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dirucotide

Phase 2

Relapsing Remitting Multiple Sclerosis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Sep 9, 2010

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment218
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00869986A Study for Patients With Relapsing Remitting Multiple SclerosisPHASE2 COMPLETED 218 — — Nov 1, 2006Sep 1, 2009Sep 9, 20106 Bulgaria, Poland +4
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Study Endpoints
Primary Endpoints
Annualized relapse rate
15 months
Secondary Endpoints
Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)
baseline, 15, 24 and 27 months
Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)
baseline, 15, 24 and 27 months
Proportion of patients relapse-free
15, 24, and 27 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DirucotideEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
dirucotideDRUG500mg, intravenous, every 6 months for 15 months
placeboDRUGintravenous, once every six months for 15 months
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Male or female subjects, 18-50 years of age 2. Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846) 3. At least 2 years history of MS before trial ent...

Countries:BulgariaPolandRussiaSerbiaSlovakiaUkraine
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