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BIIB092

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02460094Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear PalsyPHASE1 COMPLETED 48Oct 2, 2015Oct 19, 2016Sep 4, 201813 United States
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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 — 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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