Study of BIIB092 in Participants With Progressive Supranuclear Palsy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03068468
• Date of registration: 27/02/2017
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Study of BIIB092 in Participants With Progressive Supranuclear Palsy PASSPORT
• Scientific 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
• Date of first enrolment: June 1, 2017
• Target sample size: 490
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03068468
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Canada, France, Germany, Greece, Italy, Japan, Korea, Republic of, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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



Age minimum: 41 Years
Age maximum: 86 Years
Gender: All

Health Condition(s) or Problem(s) studied

Supranuclear Palsy, Progressive

Intervention(s)

Drug: BIIB092

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 [Time Frame: Baseline, Week 52]

Percentage of Participants with Death, Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation, and Grade 3 and 4 Laboratory Abnormalities [Time Frame: Up to 52 Weeks]

Secondary Outcome(s)

Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52 [Time Frame: Baseline, Week 52]

Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48 [Time Frame: Baseline, Week 48]

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52 [Time Frame: Baseline, Week 52]

Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score [Time Frame: Baseline, Week 52]

Clinical Global Impression of Change (CGI-C) Scale Score [Time Frame: Week 52]

Change From Baseline in Letter-Number Sequencing Test at Week 48 [Time Frame: Baseline, Week 48]

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 [Time Frame: Baseline, Week 52]

Change From Baseline in Phonemic Fluency Test Score at Week 48 [Time Frame: Baseline, Week 48]

Percent Change from Baseline of Brain Volumes as Determined by MRI [Time Frame: Up to Week 52]

Change From Baseline in Color Trails Test at Week 48 [Time Frame: Baseline, Week 48]

Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48 [Time Frame: Baseline, Week 48]

Number of Participants with Drug Antibodies (anti-BIIB092) in Serum [Time Frame: Up to Week 52]

Secondary ID(s)

2016-002554-21

251PP301

CN002-012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors