JPRN-jRCT2080222132UnknownPhase 2
A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
ovartis Pharma K.K.0 sites380 target enrollmentStarted: July 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 380
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to <= 55age old (—)
- Sex
- All
Inclusion Criteria
- •*Diagnosis of Multiple Sclerosis according to 2010 revised McDonald 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
- •*Active chronic disease of the immune system other than multiple sclerosis
- •*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
- •*Other protocol-defined inclusion/exclusion criteria may apply.
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