Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
NCT ID: NCT02008890
Last Updated: 2019-01-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
237 participants
INTERVENTIONAL
2013-12-26
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Secukinumab 300mg
Secukinumab 300mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 300mg at 4-weekly intervals starting Week 52 up to Week 148.
Secukinumab 300mg
Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
Placebo
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Secukinumab 150mg
Secukinumab 150mg once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 48.
In order to maintain the blinding beyond the primary endpoint, placebo was administered at Weeks 17, 18 and 19.
For extension period: Secukinumab 150mg at 4-weekly intervals starting Week 52 up to Week 148.
Secukinumab 150mg
secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
Placebo
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Placebo
Placebo once weekly at Weeks 1, 2 and 3, thereafter at 4-weekly intervals starting Week 4 until Week 12. Patients who achieved ppPASI 75 at Week 16 remained on placebo treatment Until week 48 and were not eligible to enter the extension. Patients who did not achieve ppPASI 75 at Week 16 were re-randomized to receive Secukinumab 150mg or Secukinumab 300mg from Week 16 onwards up to Week 148.
Secukinumab 300mg
Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
Secukinumab 150mg
secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
Placebo
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Interventions
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Secukinumab 300mg
Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
Secukinumab 150mg
secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
Placebo
secukinumab placebo s.c. (two PFS injections of placebo) self-administered
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by:
* ppPASI score of ≥ 12 and
* DLQI ≥ 10
* Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by:
* Topical treatment, and/or
* Phototherapy, and/or
* Previous systemic therapy
Exclusion Criteria
* Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis
* Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study
* Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to
* Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment
* Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
* Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Feldkirch, , Austria
Novartis Investigative Site
Graz, , Austria
Novartis Investigative Site
Linz, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Limoges, Haute Vienne, France
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Clermont-Ferrand, , France
Novartis Investigative Site
Martigues, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Paris, , France
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Paris, , France
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Poitiers, , France
Novartis Investigative Site
Rouen, , France
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Toulouse, , France
Novartis Investigative Site
Berlin, , Germany
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Bochum, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Freiburg im Breisgau, , Germany
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Gera, , Germany
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Göttingen, , Germany
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Greifswald, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanau, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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Mahlow, , Germany
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Münster, , Germany
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Plauen, , Germany
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Recklinghausen, , Germany
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Schwerin, , Germany
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Bydgoszcz, , Poland
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Olsztyn, , Poland
Novartis Investigative Site
Zabrze, , Poland
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Moscow, , Russia
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Rostov on Don Region, , Russia
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Ryazan, , Russia
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Saratov, , Russia
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
A Coruña, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
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Madrid, , Spain
Novartis Investigative Site
Gothenburg, Västra Götaland County, Sweden
Novartis Investigative Site
Jönköping, , Sweden
Novartis Investigative Site
Malmo, , Sweden
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
Uppsala, , Sweden
Novartis Investigative Site
Leytonstone, London, United Kingdom
Novartis Investigative Site
Salford, Manchester, United Kingdom
Novartis Investigative Site
Dundee, Perthshire, United Kingdom
Novartis Investigative Site
Dudley, West Midlands, United Kingdom
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
Newport, , United Kingdom
Novartis Investigative Site
Portsmouth, , United Kingdom
Novartis Investigative Site
Wolverhampton, , United Kingdom
Novartis Investigative Site
York, , United Kingdom
Countries
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Other Identifiers
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2013-003086-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A3301
Identifier Type: -
Identifier Source: org_study_id
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