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IFN beta 1a TIW

Phase 2

Multiple Sclerosis | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Jan 22, 2019

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01514370Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1aPHASE2 COMPLETED 80Apr 30, 2012Mar 31, 2016Jan 22, 20191 Italy
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Study Endpoints
Primary Endpoints
Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12
Month 12

A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan.

Secondary Endpoints
Percentage of Relapse-Free Subjects at Month 12 and Month 24
Month 12 and 24
Annualized Relapse Rate at Month 12 and 24
Month 12 and 24
Total Number of Reported Relapses at Month 3, 6, 12 and 24
Month 3, 6, 12 and 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IFN beta 1a 44 mcg TIW + curcumin (BCM95)EXPERIMENTAL -
IFN beta 1a 44 mcg TIW + placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
IFN beta 1a 44 mcg TIWDRUGSubjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months.
CurcuminDRUGSubjects received 500 milligram (mg) curcumin orally twice a day for 24 months.
PlaceboDRUGSubjects received placebo matched to curcumin orally twice a day for 24 months.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects with early diagnosis (no more than 3 years) of Relapsing Multiple Sclerosis according to the revised McDonald Criteria (2010) * Subjects currently in treatment with IFN beta-1a 44 mcg TIW, having received this treatment a minimum of 6 months and for not longer than 12...

Countries:Italy
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