Moderate to Severe Palmoplantar PsoriasisPhase 3GESTURENCT01806597
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
A Phase 3 study testing secukinumab 150 mg and secukinumab 300 mg in people with Moderate to Severe Palmoplantar Psoriasis, run by Novartis Pharmaceuticals at 54 sites in 15 countries.
Trial summary
Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the 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 Palmoplantar Psoriasis
- What is being tested?
- secukinumab 150 mg and secukinumab 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 54 sitesin 15 countries
- Study dates
- 19 Jun 2013to 2 Nov 2016
- 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 and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area
- 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 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
- Use of 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
- Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
- History of hypersensitivity to constituents of the study treatment
Trial locations and contacts
54 sites in 15 countries.
54 sites in 15 countries
United States8 sites
Novartis Investigative Site
Birmingham, Alabama, 35205
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Goodlettsville, Tennessee, 37072-2301
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Louisville, Kentucky, 40291
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Verona, New Jersey, 07044
Canada5 sites
Novartis Investigative Site
Barrie, Ontario, L4M 6L2
Novartis Investigative Site
Calgary, Alberta, T2S 3B3
Novartis Investigative Site
London, Ontario, N6A 3H7
Novartis Investigative Site
Montreal, Quebec, H3Z 2S6
Novartis Investigative Site
Waterloo, Ontario, N2J 1C4
Portugal5 sites
Novartis Investigative Site
Coimbra, 3000-075
Novartis Investigative Site
Lisbon, 1649-035
Novartis Investigative Site
Lisbon, 1998 - 018
Novartis Investigative Site
Porto, 4099-001
Novartis Investigative Site
Porto, 4200 319
Australia4 sites
Novartis Investigative Site
Carlton, Victoria, 3053
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Sydney, New South Wales, 2010
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Hungary4 sites
Novartis Investigative Site
Budapest, 1134
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Miskolc, 3529
Novartis Investigative Site
Szeged, H-6725
Israel4 sites
Novartis Investigative Site
Afula, 1834111
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Tel Aviv, 6209804
Novartis Investigative Site
Tel Aviv, 64239
Russia4 sites
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 107076
Novartis Investigative Site
Moscow, 119071
Novartis Investigative Site
Saint Petersburg, 194044
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, 06500
Novartis Investigative Site
Fatih / Istanbul, Turkey, 34093
Novartis Investigative Site
Gaziantep, 27310
Novartis Investigative Site
Istanbul, TUR, 34098
Netherlands3 sites
Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Breda, CK, 4818
Novartis Investigative Site
Rotterdam, 3015 CE
Slovakia3 sites
Novartis Investigative Site
Košice, 04011
Novartis Investigative Site
Kosice-Saca, Slovak Republic, 040 15
Novartis Investigative Site
Svidník, 089 01
Spain3 sites
Novartis Investigative Site
Badalona, Catalonia, 08916
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de G.C, 35010
Belgium2 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Liège, 4000
Finland2 sites
Novartis Investigative Site
Helsinki, 00250 HUS
Novartis Investigative Site
Tampere, 33100
United Kingdom2 sites
Novartis Investigative Site
Dudley, West Midlands, DY1 2HQ
Novartis Investigative Site
London, England, E11 1NR
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 Palmoplantar Psoriasis
Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.
- Being tested
- secukinumab 150 mg, secukinumab 300 mg, Placebo
- Keywords
- Skin condition, itching, psoriasis vulgaris, relapsing remitting psoriasis, immune-med systemic disease, skin lesions, scaly patches, papules, plaques
- Medical subject headings
- Skin Diseases, Pruritus, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secukinumab 150 mgBiological
Also called AIN457 150 mg
Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
secukinumab 300 mgBiological
Also called AIN457 300 mg
Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
PlaceboBiological
Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
| Study group | Role | What they receive |
|---|---|---|
| secukinumab 150mg | Experimental | 201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 150 mg were dosed weekly for the first five weeks, then every four weeks up to and including Week 128. To maintain blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. Receives: Biological: secukinumab 150 mg |
| secukinumab 300 mg | Experimental | 201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 300 mg were dosed weekly for the first five weeks and then every four weeks up to and including Week 128. In order to maintain the blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. Receives: Biological: secukinumab 300 mg |
| Placebo | Placebo comparator | 201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects on placebo were dosed weekly for 5 weeks then once every 4 weeks. At Week 16, ppIGA responders continued to receive placebo weekly for 5 weeks starting at Week 16, then every 4 weeks up to and including Week 76 while ppIGA non-responders were randomized in a 1:1 ratio to secukinumab either 150 mg or 300mg weekly for 5 weeks, starting at Week 16, then every 4 weeks up to and including Week 128. At Week 80, subjects on placebo were either terminated their participation, if ppIGA responders, or randomized in a 1:1 ratio to secukinumab either 150 mg or 300 mg once every 4 weeks until Week 128 inclusive. All doses of study treatment were 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.
Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment
palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
Measured: Week 16
Secondary outcomes (6)
Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I
ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
Measured: Week 1, week 2, week 4, week, 8, week 12, week 16
Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II
ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
Measured: Week 16, Week 20, Week 28, Week 32, Week 64, Week 132
Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period
ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.
Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline).
Measured: Week 16, Week 24, Week 28, Week 80
Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Measured: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set
Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).
Measured: Week 16, Week 32, Week 80, Week 132
Number of Participants Developing Anti-secukinumab Antibodies
To investigate the development of immunogenicity against secukinumab
Measured: Over time up to week 132
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study start19 Jun 2013
- Primary completion2 Nov 2016
- Study completion2 Nov 2016
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 Palmoplantar 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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806597
- Sponsor's protocol ID
- CAIN457A2312
- Other IDs
- 2012-005412-25
- Acronym
- GESTURE
- Status last verified
- Jan 2018
- First submitted
- 23 Jan 2013
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 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 Palmoplantar Psoriasis
- ClinicalTrials.gov ID
- NCT01806597
- Acronym / sponsor ID
- GESTURE / CAIN457A2312
- Keywords
- Skin condition, itching, psoriasis vulgaris, relapsing remitting psoriasis, immune-med systemic disease, skin lesions, scaly patches, papules, plaques
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2013 (actual)
- Primary completion
- 2 Nov 2016 (actual)
- Study completion
- 2 Nov 2016 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the 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 150mg | Experimental | Biological: secukinumab 150 mg201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 150 mg were dosed weekly for the first five weeks, then every four weeks up to and including Week 128. To maintain blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. |
| secukinumab 300 mg | Experimental | Biological: secukinumab 300 mg201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects assigned to secukinumab 300 mg were dosed weekly for the first five weeks and then every four weeks up to and including Week 128. In order to maintain the blinding, subjects received additional placebo injections at Weeks 17, 18 and 19. All doses of study treatment were administered by sub-cutaneous injections. |
| Placebo | Placebo comparator | Biological: Placebo201 subjects were randomized in a 1:1:1 ratio to secukinumab either 150 mg or 300 mg, or placebo. Subjects on placebo were dosed weekly for 5 weeks then once every 4 weeks. At Week 16, ppIGA responders continued to receive placebo weekly for 5 weeks starting at Week 16, then every 4 weeks up to and including Week 76 while ppIGA non-responders were randomized in a 1:1 ratio to secukinumab either 150 mg or 300mg weekly for 5 weeks, starting at Week 16, then every 4 weeks up to and including Week 128. At Week 80, subjects on placebo were either terminated their participation, if ppIGA responders, or randomized in a 1:1 ratio to secukinumab either 150 mg or 300 mg once every 4 weeks until Week 128 inclusive. All doses of study treatment were 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 and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area
- 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 (7 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 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
- Use of 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
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 |
|---|---|---|
| secukinumab 150 mgAlso: AIN457 150 mgStudy treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise. | Biological | secukinumab 150mg |
| secukinumab 300 mgAlso: AIN457 300 mgStudy treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise. | Biological | secukinumab 300 mg |
| PlaceboPlacebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise. | Biological | Placebo |
Primary outcome
Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment
Time frame: Week 16
palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.
6 secondary outcomes
Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I
Time frame: Week 1, week 2, week 4, week, 8, week 12, week 16
Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II
Time frame: Week 16, Week 20, Week 28, Week 32, Week 64, Week 132
Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period
Time frame: Week 16, Week 24, Week 28, Week 80
Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I
Time frame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set
Time frame: Week 16, Week 32, Week 80, Week 132
Number of Participants Developing Anti-secukinumab Antibodies
Time frame: Over time up to week 132
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
54 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing secukinumab 150 mg and secukinumab 300 mg in people with Moderate to Severe Palmoplantar Psoriasis, run by Novartis Pharmaceuticals at 54 sites in 15 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 7 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada, Portugal, Australia, Hungary and 10 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 22 Feb 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?
Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.