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BG00002-E

Phase 2

Multiple Sclerosis | Monoclonal antibody | Neurology |Biogen Inc.|Last Updated: May 15, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment113

FDA Designations

No designations recorded

Clinical trial landscape

BG00002-E · 1 trial · 1 indication

Phase 2 1
NCT00516893Natalizumab High Titer Immunogenicity and SafetyMultiple Sclerosis
COMPLETED113 Analytics
PHASE2COMPLETED
Natalizumab High Titer Immunogenicity and Safety
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status
Assessed every 12 weeks from Week 0 (Baseline) to Week 36

Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.

Secondary Endpoints

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
AEs: collected from Baseline (Week 0) until Week 36 or premature withdrawal. SAEs: collected from informed consent until Week 36 or premature withdrawal.
Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36
Baseline, Week 36
Annualized Relapse Rate
Through Week 36
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
Natalizumab High TiterEXPERIMENTALnatalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses

Interventions

NameTypeDescription
BG00002-E (natalizumab high titer)BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Diagnosis of a relapsing form of MS * Must fall within the therapeutic indications stated in the locally approved label for natalizumab * Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Prior treatment with natalizumab * Considered by investigator t...

Countries:United States
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Frequently asked questions about BG00002-E

What is BG00002-E used for?

BG00002-E is a monoclonal antibody being developed for the treatment of Multiple Sclerosis. It is currently in Phase 2 clinical development and is being studied in patients with this condition.

What does BG00002-E target?

BG00002-E is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential role in treating Multiple Sclerosis.

Who is developing BG00002-E?

BG00002-E is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is BG00002-E in?

BG00002-E is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is BG00002-E in?

BG00002-E has been studied in a completed Phase 2 clinical trial with the identifier NCT00516893. This trial, titled 'Natalizumab High Titer Immunogenicity and Safety', enrolled 113 participants with Multiple Sclerosis in the United States.

Is BG00002-E the same as natalizumab?

BG00002-E is a monoclonal antibody being developed for Multiple Sclerosis. The completed clinical trial for BG00002-E was titled 'Natalizumab High Titer Immunogenicity and Safety', but it has not been confirmed whether BG00002-E is the same as natalizumab.