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BIIB023

Phase 1

Healthy | Monoclonal antibody | Other |Biogen Inc.|Last Updated: Sep 3, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

BIIB023 · 2 trials · 2 indications

Phase 1 2
NCT01943513A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male VolunteersHealthy
COMPLETED34 Analytics
NCT00771329BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED53 Analytics
PHASE1COMPLETED
A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage change in the magnitude of muscle atrophy
between Day 14 and Day 42
Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
Baseline through Day 70

Secondary Endpoints

Percentage change in the magnitude of muscle atrophy, measured by T1W-MRI analysis of the CSA of the triceps surae muscles of the immobilized limb
between Day 14 and Day 42
Percentage change in isometric knee-extension strength (torque), measured by dynamometry
between Day 14 and Day 42
Percentage change in isometric plantar-flexion strength (torque), measured by dynamometry
between Day 14 and Day 42
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BIIB023EXPERIMENTALParticipants receive intravenous (IV) infusions of BIIB023
PlaceboPLACEBO_COMPARATORParticipants receive intravenous (IV) infusions of placebo
1EXPERIMENTALBIIB023
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BIIB023BIOLOGICALIntravenous (IV) infusions
PlaceboBIOLOGICALMatched placebo
Placebo (sterile normal saline)OTHERSingle IV dose of Placebo
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Eligibility Criteria

Age Range18 Years to 35 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Deemed healthy as determined by the Investigator based on medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters at Screening, and physical examination at Baseline * Body mass index (BMI) between 18.5 and 32 kg/m2, inclusive, at the tim...

Countries:United StatesRussia
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Frequently asked questions about BIIB023

What is BIIB023 used for?

BIIB023 is an investigational monoclonal antibody being studied for use in rheumatoid arthritis and in healthy volunteers. It has been evaluated in Phase 1 clinical trials for these conditions, though it is not approved and remains in clinical development.

What does BIIB023 target?

BIIB023 is an anti-TWEAK monoclonal antibody, meaning it targets the cytokine TWEAK. It was studied in a Phase 1 trial in subjects with rheumatoid arthritis to assess its effects, though no efficacy data from that trial is available here.

Who makes BIIB023?

BIIB023 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker BIIB. Biogen has sponsored the clinical trials of BIIB023 in rheumatoid arthritis and healthy volunteer studies.

What phase is BIIB023 in?

BIIB023 is in Phase 1 clinical development. All three completed trials of BIIB023 were Phase 1 studies, including trials in rheumatoid arthritis and healthy volunteers. It is investigational and has not been approved by regulatory authorities.

What clinical trials is BIIB023 in?

BIIB023 has been studied in three completed Phase 1 trials: NCT00771329 in rheumatoid arthritis, NCT01407406 in healthy volunteers of different ethnicities, and NCT01943513 in healthy male volunteers for muscle atrophy. All trials are completed.

Is BIIB023 the same as anti-TWEAK?

BIIB023 is an anti-TWEAK monoclonal antibody, and the trial NCT00771329 is titled 'BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis.' This indicates BIIB023 is the drug being evaluated as an anti-TWEAK agent in that study.