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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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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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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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Lille
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Paris
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Rennes
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France
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Toulouse
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Germany
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Bavaria
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Germany
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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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Germany
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Beelitz-Heilstatten
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Germany
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Bochum
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Germany
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Bonn
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Essen
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Kassel
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Germany
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Ulm
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Greece
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Marousi
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Italy
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Campania
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Italy
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Pisa
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Italy
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Venice Lido
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Aichi
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Chiba
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Hokkaido
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Kanagawa
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Tokyo
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Tottori
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Japan
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Shizuoka
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Korea, Republic of
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Seoul
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Spain
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Navarra
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Vizcaya
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Barcelona
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Madrid
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Sevilla
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Valencia
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United Kingdom
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Cambridgeshire
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United Kingdom
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East Sussex
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Hampshire
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United Kingdom
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Merseyside
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United Kingdom
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT03068468
Trial related presentations / publications
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. Erratum In: Nat Med. 2023 Nov;29(11):2955-2956. doi: 10.1038/s41591-022-02076-8.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03068468