Clinical trial NCT03068468: Study of BIIB092 in Participants With Progressive Supranuclear Palsy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Supranuclear Palsy, Progressive
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 490
Sex: ALL
Minimum age (years): 41
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 \& 4 laboratory abnormalities.

The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

Detailed description: This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Eligibility criteria: Key Inclusion Criteria:

* Participants with probable or possible PSP
* Able to ambulate independently or with assistance
* Able to tolerate MRI
* Have reliable caregiver to accompany participant to all study visits
* Score greater or equal to 20 on the Mini Mental State Exam (MMSE) at screening
* Participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned

Key Exclusion Criteria:

* Presence of other significant neurological or psychiatric disorders
* Diagnosis of amyotrophic lateral sclerosis (ALS) or other motor neuron disease
* History of early, prominent rapid eye movement (REM) sleep behavior disorder
* History of or screening brain MRI scan indicative of significant abnormality
* Known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Change From Baseline in Movement Disorder Society (MDS)-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52
timeFrame: Baseline, Week 52
measure: Clinical Global Impression of Change (CGI-C) Scale Score
timeFrame: Week 52
measure: Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score
timeFrame: Baseline, Week 52
measure: Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Phonemic Fluency Test Score at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Letter-Number Sequencing Test at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Color Trails at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48
timeFrame: Baseline, Week 48
measure: Number of Participants With Treatment Emergent Antibodies (Anti-BIIB092) Positive Results in Serum
timeFrame: Up to Week 48
measure: Change From Baseline of Brain Volumes as Determined by MRI at Week 52
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Sun City
country: United States
facility: Research Site
state: Arizona
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Name
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Kansas City
country: United States
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state: Kansas
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Burlington
country: United States
facility: Research Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Research Site
state: Michigan
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: New Brunswick
country: United States
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state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Dallas
country: United States
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state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: North Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Innsbruck
country: Austria
facility: Research Site
state: Tirol
city: Vienna
country: Austria
facility: Research Site
city: London
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Bordeaux
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Munich
country: Germany
facility: Research Site
state: Bavaria
city: Marburg
country: Germany
facility: Research Site
state: Hessen
city: Rostock
country: Germany
facility: Research Site
state: Mecklenburg-Western-Pommerania
city: Dusseldorf
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Kiel
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Beelitz-Heilstatten
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
state: Marousi
city: Salerno
country: Italy
facility: Research Site
state: Campania
city: Pisa
country: Italy
facility: Research Site
city: Venice Lido
country: Italy
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Kamagaya
country: Japan
facility: Research Site
state: Chiba
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Sagamihara
country: Japan
facility: Research Site
state: Kanagawa
city: Kodaira
country: Japan
facility: Research Site
state: Tokyo
city: Yonago
country: Japan
facility: Research Site
state: Tottori
city: Shizuoka
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Barakaldo
country: Spain
facility: Research Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
state: Cambridgeshire
city: Brighton
country: United Kingdom
facility: Research Site
state: East Sussex
city: Southampton
country: United Kingdom
facility: Research Site
state: Hampshire
city: Liverpool
country: United Kingdom
facility: Research Site
state: Merseyside
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
state: Tyne And Wear
city: Newport
country: United Kingdom
facility: Research Site
state: Wales
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Jaeger J, Yang L, Li Y, Castrillo-Viguera C, Haeberlein SB, Dam T, O'Gorman J. Development of a cognitive composite for measuring change in progressive supranuclear palsy. Parkinsonism Relat Disord. 2021 Nov;92:94-100. doi: 10.1016/j.parkreldis.2021.10.007. Epub 2021 Oct 12.
citation: Dam T, Boxer AL, Golbe LI, Hoglinger GU, Morris HR, Litvan I, Lang AE, Corvol JC, Aiba I, Grundman M, Yang L, Tidemann-Miller B, Kupferman J, Harper K, Kamisoglu K, Wald MJ, Graham DL, Gedney L, O'Gorman J, Haeberlein SB; PASSPORT Study Group. Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial. Nat Med. 2021 Aug;27(8):1451-1457. doi: 10.1038/s41591-021-01455-x. Epub 2021 Aug 12.