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BIIB092

Phase 1

Progressive Supranuclear Palsy | Small molecule | Neurology |Biogen Inc.|Last Updated: Sep 4, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

BIIB092 · 1 trial · 1 indication

Phase 1 1
NCT02460094Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear PalsyProgressive Supranuclear Palsy
COMPLETED48 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy
Progressive Supranuclear PalsyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability as Measured by Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 - Day 169

Secondary Endpoints

Percent Change from Baseline in Extracellular Tau (eTau) Concentration in Cerebrospinal Fluid
Day 1 - Day 85
Immunogenicity of BIIB092 Measured by Presence or Absence of Anti-BIIB092 Antibodies in Serum
Day 1 - Day 169
Maximum Serum Concentration (Cmax) of BIIB092
Day 1 - Day 196
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panel 1: BIIB092/ PlaceboEXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Panel 2: BIIB092/ PlaceboEXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Panel 3: BIIB092/ PlaceboEXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.
Panel 4: BIIB092/ PlaceboEXPERIMENTALBIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks.

Interventions

NameTypeDescription
BIIB092DRUGSee Arm Descriptions for dosing information.
PlaceboDRUGSee Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
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Eligibility Criteria

Age Range41 Years to 86 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria 1. Probable or possible PSP defined as: * at least a 12-month history of postural instability or falls during the first 3 years that symptoms are present * a decreased downward saccade velocity at screening defined as observable eye movement deviation from the "main sequen...

Countries:United States
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Frequently asked questions about BIIB092

What is BIIB092 used for in Progressive Supranuclear Palsy?

BIIB092 is an investigational small molecule being developed for the treatment of Progressive Supranuclear Palsy (PSP), a rare neurological disorder. It is administered intravenously and is currently in clinical development, having completed a Phase 1 trial. BIIB092 is not yet approved and remains under investigation for this condition.

Who makes BIIB092?

BIIB092 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical research on this investigational small molecule for Progressive Supranuclear Palsy, with the drug having completed a Phase 1 study.

What phase is BIIB092 in?

BIIB092 is in Phase 1 of clinical development. It has completed a Phase 1 multiple ascending dose study in patients with Progressive Supranuclear Palsy. The drug is investigational and has not received FDA approval, as it remains in early-stage clinical testing.

What clinical trials is BIIB092 in?

BIIB092 has been studied in one completed clinical trial, identified as NCT02460094. This Phase 1 study was a multiple ascending dose trial of intravenously administered BIIB092 in patients with Progressive Supranuclear Palsy. The trial enrolled 48 participants in the United States and was randomized, double-blind, and controlled.

Is BIIB092 the same as BMS-986168?

Yes, BIIB092 is also known as BMS-986168. The completed clinical trial NCT02460094 was titled as a study of BMS-986168 (BIIB092), confirming that these names refer to the same investigational drug. Both names are used interchangeably in clinical research documentation.