Study of BIIB092 in Participants With Progressive Supranuclear Palsy
NCT ID: NCT03068468
Last Updated: 2020-12-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
490 participants
INTERVENTIONAL
2017-06-01
2020-02-07
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BIIB092
Participants will receive BIIB092 50 mg/ml intravenous (IV) infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.
BIIB092
BIIB092 intravenous infusion on specified days
Placebo
Participants will receive BIIB092 matching placebo IV infusion once every 4 weeks for 48 weeks in double blind treatment period followed by BIIB092 50 mg/ml IV infusion once every 4 weeks starting at Week 52 up to Week 208.
Placebo
Placebo intravenous infusion on specified days
Interventions
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BIIB092
BIIB092 intravenous infusion on specified days
Placebo
Placebo intravenous infusion on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
41 Years
86 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Sun City, Arizona, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Boca Raton, Florida, United States
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Gainesville, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Minneapolis, Minnesota, United States
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New Brunswick, New Jersey, United States
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Albany, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Charlottesville, Virginia, United States
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Seattle, Washington, United States
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North Melbourne, Victoria, Australia
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Innsbruck, Tyrol, Austria
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Vienna, , Austria
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Bordeaux, , France
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Lille, , France
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Marseille, , France
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Nîmes, , France
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Paris, , France
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Rennes, , France
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Toulouse, , France
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Munich, Bavaria, Germany
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Marburg, Hesse, Germany
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Rostock, Mecklenburg-Western-Pommerania, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Lübeck, Schleswig-Holstein, Germany
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Beelitz-Heilstätten, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Essen, , Germany
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Kassel, , Germany
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Ulm, , Germany
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Athens, Marousi, Greece
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Salerno, Campania, Italy
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Pisa, , Italy
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Venice-Lido, , Italy
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Nagoya, Aichi-ken, Japan
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Kamagaya, Chiba, Japan
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Sapporo, Hokkaido, Japan
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Sagamihara, Kanagawa, Japan
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Kodaira, Tokyo, Japan
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Yonago, Tottori, Japan
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Shizuoka, , Japan
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Seoul, , South Korea
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Pamplona, Navarre, Spain
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Barakaldo, Vizcaya, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Seville, , Spain
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Valencia, , Spain
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Cambridge, Cambridgeshire, United Kingdom
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Brighton, East Sussex, United Kingdom
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Southampton, Hampshire, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, United Kingdom
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Newport, Wales, United Kingdom
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London, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002554-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CN002-012
Identifier Type: OTHER
Identifier Source: secondary_id
251PP301
Identifier Type: -
Identifier Source: org_study_id