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IFN beta 1a TIW

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

IFN beta 1a TIW · 1 trial · 1 indication

Phase 2 1
NCT01514370Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1aMultiple Sclerosis
COMPLETED80 Analytics
PHASE2COMPLETED
Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a
Multiple SclerosisUnlock trial analytics

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 to 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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Frequently asked questions about IFN beta 1a TIW

What is IFN beta 1a TIW used for in multiple sclerosis?

IFN beta 1a TIW is an investigational small molecule being studied for the treatment of multiple sclerosis. It is administered three times per week. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing IFN beta 1a TIW?

IFN beta 1a TIW is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this drug for multiple sclerosis, and the drug is currently in Phase 2 development.

What phase is IFN beta 1a TIW in?

IFN beta 1a TIW is in Phase 2 clinical development. It is an investigational drug for multiple sclerosis and has not been approved for commercial use. One Phase 2 clinical trial has been completed for this drug.

What clinical trials has IFN beta 1a TIW been in?

IFN beta 1a TIW has been studied in one completed Phase 2 clinical trial, registered as NCT01514370. This trial evaluated the drug in 80 participants with multiple sclerosis in Italy. The study was randomized, double-blind, and placebo-controlled.

Is IFN beta 1a TIW the same as interferon beta 1a?

IFN beta 1a TIW is a form of interferon beta 1a, specifically dosed three times per week. It is being investigated as a treatment for multiple sclerosis. The drug is in Phase 2 development and is not yet approved.