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Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PASSPORT)

Primary Purpose

Supranuclear Palsy, Progressive

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB092
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supranuclear Palsy, Progressive

Eligibility Criteria

41 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BIIB092

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52
The PSPRS is a quantitative measure of disability in participants with PSP. The PSPRS comprises 28 items in 6 areas. Six items are rated on a 3-point scale (0-2) and 22 are rated on a 5-point scale (0-4). The 6 areas are the History/Daily Activities, Mentation, Bulbar, Ocular Motor, Limb Motor, and Gait. The 28-item PSPRS total score ranges from 0 (normal) to 100. Fifteen items are selected to form a 15-item PSPRS and three domains are identified: Gait/Limb function, Ocular Motor, and Bulbar. The total 15-item PSPRS score ranges from 0 (normal) to 52. A positive change from baseline indicates worsening.
Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity.

Secondary Outcome Measures

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
The MDS-UPRDRS Part 2 includes 13 items assessing motor aspects of experiences of daily living (M-EDL) these include speech, saliva and drooling, chewing and swallowing, handwriting, doing hobbies and other activities, eating tasks, tremor, dressing, hygiene, turning in bed, getting out of bed, walking and balance, and freezing. All items have 5 responses with uniform anchors of 0= normal, 1= slight, 2= mild, 3= moderate, and 4= severe. Total score ranges from 0 to 52, higher score indicating severe conditions. A positive change from baseline indicates worsening.
Clinical Global Impression of Change (CGI-C) Scale Score
The CGI-C scale measures the change in the patient's clinical status from a specific point in time. Using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.
Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52
The PSP cognitive composite battery is used to identify and characterize abnormal cognitive decline in PSP participants. The PSP cognitive composite battery includes 13 sub-tests in total: 11 tests from the RBANS (only the picture naming is excluded), letter number sequencing test, and phonemic fluency test. Three domains are identified: Memory and learning, Visual-Motor function, and Working memory and Executive. A z-score transformation is applied for each component test at each visit, and the final total composite z-score is the average of the three-domain z-scores. A z-score of 0 is equal to the estimated mean adjusted by age and is considered average for this study population. Lower values are indicative of cognitive decline. A negative change from baseline indicates worsening.
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52
The RBANS provides both a total scale score and scores for 5 different cognitive domains. Specifically, the test measures immediate memory, visuospatial/constructional ability, language, attention, and delayed memory. Scores from all subtests are aggregated into a total composite score. RBANS data were age-normed and analyzed as index scores (also referred to as standard scores), which have a mean of 100 and a standard deviation of 15. Higher scores on each sub measure and index indicate better performance. A negative change from baseline indicates worsening.
Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score
The PSP-QoL is a patient-reported outcome measure developed specifically for assessing the health-related quality of life in people living with PSP. It is validated 45-item questionnaire and visual analog scale that is comprised of 2 subscales: physical health state (22 items), which covers mobility, dysarthria, dysphagia, visual disturbances, self-care, and activities of daily living, and mental health state (23 items), which covers emotional, cognitive and social functioning. Items are given a 6-reponse option format (No Problem, Slight Problem, Moderate Problem, Marked Problem, Extreme Problem and Not Applicable). The subscale results are derived by summing the respective items for that subscale and transforming the scores into a range of 0 to 100, the higher the scores indicating a greater impact of the disease on the aspect measured. The PSP-QoL also comprises of a Life Satisfaction rating gauge, which is a visual analog scale with a range of 0 (worst) to 100 (best).
Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48
The SEADL scale is a means of assessing a person's ability to perform daily activities in terms of speed and independence, with 100% indicating total independence, falling to 0%, which indicates a state of complete dependence. The individual is asked to rate his or her function using an 11-point scale (10% increments), from 100% (completely independent; able to do all chores without slowness, difficulty, or impairment; essentially normal; unaware of any difficulty) to 0% (vegetative functions such as swallowing, bladder and bowels are not functioning; bedridden). A negative change from baseline indicates worsening.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52
The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in participants with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Change From Baseline in Phonemic Fluency Test Score at Week 48
Phonemic fluency is a sensitive test for assessing frontal lobe dysfunction. Participants are given a letter of the alphabet and asked to name as many words as they can that start with that letter in 1 minute. The score for each trial is auto-calculated as follows: Trial 1: Total number of correct responses for the first letter (range 0 to 40); Trial 2: Total number of correct responses for the second letter (range 0 to 40). The total score from the two trials will be used for analysis (range 0 to 80). More number of words correlates to better phonemic fluency. A negative change from baseline indicates worsening.
Change From Baseline in Letter-Number Sequencing Test at Week 48
Letter number is a test of working memory which involves ordering a series of up to 8 letters and numbers in which the numbers are repeated back first in order starting with the lowest number, then followed by the letters in alphabetical order. LNS consists of 10 items and each item has 3 trials rated as Incorrect (0) or Correct (1). The LNS total raw score (range 0 to 30) is auto-calculated by summing the 10 individual item scores (range 0 to 3 for each item). Higher number of correct items correlated to better performance and a negative change from baseline indicates worsening.
Change From Baseline in Color Trails at Week 48
The Color Trails test is a language free version of the Trail Making Test and was developed to allow for broader cross cultural assessment. For Part 1 (color trails test 1), the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2 (color trails test 2), the respondent rapidly connects number circles in sequence, but alternates between pink and yellow background. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors. Less time indicates better performance. A positive change from baseline indicates worsening.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48
The MOCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Scores on the MOCA range from 0-30, with higher score being better performance. A negative change from baseline indicates worsening.
Number of Participants With Treatment Emergent Antibodies (Anti-BIIB092) Positive Results in Serum
Change From Baseline of Brain Volumes as Determined by MRI at Week 52
A 3 dimension (3D) T1-weighted MRI was performed to estimate brain volumes (e.g., ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, and frontal lobes).

