Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
NCT ID: NCT01874340
Last Updated: 2015-06-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
28 participants
INTERVENTIONAL
2013-06-30
2014-04-30
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
TRIPLE
Study Groups
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AIN457 low dose
AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.
AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.
Placebo
Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2).
Placebo
Placebo will be administered at predefined visits over the 6-month treatment phase.
AIN457 middle dose
AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis
AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.
AIN457 high dose
AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.
AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.
Interventions
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Placebo
Placebo will be administered at predefined visits over the 6-month treatment phase.
AIN457
AIN457 will be administered at predefined visits over the 6-month treatment phase.
Eligibility Criteria
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Inclusion Criteria
* Disease duration of 10 years or less
* At least one relapse in the last year
* EDSS score 0 to 5.0 at entry
Exclusion Criteria
* History of malignancy within the past 5 years
* Active systemic bacterial, viral or fungal infections
* Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)
* Any medically unstable condition
* Unable to undergo MRI scans or repeated blood tests
* Pregnant or nursing females
* Women of child-bearing potential must use reliable forms of contraception
18 Years
55 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
Bruges, , Belgium
Novartis Investigative Site
Jihlava, , Czechia
Novartis Investigative Site
Saint-Herblain, , France
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Poznan, , Poland
Novartis Investigative Site
Moscow, , Russia
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Bilbao, Basque Country, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
Atakum / Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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2012-004019-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457B2203
Identifier Type: -
Identifier Source: org_study_id
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