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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03068468




Registration number
NCT03068468
Ethics application status
Date submitted
27/02/2017
Date registered
1/03/2017
Date last updated
21/12/2020

Titles & IDs
Public title
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
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
Secondary ID [1] 0 0
2016-002554-21
Secondary ID [2] 0 0
251PP301
Universal Trial Number (UTN)
Trial acronym
PASSPORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Supranuclear Palsy, Progressive 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB092
Treatment: Drugs - Placebo

Experimental: 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.

Placebo comparator: 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.


Treatment: Drugs: BIIB092
BIIB092 intravenous infusion on specified days

Treatment: Drugs: Placebo
Placebo intravenous infusion on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52
Timepoint [1] 0 0
Baseline, Week 52
Primary outcome [2] 0 0
Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug
Timepoint [2] 0 0
up to 52 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Clinical Global Impression of Change (CGI-C) Scale Score
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52
Timepoint [3] 0 0
Baseline, Week 52
Secondary outcome [4] 0 0
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48
Timepoint [6] 0 0
Baseline, Week 48
Secondary outcome [7] 0 0
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change From Baseline in Phonemic Fluency Test Score at Week 48
Timepoint [8] 0 0
Baseline, Week 48
Secondary outcome [9] 0 0
Change From Baseline in Letter-Number Sequencing Test at Week 48
Timepoint [9] 0 0
Baseline, Week 48
Secondary outcome [10] 0 0
Change From Baseline in Color Trails at Week 48
Timepoint [10] 0 0
Baseline, Week 48
Secondary outcome [11] 0 0
Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48
Timepoint [11] 0 0
Baseline, Week 48
Secondary outcome [12] 0 0
Number of Participants With Treatment Emergent Antibodies (Anti-BIIB092) Positive Results in Serum
Timepoint [12] 0 0
Up to Week 48
Secondary outcome [13] 0 0
Change From Baseline of Brain Volumes as Determined by MRI at Week 52
Timepoint [13] 0 0
Baseline, Week 52

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
41 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/02/2020
Sample size
Target
Accrual to date
Final
490
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - North Melbourne
Recruitment postcode(s) [1] 0 0
- North Melbourne
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Indiana
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Kansas
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New York
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Washington
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Austria
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Tirol
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Austria
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Vienna
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Canada
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Ontario
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France
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Bordeaux
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France
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Lille
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Bavaria
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Hessen
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Germany
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Mecklenburg-Western-Pommerania
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Germany
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North Rhine-Westphalia
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Ulm
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Greece
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Campania
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Italy
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Pisa
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Tottori
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Shizuoka
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Korea, Republic of
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Seoul
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Krasnoyarsk
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Moscow
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Valencia
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Cambridgeshire
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East Sussex
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Hampshire
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Merseyside
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Tyne And Wear
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Wales
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03068468