PASSPORT

TerminatedPhase 2Results posted

Study of BIIB092 in Participants With Progressive Supranuclear Palsy

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

Lead sponsor

Biogen

Asset

Gosuranemab

Listed sites

Recruiting sites

Enrollment

490

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Progressive Supranuclear Palsy Rating Scale (PSPRS)•Death, Serious Adverse Events (SAEs), Adverse Events (AEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2016-002554-21

Org study ID251PP301

Secondary IDCN002-012Briston-Myers Squibb

NCT IDNCT03068468

Timeline

Milestones

Study first posted2017-03-01actual

Study start2017-06-01actual

Primary completion2019-09-06actual

Study completion2020-02-07actual

Last update posted2020-12-21actual

Results first posted2020-12-21actual

Assets

Drug assets

Gosuranemab

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age41 Years

Maximum age86 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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

Endpoints (30)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Executive function / language

Function / daily living

Other clinical outcomes

Memory

Neuroimaging

Safety / tolerability / PK

Global cognition

6 endpoints

Secondary/protocol endpoint

Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48

Time frame:Baseline, Week 48

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Progressive Supranuclear Palsy (PSP)-Cognitive Composite Battery Z-Score at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), z-score	Standard error
Placebo (PC Period)n=134 Participants	-0.283	0.032
BIIB092 2000 mg (PC Period)n=249 Participants	-0.245	0.024

Difference0.03895% CI-0.036 - 0.112p0.3180MMRM

Secondary/registry result

Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) Scale at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)n=111 Participants	-3.1	0.7
BIIB092 2000 mg (PC Period)n=222 Participants	-3.2	0.5

Difference-0.295% CI-1.8 - 1.4p0.8270MMRM

Secondary/registry result

Change From Baseline in Montreal Cognitive Assessment (MoCA) Score at Week 48

Time frame:Baseline, Week 48

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)n=136 Participants	-1.0	0.3
BIIB092 2000 mg (PC Period)n=264 Participants	-0.5	0.2

Difference0.595% CI-0.2 - 1.2p0.1763MMRM

Memory

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Letter-Number Sequencing Test at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/registry result

Change From Baseline in Letter-Number Sequencing Test at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)n=139 Participants	-1.9	0.4
BIIB092 2000 mg (PC Period)n=271 Participants	-1.1	0.3

Difference0.995% CI0.0 - 1.7p0.0387MMRM

Executive function / language

4 endpoints

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Color Trails at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/registry result

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

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)n=143 Participants	6.7	0.6
BIIB092 2000 mg (PC Period)n=270 Participants	7.0	0.4

Difference0.495% CI-1.0 - 1.7p0.6031MMRM

Secondary/registry result

Change From Baseline in Color Trails at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), Seconds	Standard error
Placebo (PC Period)Color Trails Test 1n=143 Participants	16.8	3.6
Color Trails Test 2n=143 Participants	10.6	2.4
BIIB092 2000 mg (PC Period)Color Trails Test 1n=279 Participants	16.9	2.7
Color Trails Test 2n=279 Participants	10.5	1.8

Difference0.195% CI-8.1 - 8.3p0.9815MMRM

Difference-0.095% CI-5.7 - 5.6p0.9869MMRM

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/registry result

Change From Baseline in Progressive Supranuclear Palsy Quality of Life Scale (PSP-QoL) Score

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)Physical Scale Scoren=142 Participants	11.3	1.5
Mental Scale Scoren=140 Participants	5.6	1.4
Satisfaction With Your Life Todayn=141 Participants	-3.7	1.8
BIIB092 2000 mg (PC Period)Physical Scale Scoren=264 Participants	11.2	1.1
Mental Scale Scoren=264 Participants	6.1	1.0
Satisfaction With Your Life Todayn=264 Participants	-5.4	1.3

