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SB683699

Phase 2

Multiple Sclerosis, Relapsing-Remitting | Small molecule | Immunology |GSK plc|Last Updated: Apr 13, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment261
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00097331Three Months Treatment With SB683699 In Patients With Relapsing Multiple SclerosisPHASE2 COMPLETED 261 — — Sep 1, 2004Jul 1, 2006Apr 13, 201511 Belgium, Germany +3
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Study Endpoints
Primary Endpoints
Number of new gadolinium-enhancing lesions on monthly MRI scans
Secondary Endpoints
Number of other lesion types on MRI
Number of relapses during treatment
Expanded Disability Status Scale (EDSS) and MS Functional Composite (MSFC)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
SB683699DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion criteria: * Diagnosis of multiple sclerosis (MS). * Expanded Disability Status Score 0 - 6.5. * One or more relapse of MS in previous 12 months. * Currently not taking any medications for MS (apart from those used to treat symptoms). Exclusion criteria: * Patients with significantly abn...

Countries:BelgiumGermanyPolandRussiaSpain
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