Full Information

First Posted
February 27, 2017
Last Updated
November 25, 2020
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT03068468
Brief Title
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
Acronym
PASSPORT
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
251PP301(PASSPORT) primary endpoint was not met;Biogen decision to close the study early. There were no safety concerns with the PASSPORT study.
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 6, 2019 (Actual)
Study Completion Date
February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supranuclear Palsy, Progressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIIB092
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BIIB092
Other Intervention Name(s)
BMS-986168
Intervention Description
BIIB092 intravenous infusion on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo intravenous infusion on specified days
Primary Outcome Measure Information:
Title
Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52
Description
The PSPRS is a quantitative measure of disability in participants with PSP. The PSPRS comprises 28 items in 6 areas. Six items are rated on a 3-point scale (0-2) and 22 are rated on a 5-point scale (0-4). The 6 areas are the History/Daily Activities, Mentation, Bulbar, Ocular Motor, Limb Motor, and Gait. The 28-item PSPRS total score ranges from 0 (normal) to 100. Fifteen items are selected to form a 15-item PSPRS and three domains are identified: Gait/Limb function, Ocular Motor, and Bulbar. The total 15-item PSPRS score ranges from 0 (normal) to 52. A positive change from baseline indicates worsening.
Time Frame
Baseline, Week 52
Title
Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug
Description
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity.
Time Frame
up to 52 weeks
Secondary Outcome Measure Information:
Title
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
Description
The MDS-UPRDRS Part 2 includes 13 items assessing motor aspects of experiences of daily living (M-EDL) these include speech, saliva and drooling, chewing and swallowing, handwriting, doing hobbies and other activities, eating tasks, tremor, dressing, hygiene, turning in bed, getting out of bed, walking and balance, and freezing. All items have 5 responses with uniform anchors of 0= normal, 1= slight, 2= mild, 3= moderate, and 4= severe. Total score ranges from 0 to 52, higher score indicating severe conditions. A positive change from baseline indicates worsening.
Time Frame
Baseline, Week 52
Title
Clinical Global Impression of Change (CGI-C) Scale Score
Description
The CGI-C scale measures the change in the patient's clinical status from a specific point in time. Using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.
Time Frame
Week 52
Title
Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52
Description
The PSP cognitive composite battery is used to identify and characterize abnormal cognitive decline in PSP participants. The PSP cognitive composite battery includes 13 sub-tests in total: 11 tests from the RBANS (only the picture naming is excluded), letter number sequencing test, and phonemic fluency test. Three domains are identified: Memory and learning, Visual-Motor function, and Working memory and Executive. A z-score transformation is applied for each component test at each visit, and the final total composite z-score is the average of the three-domain z-scores. A z-score of 0 is equal to the estimated mean adjusted by age and is considered average for this study population. Lower values are indicative of cognitive decline. A negative change from baseline indicates worsening.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52
Description
The RBANS provides both a total scale score and scores for 5 different cognitive domains. Specifically, the test measures immediate memory, visuospatial/constructional ability, language, attention, and delayed memory. Scores from all subtests are aggregated into a total composite score. RBANS data were age-normed and analyzed as index scores (also referred to as standard scores), which have a mean of 100 and a standard deviation of 15. Higher scores on each sub measure and index indicate better performance. A negative change from baseline indicates worsening.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score
Description
The PSP-QoL is a patient-reported outcome measure developed specifically for assessing the health-related quality of life in people living with PSP. It is validated 45-item questionnaire and visual analog scale that is comprised of 2 subscales: physical health state (22 items), which covers mobility, dysarthria, dysphagia, visual disturbances, self-care, and activities of daily living, and mental health state (23 items), which covers emotional, cognitive and social functioning. Items are given a 6-reponse option format (No Problem, Slight Problem, Moderate Problem, Marked Problem, Extreme Problem and Not Applicable). The subscale results are derived by summing the respective items for that subscale and transforming the scores into a range of 0 to 100, the higher the scores indicating a greater impact of the disease on the aspect measured. The PSP-QoL also comprises of a Life Satisfaction rating gauge, which is a visual analog scale with a range of 0 (worst) to 100 (best).
Time Frame
Baseline, Week 52
Title
Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48
Description
The SEADL scale is a means of assessing a person's ability to perform daily activities in terms of speed and independence, with 100% indicating total independence, falling to 0%, which indicates a state of complete dependence. The individual is asked to rate his or her function using an 11-point scale (10% increments), from 100% (completely independent; able to do all chores without slowness, difficulty, or impairment; essentially normal; unaware of any difficulty) to 0% (vegetative functions such as swallowing, bladder and bowels are not functioning; bedridden). A negative change from baseline indicates worsening.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52
Description
The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in participants with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Phonemic Fluency Test Score at Week 48
Description
