Trial · NCT03068468
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
NCT03068468, Phase 2, Terminated, Biogen; results first posted 2020-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of BIIB092 in Participants With Progressive Supranuclear Palsy. Trials, record NCT03068468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03068468
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BIIB092 in Participants With Progressive Supranuclear Palsy
- NCT number
- NCT03068468
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 490 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Supranuclear Palsy, Progressive
- Interventions
- BIIB092, Placebo
- First posted
- 2017-03-01
- Last updated
- 2020-12-21
- Other registries' IDs
- eudract:2016-002554-21
- Results first posted
- 2020-12-21
- Limitations and caveats
- Study got terminated as the primary endpoint was not met. PC period was completed at the time of termination. The study was not terminated due to a safety concern.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 | Baseline, 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. |
| Primary | Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | 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. |
| Secondary | 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 | 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 52, higher score indicating severe conditions. A positive change from baseline indicates worsening. |
| Secondary | Clinical Global Impression of Change (CGI-C) Scale Score | 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. |
| Secondary | Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52 | Baseline, 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. |
| Secondary | Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52 | Baseline, 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. |
| Secondary | Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score | 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 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). |
| Secondary | Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48 | 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. 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. |
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52 | Baseline, 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. |
| Secondary | Change From Baseline in Phonemic Fluency Test Score at Week 48 | Baseline, 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 | Baseline, Week 52 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies number of participants who had response on Week 52. | Score on a scale | MEAN |
| PRIMARY | Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | up to 52 weeks | Safety population included all randomized participants who had received at least one dose of study treatment (BIIB092 or Placebo). Participants randomized to Placebo that received at least one dose of BIIB092 2000 mg during the placebo-controlled period will be counted in the BIIB092 2000 mg group for the safety population. Three participants who received BIIB092 in Placebo group were counted in BIIB092 200 mg group. | Percentage of participants | NUMBER |
| SECONDARY | 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 | Baseline, Week 52 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies total number of participants analyzed in this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Clinical Global Impression of Change (CGI-C) Scale Score | Week 52 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies total number of participants analyzed in this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52 | Baseline, Week 52 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies the total number of participants analyzed in this outcome measure. | z-score | MEAN |
| SECONDARY | Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52 | Baseline, Week 52 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies total number of participants analyzed in this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score | Baseline, Week 52 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies number of participants who had response on Week 52. 'Number Analyzed' signifies the number of participants who were evaluated for the specified parameter. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48 | Baseline, Week 48 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies total number of participants analyzed in this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52 | Baseline, Week 52 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies total number of participants analyzed in this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Phonemic Fluency Test Score at Week 48 | Baseline, Week 48 | ITT population included randomized participants who had received at least 1 dose of blinded study treatment (BIIB092 or Placebo). 'Number of Participants Analyzed' signifies total number of participants analyzed in this outcome measure. | Score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 | Placebo (PC Period) | PSPRS: 28 items | 10.6 | Standard Error 0.8 | Score on a scale |
| Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 | BIIB092 2000 mg (PC Period) | PSPRS: 28 items | 10.4 | Standard Error 0.6 | Score on a scale |
| Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 | Placebo (PC Period) | PSPRS: 15 items | 7.57 | Standard Error 0.52 | Score on a scale |
| Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52 | BIIB092 2000 mg (PC Period) | PSPRS: 15 items | 7.29 | Standard Error 0.38 | Score on a scale |
| Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | Placebo (PC Period) | Death | 4.9 | Percentage of participants | |
| Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | BIIB092 2000 mg (PC Period) | Death | 4.9 | Percentage of participants | |
| Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | Placebo (PC Period) | SAEs | 32.1 | Percentage of participants | |
| Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | BIIB092 2000 mg (PC Period) | SAEs | 27.2 | Percentage of participants | |
| Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | Placebo (PC Period) | AEs | 93.2 | Percentage of participants | |
| Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug | BIIB092 2000 mg (PC Period) | AEs | 92.9 | Percentage of participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-Controlled Period | STARTED | Placebo (PC Period) | 166 | |
| Placebo-Controlled Period | STARTED | BIIB092 2000 mg (PC Period) | 324 | |
| Placebo-Controlled Period | STARTED | BIIB092 Late Start (OLE Period) | 0 | |
| Placebo-Controlled Period | STARTED | BIIB092 Early Start (OLE Period) | 0 | |
| Placebo-Controlled Period | Treated | Placebo (PC Period) | 165 | |
| Placebo-Controlled Period | Treated | BIIB092 2000 mg (PC Period) | 321 | |
| Placebo-Controlled Period | Treated | BIIB092 Late Start (OLE Period) | 0 | |
| Placebo-Controlled Period | Treated | BIIB092 Early Start (OLE Period) | 0 | |
| Placebo-Controlled Period | COMPLETED | Placebo (PC Period) | 144 | |
| Placebo-Controlled Period | COMPLETED | BIIB092 2000 mg (PC Period) | 279 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events792
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo (Placebo Controlled Period) | 15 | 162 | |
| other | Constipation | Gastrointestinal disorders | BIIB092 2000 mg (Placebo Controlled Period) | 36 | 324 | |
| other | Constipation | Gastrointestinal disorders | BIIB092 Late Start (Open-label Extension Period) | 4 | 137 | |
| other | Constipation | Gastrointestinal disorders | BIIB092 Early Start (Open-label Extension Period) | 16 | 279 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Placebo Controlled Period) | 9 | 162 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB092 2000 mg (Placebo Controlled Period) | 23 | 324 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB092 Late Start (Open-label Extension Period) | 4 | 137 | |
| other | Diarrhoea | Gastrointestinal disorders | BIIB092 Early Start (Open-label Extension Period) | 9 | 279 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Placebo Controlled Period) | 14 | 162 | |
| other | Nasopharyngitis | Infections and infestations | BIIB092 2000 mg (Placebo Controlled Period) | 28 | 324 |
1 to 10 of 792Source ClinicalTrials.gov
See all 792 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Placebo Controlled Period) | 8 | 162 |
| Total, all-cause mortality | BIIB092 2000 mg (Placebo Controlled Period) | 16 | 324 |
| Total, all-cause mortality | BIIB092 Late Start (Open-label Extension Period) | 10 | 137 |
| Total, all-cause mortality | BIIB092 Early Start (Open-label Extension Period) | 16 | 279 |
| Total, other adverse events | Placebo (Placebo Controlled Period) | 127 | 162 |
| Total, other adverse events | BIIB092 2000 mg (Placebo Controlled Period) | 235 | 324 |
| Total, other adverse events | BIIB092 Late Start (Open-label Extension Period) | 69 | 137 |
| Total, other adverse events | BIIB092 Early Start (Open-label Extension Period) | 130 | 279 |
| Total, serious adverse events | Placebo (Placebo Controlled Period) | 52 | 162 |
| Total, serious adverse events | BIIB092 2000 mg (Placebo Controlled Period) | 88 | 324 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BIIB092 2000 mg (PC Period) vs Placebo (PC Period): Number of Participants With Treatment Emergent Antibodies (Anti-BIIB092) Positive Results in Serum |
Source Trial comparisons
Tests5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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