Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Tirol
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux
Country [23] 0 0
France
State/province [23] 0 0
Lille
Country [24] 0 0
France
State/province [24] 0 0
Marseille
Country [25] 0 0
France
State/province [25] 0 0
Nimes
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Rennes
Country [28] 0 0
France
State/province [28] 0 0
Toulouse
Country [29] 0 0
Germany
State/province [29] 0 0
Bavaria
Country [30] 0 0
Germany
State/province [30] 0 0
Hessen
Country [31] 0 0
Germany
State/province [31] 0 0
Mecklenburg-Western-Pommerania
Country [32] 0 0
Germany
State/province [32] 0 0
North Rhine-Westphalia
Country [33] 0 0
Germany
State/province [33] 0 0
Sachsen
Country [34] 0 0
Germany
State/province [34] 0 0
Schleswig-Holstein
Country [35] 0 0
Germany
State/province [35] 0 0
Beelitz-Heilstatten
Country [36] 0 0
Germany
State/province [36] 0 0
Bochum
Country [37] 0 0
Germany
State/province [37] 0 0
Bonn
Country [38] 0 0
Germany
State/province [38] 0 0
Essen
Country [39] 0 0
Germany
State/province [39] 0 0
Kassel
Country [40] 0 0
Germany
State/province [40] 0 0
Ulm
Country [41] 0 0
Greece
State/province [41] 0 0
Marousi
Country [42] 0 0
Italy
State/province [42] 0 0
Campania
Country [43] 0 0
Italy
State/province [43] 0 0
Pisa
Country [44] 0 0
Italy
State/province [44] 0 0
Venice Lido
Country [45] 0 0
Japan
State/province [45] 0 0
Aichi
Country [46] 0 0
Japan
State/province [46] 0 0
Chiba
Country [47] 0 0
Japan
State/province [47] 0 0
Hokkaido
Country [48] 0 0
Japan
State/province [48] 0 0
Kanagawa
Country [49] 0 0
Japan
State/province [49] 0 0
Tokyo
Country [50] 0 0
Japan
State/province [50] 0 0
Tottori
Country [51] 0 0
Japan
State/province [51] 0 0
Shizuoka
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Seoul
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Krasnoyarsk
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Moscow
Country [55] 0 0
Spain
State/province [55] 0 0
Navarra
Country [56] 0 0
Spain
State/province [56] 0 0
Vizcaya
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Sevilla
Country [60] 0 0
Spain
State/province [60] 0 0
Valencia
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Cambridgeshire
Country [62] 0 0
United Kingdom
State/province [62] 0 0
East Sussex
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Hampshire
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Merseyside
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Tyne And Wear
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Wales
Country [67] 0 0
United Kingdom
State/province [67] 0 0
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