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Serum containing Avonex

Phase 3FDA approved

Multiple Sclerosis | Small molecule | Neurology |Biogen Inc.|Trials Updated: Sep 16, 2013

Serum containing Avonex development status

FDA approval on record Nov 12, 2002
Approval holderBiogen
ApplicationBLA103628
Highest phase Phase 3 (NCT01181115)
Phase scored for BIIBPhase 1
Registered trials 13 across 6 sponsors since Oct 2002

Label indication AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. AVONEX is for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 ) FDA label

Serum containing Avonex target and mechanism

ModalitySmall molecule

Also known as Avonex

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment156

FDA Designations

No designations recorded

Serum containing Avonex clinical trials

Serum containing Avonex · 2 trials · 1 indication

Phase 3 1Phase 1 1
NCT01181115Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)Multiple Sclerosis
COMPLETED60 Analytics
PHASE3COMPLETED
Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

The number and proportion of subjects with adverse events (AEs)
24 weeks
Assessment of clinical laboratory parameters
24 weeks
Assessment of vital signs and physical examinations
24 weeks
Assessment of electrocardiogram (ECG)
24 weeks
Assessment of immunogenicity
24 weeks
Incidence of depression
24 weeks
Incidence of flu-like symptoms
24 weeks
Subject assessment of injection site pain
24 weeks
Clinical assessment of the injection site
24 weeks
To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.
Study duration is 72 days

Secondary Endpoints

Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time
24 weeks
Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
at month 3 and month 6
Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment
at month 3 and month 6
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active treatmentEXPERIMENTALInterferon treatment for MS
Sequence 1EXPERIMENTALSerum containing Avonex followed by serum free Avonex
Sequence 2EXPERIMENTALSerum free Avonex followed by serum containing Avonex

Interventions

NameTypeDescription
AvonexDRUGInterferon treatment for MS
Serum containing AvonexDRUG60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15
Serum Free AvonexDRUG60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Ability to understand risks of study and provide informed consent. * Must be Chinese, aged 18 to 55 years inclusive at time of consent. * Must have diagnosis of relapsing MS of 3 months duration at time of screening visit. * Must have at least 1 documented MS attack within 3 y...

Countries:China
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Frequently asked questions about Serum containing Avonex

What is Serum containing Avonex used for?

Serum containing Avonex is an investigational small molecule being studied for the treatment of Multiple Sclerosis. It is currently in Phase 1 clinical development. The drug is being evaluated for its bioequivalence to a serum-free formulation of Avonex, which is used to treat this condition.

Who makes Serum containing Avonex?

Serum containing Avonex is being developed by Biogen Inc., a biopharmaceutical company. Biogen's stock is traded under the ticker symbol BIIB on the NASDAQ exchange. The company is conducting clinical trials to evaluate this drug for the treatment of Multiple Sclerosis.

What phase is Serum containing Avonex in?

Serum containing Avonex is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its bioequivalence to a serum-free version of Avonex for the treatment of Multiple Sclerosis.

What clinical trials is Serum containing Avonex in?

Serum containing Avonex has one completed clinical trial registered under NCT00913250, titled "A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers." This Phase 1 study enrolled 96 participants and was a controlled, randomized trial, though it was not double-blind.

Is Serum containing Avonex the same as Avonex?

Serum containing Avonex is a formulation of Avonex that includes serum, while Avonex is typically a serum-free formulation. The drug is being studied to determine if the serum-containing version is bioequivalent to the standard serum-free Avonex for the treatment of Multiple Sclerosis.