Phonemic fluency is a sensitive test for assessing frontal lobe dysfunction. Participants are given a letter of the alphabet and asked to name as many words as they can that start with that letter in 1 minute. The score for each trial is auto-calculated as follows: Trial 1: Total number of correct responses for the first letter (range 0 to 40); Trial 2: Total number of correct responses for the second letter (range 0 to 40). The total score from the two trials will be used for analysis (range 0 to 80). More number of words correlates to better phonemic fluency. A negative change from baseline indicates worsening.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Letter-Number Sequencing Test at Week 48
Description
Letter number is a test of working memory which involves ordering a series of up to 8 letters and numbers in which the numbers are repeated back first in order starting with the lowest number, then followed by the letters in alphabetical order. LNS consists of 10 items and each item has 3 trials rated as Incorrect (0) or Correct (1). The LNS total raw score (range 0 to 30) is auto-calculated by summing the 10 individual item scores (range 0 to 3 for each item). Higher number of correct items correlated to better performance and a negative change from baseline indicates worsening.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Color Trails at Week 48
Description
The Color Trails test is a language free version of the Trail Making Test and was developed to allow for broader cross cultural assessment. For Part 1 (color trails test 1), the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2 (color trails test 2), the respondent rapidly connects number circles in sequence, but alternates between pink and yellow background. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors. Less time indicates better performance. A positive change from baseline indicates worsening.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48
Description
The MOCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Scores on the MOCA range from 0-30, with higher score being better performance. A negative change from baseline indicates worsening.
Time Frame
Baseline, Week 48
Title
Number of Participants With Treatment Emergent Antibodies (Anti-BIIB092) Positive Results in Serum
Time Frame
Up to Week 48
Title
Change From Baseline of Brain Volumes as Determined by MRI at Week 52
Description
A 3 dimension (3D) T1-weighted MRI was performed to estimate brain volumes (e.g., ventricles, whole brain, midbrain, pons, superior cerebellar peduncle, third ventricle, and frontal lobes).
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Research Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Research Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-4742
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Name
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3841
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1447
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2280
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2429
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0341
Country
United States
Facility Name
Research Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
100029
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Research Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8869
Country
United States
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0394
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Research Site
City
North Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Innsbruck
State/Province
Tirol
Country
Austria
Facility Name
Research Site
City
Vienna
Country
Austria
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Bordeaux
Country
France
Facility Name
Research Site
City
Lille
Country
France
Facility Name
Research Site
City
Marseille
Country
France
Facility Name
Research Site
City
Nimes
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Rennes
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Munich
State/Province
Bavaria
Country
Germany
Facility Name
Research Site
City
Marburg
State/Province
Hessen
Country
Germany
Facility Name
Research Site
City
Rostock
State/Province
Mecklenburg-Western-Pommerania
Country
Germany
Facility Name
Research Site
City
Dusseldorf
State/Province
North Rhine-Westphalia
Country
Germany
Facility Name
Research Site
City
Dresden
State/Province
Sachsen
Country
Germany
Facility Name
Research Site
City
Kiel
State/Province
Schleswig-Holstein
Country
Germany
Facility Name
Research Site
City
Luebeck
State/Province
Schleswig-Holstein
Country
Germany
Facility Name
Research Site
City
Beelitz-Heilstatten
Country
Germany
Facility Name
Research Site
City
Bochum
Country
Germany
Facility Name
Research Site
City
Bonn
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Kassel
Country
Germany
Facility Name
Research Site
City
Ulm
Country
Germany
Facility Name
Research Site
City
Athens
State/Province
Marousi
Country
Greece
Facility Name
Research Site
City
Salerno
State/Province
Campania
Country
Italy
Facility Name
Research Site
City
Pisa
Country
Italy
Facility Name
Research Site
City
Venice Lido
Country
Italy
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Kamagaya
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Yonago
State/Province
Tottori
Country
Japan
Facility Name
Research Site
City
Shizuoka
Country
Japan
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
Research Site
City
Barakaldo
State/Province
Vizcaya
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Research Site
City
Brighton
State/Province
East Sussex
Country
United Kingdom
Facility Name
Research Site
City
Southampton
State/Province
Hampshire
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
State/Province
Merseyside
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
Country
United Kingdom
Facility Name
Research Site
City
Newport
State/Province
Wales
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34736158
Citation
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.
Results Reference
derived
PubMed Identifier
34385707
Citation
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. 2022 Oct 17;:
Results Reference
derived

Learn more about this trial

Study of BIIB092 in Participants With Progressive Supranuclear Palsy

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