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BIIB023

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Biogen Inc.|Trials Updated: Sep 16, 2013

BIIB023 development status

Highest phase Phase 2 (NCT01930890)
Phase scored for BIIBPhase 1
Registered trials 4 across 1 sponsor since Oct 2008

BIIB023 target and mechanism

ModalitySmall molecule

Also known as BIIB023 - low dose IV Dose, BIIB023- low dose Dose, Human glycosylated IgG1 monoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

BIIB023 clinical trials

BIIB023 · 1 trial · 1 indication

Phase 1 1
NCT00771329BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED53 Analytics
PHASE1COMPLETED
BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
Baseline through Day 70

Secondary Endpoints

• Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects
Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBIIB023
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BIIB023DRUGSingle IV doses of BIIB023 in dose-escalating cohorts
Placebo (sterile normal saline)OTHERSingle IV dose of Placebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Diagnosis of adult onset RA (functional class I-III) for at least 6 months * Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks * Must have at least 4 swollen and tender joints due to rheumatoid arthrit...

Countries:United StatesRussia
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Frequently asked questions about BIIB023

What is BIIB023 used for?

BIIB023 is an investigational small molecule being studied for the treatment of rheumatoid arthritis, an inflammatory autoimmune condition affecting the joints. It was evaluated in a Phase 1 clinical trial in adults with rheumatoid arthritis. BIIB023 is not approved for any indication and remains in clinical development.

Who is developing BIIB023?

BIIB023 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the Phase 1 clinical trial of BIIB023 in rheumatoid arthritis. The company is the sole developer identified for this asset.

What phase is BIIB023 in?

BIIB023 is in Phase 1 clinical development. It has completed one Phase 1 trial in rheumatoid arthritis, and no active trials are currently listed. BIIB023 is investigational and has not been approved by the FDA for any use.

What clinical trials is BIIB023 in?

BIIB023 has been studied in one completed Phase 1 trial, NCT00771329, titled "BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis." The trial enrolled 53 participants across the United States and Russia. It was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.

Is BIIB023 the same as BIIB023 low dose IV Dose?

Yes, BIIB023 is also referred to as BIIB023 low dose IV Dose and BIIB023 low dose Dose. These names describe the low-dose intravenous formulation evaluated in its Phase 1 rheumatoid arthritis trial. All refer to the same investigational compound developed by Biogen.