Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis
NCT ID: NCT01807520
Last Updated: 2018-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2013-06-20
2017-01-03
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 (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.
Secukinumab
Study treatment was provided in pre-filled 1 mL syringes.
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.
Secukinumab
Study treatment was provided in pre-filled 1 mL syringes.
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.
Placebo
Placebo was provided in pre-filled 1 mL syringes.
Interventions
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Secukinumab
Study treatment was provided in pre-filled 1 mL syringes.
Placebo
Placebo was provided in pre-filled 1 mL syringes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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
Birmingham, Alabama, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Skokie, Illinois, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
High Point, North Carolina, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Duncansville, Pennsylvania, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Sydney, New South Wales, Australia
Novartis Investigative Site
Woolloongabba, Queensland, Australia
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Ústí nad Labem, Czech Republic, Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Arhus C, , Denmark
Novartis Investigative Site
Copenhagen NV, , Denmark
Novartis Investigative Site
Hellerup, , Denmark
Novartis Investigative Site
Bad Bentheim, , Germany
Novartis Investigative Site
Bielefeld, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Kiel, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Heraklion, Crete, GR, Greece
Novartis Investigative Site
Athens, , Greece
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Barakaldo, Vizcaya, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
London, England, United Kingdom
Novartis Investigative Site
Staffordshire, Staffordshire, United Kingdom
Novartis Investigative Site
Dudley, West Midlands, United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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2012-005413-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2313
Identifier Type: -
Identifier Source: org_study_id
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