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Avonex

Phase 3

Multiple Sclerosis | Small molecule | Neurology |Biogen Inc.|Last Updated: Nov 17, 2017

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Avonex · 3 trials · 3 indications

Phase 3 1Phase 1 2
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
Cmax
Participants will be followed for the duration of the study; and expected 2 months
Tmax
Participants will be followed for the duration of the study; and expected 2 months
AUC 0-t
Participants will be followed for the duration of the study; and expected 2 months
AUC 0-infinity
Participants will be followed for the duration of the study; and expected 2 months
T 1/2
Participants will be followed for the duration of the study; and expected 2 months
Tlag
Participants will be followed for the duration of the study; and expected 2 months
Ka
Participants will be followed for the duration of the study; and expected 2 months
T 1/2ab
Participants will be followed for the duration of the study; and expected 2 months
Kcl
Participants will be followed for the duration of the study; and expected 2 months
Kir
Participants will be followed for the duration of the study; and expected 2 months
Emax
Participants will be followed for the duration of the study; and expected 2 months
Tmax(E)
Participants will be followed for the duration of the study; and expected 2 months
Eauc
Participants will be followed for the duration of the study; and expected 2 months
Induction ratio
Participants will be followed for the duration of the study; and expected 2 months
T1/2 return to baseline
Participants will be followed for the duration of the study; and expected 2 months
To determine whether titration of Avonex reduces the incidence of flu like symptoms
8 weeks

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
AvonexEXPERIMENTAL4 weekly injections of Avonex (IM)
Group 1EXPERIMENTALNo dose titration
Group 2EXPERIMENTALFast dose titration
Group 3EXPERIMENTALSlow dose titration

Interventions

NameTypeDescription
AvonexDRUGInterferon treatment for MS
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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:ChinaUnited States
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Frequently asked questions about Avonex

What is Avonex used for?

Avonex is used for the treatment of relapsing multiple sclerosis (MS). It has been studied in Chinese subjects with relapsing MS to evaluate its safety and tolerability. Avonex is also being investigated in healthy volunteers to assess its effects, including the incidence of flu-like symptoms and its pharmacokinetic and pharmacodynamic profile.

Who makes Avonex?

Avonex is developed by Biogen Inc., a biotechnology company listed on the NASDAQ under the ticker symbol BIIB. Biogen is responsible for the clinical development and commercialization of Avonex.

What phase is Avonex in?

Avonex is in clinical development. It has completed Phase 1 trials in healthy volunteers, including a study on dose titration and a pharmacokinetic study in Chinese subjects. It has also completed a Phase 3 trial in Chinese subjects with relapsing multiple sclerosis.

What clinical trials is Avonex in?

Avonex has been studied in several completed clinical trials. NCT01119677 is a Phase 1 study in healthy volunteers examining dose titration effects on flu-like symptoms. NCT01181115 is a Phase 3 safety and tolerability study in Chinese subjects with relapsing MS. NCT01416207 is a Phase 1 pharmacokinetic and pharmacodynamic study in Chinese healthy volunteers.

Is Avonex the same as other drugs?

Avonex is a specific drug product developed by Biogen Inc. It is not referred to by any alternative names in the clinical trial records. The trials listed for Avonex use the name Avonex exclusively.