Conditions: Moderate to Severe Nail Psoriasis
Keywords: Moderate nail psoriasis, Severe nail psoriasis, psoriasis, Secukinumab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 Jun 2013 (actual)
Primary completion: 3 Jan 2017 (actual)
Study completion: 3 Jan 2017 (actual)
First posted: 8 Mar 2013 (estimated)
Results: Posted 13 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Secukinumab (AIN457) 150 mg	Experimental	Biological: SecukinumabParticipants 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.
Secukinumab (AIN457) 300 mg	Experimental	Biological: SecukinumabParticipants 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	Placebo comparator	Biological: PlaceboPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SecukinumabAlso: AIN457Study treatment was provided in pre-filled 1 mL syringes.	Biological	Secukinumab (AIN457) 150 mg, Secukinumab (AIN457) 300 mg
PlaceboAlso: placebo secukinumabPlacebo was provided in pre-filled 1 mL syringes.	Biological	Placebo

Primary outcome

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.

3 secondary outcomes

Percent Change From Baseline in NAPSI Score
Time frame: baseline, 16 weeks, 132 weeks
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
Number of Participants Who Develop Immunogenicity Against Secukinumab
Time frame: Week 132

Results and safety

Results posted to the registry on 13 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIN457 150 mg	67	63
AIN457 300 mg	66	65
Placebo	65	58
Placebo - AIN457 150 mg	0	0
Placebo - AIN457 300 mg	0	0
Any AIN457 150 mg	0	0
Any AIN457 300 mg	0	0

Primary outcome: Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment

Time frame: Baseline, 16 weeks. Mean (Standard Error). Unit: percent change

Measure	AIN457 150 mg n = 63	AIN457 300 mg n = 64	Placebo n = 56
Value	-38.4 (4.54)	-46.1 (3.43)	-11.7 (4.28)

AIN457 150 mg vs Placebo: Mean Difference (Net): -26.7 (95% CI -39.1 to -14.3), p <0.0001, Mixed model reapeated measures
AIN457 300 mg vs Placebo: Mean Difference (Net): -34.4 (95% CI -45.2 to -23.5), p <0.0001, Mixed model repeated measures

Population analysed: Only participants from the full analysis set (FAS) who had values at both baseline and week 16, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to week 140. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Any AIN457 150 mg	10 of 96 (10.4%)	76 of 96 (79.2%)	Not reported
Any AIN457 300 mg	9 of 94 (9.6%)	79 of 94 (84%)	Not reported
Placebo	1 of 65 (1.5%)	37 of 65 (56.9%)	Not reported
Any AIN457 Dose	19 of 190 (10%)	155 of 190 (81.6%)	Not reported

Limitations and caveats (from the sponsor): The overall study completed. However, in Spain, the study terminated early in accordance with study protocol amendment 1.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

40 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab in people with Moderate to Severe Nail Psoriasis, run by Novartis Pharmaceuticals at 40 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, United Kingdom, Germany, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment (time frame: Baseline, 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01807520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.