Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PASSPORT)
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|ClinicalTrials.gov Identifier: NCT03068468|
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : January 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Supranuclear Palsy, Progressive||Biological: BIIB092 Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||April 24, 2017|
|Estimated Primary Completion Date :||November 8, 2019|
|Estimated Study Completion Date :||June 30, 2020|
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.
BIIB092 intravenous infusion on specified days
Other Name: BMS-986168
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.
Placebo intravenous infusion on specified days
- Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 [ Time Frame: Baseline, Week 52 ]The PSPRS is a quantitative measure of disability in participants with PSP. The PSPRS comprises 28 items in 6 areas. The available total score ranges from 0 (normal) to 100. Six items are rated on a 3-point scale (0-2) and 22 are rated on a 5-point scale (0-4) The History/Daily Activities area includes 7 items with ta total maximum of 24 points, the mentation area 4 items with 16 points, the bulbar area 2 items with 8 points, the ocular motor area 4 items with 16 points, the limb motor are 6 items with 16 points, and the gait area 5 items with 20 points.
- 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 ]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.
- 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 ]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 65, higher score indicating severe conditions.
- Clinical Global Impression of Change (CGI-C) Scale Score [ Time Frame: Week 52 ]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 Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52 [ Time Frame: Baseline, Week 52 ]The RBNAS 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.
- Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score [ Time Frame: Baseline, Week 52 ]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 5-response option format (0= no problem to 4=extreme problem). 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.
- Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48 [ Time Frame: Baseline, 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.
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52 [ Time Frame: Baseline, Week 52 ]The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients 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 [ Time Frame: Baseline, Week 48 ]Letter number is a test of working memory which involves ordering a series of up to 7 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.
- Change From Baseline in Letter-Number Sequencing Test at Week 48 [ Time Frame: Baseline, Week 48 ]Letter-number is a test of working memory which involves ordering a series of up to seven 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.
- Change From Baseline in Color Trails Test at Week 48 [ Time Frame: Baseline, 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, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 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.
- Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48 [ Time Frame: Baseline, 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.
- Number of Participants with Drug Antibodies (anti-BIIB092) in Serum [ Time Frame: Up to Week 52 ]
- Percent Change from Baseline of Brain Volumes as Determined by MRI [ Time Frame: Up to Week 52 ]A 3 dimension (3D) T1-weighted MRI will be performed to estimate brain volumes (e.g., ventricles, whole brain, midbrain, superior cerebellar peduncle, third ventricle, and frontal lobes).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068468
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068468
|Contact: US Biogen Medical Informationemail@example.com|
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|Study Director:||Medical Director||Biogen|