Difference-0.295% CI-3.6 - 3.3p0.9304MMRM

Difference0.595% CI-2.8 - 3.7p0.7859MMRM

Difference-1.795% CI-5.8 - 2.5p0.4297MMRM

Secondary/registry result

Change From Baseline in Schwab and England Activities of Daily Living (SEADL) Scale Score at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)n=140 Participants	-13.7	1.4
BIIB092 2000 mg (PC Period)n=277 Participants	-11.7	1.0

Difference2.095% CI-1.1 - 5.2p0.2084MMRM

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Change From Baseline of Brain Volumes as Determined by MRI at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result

Change From Baseline of Brain Volumes as Determined by MRI at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Cubic centimeter (cm^3)	Standard error
Placebo (PC Period)Ventricles Volume: Change at Week 52n=103 Participants	3.823	0.302
Whole Brain Volume: Change at Week 52n=101 Participants	-18.612	1.296
Midbrain Volume: Change at Week 52n=108 Participants	-0.116	0.008
Pons Volume: Change at Week 52n=100 Participants	-0.198	0.017
Cerebellar Peduncle Volume: Change at Week 52n=101 Participants	-0.005	0.002
Third Ventricle Volume: Change at Week 52n=114 Participants	0.140	0.014
Frontal Lobe Volume: Change at Week 52n=89 Participants	1.184	0.279
BIIB092 2000 mg (PC Period)Ventricles Volume: Change at Week 52n=222 Participants	3.802	0.216
Whole Brain Volume: Change at Week 52n=210 Participants	-19.126	0.950
Midbrain Volume: Change at Week 52n=224 Participants	-0.120	0.006
Pons Volume: Change at Week 52n=223 Participants	-0.198	0.012
Cerebellar Peduncle Volume: Change at Week 52n=216 Participants	-0.004	0.002
Third Ventricle Volume: Change at Week 52n=238 Participants	0.146	0.010
Frontal Lobe Volume: Change at Week 52n=178 Participants	1.143	0.205

Difference-0.02195% CI-0.726 - 0.684p0.9527MMRM

Difference-0.51495% CI-3.506 - 2.478p0.7357MMRM

Difference-0.00495% CI-0.023 - 0.014p0.6439MMRM

Difference0.00095% CI-0.039 - 0.040p0.9864MMRM

Difference0.00195% CI-0.004 - 0.006p0.7529MMRM

Difference0.00695% CI-0.025 - 0.038p0.6850MMRM

Difference-0.04195% CI-0.680 - 0.598p0.9000MMRM

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug

Time frame:up to 52 weeks

threshold achievement, event

Primary/registry result

Percentage of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) and Adverse Events (AEs) Leading to Discontinuation of Drug

Time frame:up to 52 weeks

threshold achievement, event

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Placebo (PC Period)Deathn=162 Participants	4.9	-
SAEsn=162 Participants	32.1	-
AEsn=162 Participants	93.2	-
AEs Leading to Discontinuation of Drugn=162 Participants	11.1	-
BIIB092 2000 mg (PC Period)Deathn=324 Participants	4.9	-
SAEsn=324 Participants	27.2	-
AEsn=324 Participants	92.9	-
AEs Leading to Discontinuation of Drugn=324 Participants	7.4	-

Other clinical outcomes

4 endpoints

Secondary/protocol endpoint

Clinical Global Impression of Change (CGI-C) Scale Score

Time frame:Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result

Clinical Global Impression of Change (CGI-C) Scale Score

Time frame:Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)n=138 Participants	5.3	0.1
BIIB092 2000 mg (PC Period)n=271 Participants	5.2	0.1

Difference-0.095% CI-0.2 - 0.1p0.7743MMRM

Secondary/registry result

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)n=140 Participants	0.6	0.1
BIIB092 2000 mg (PC Period)n=269 Participants	0.6	0.0

Difference-0.095% CI-0.2 - 0.1p0.5701MMRM

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Primary/registry result/low confidence

Change From Baseline in Progressive Supranuclear Palsy Rating Scale (PSPRS) at Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard error
Placebo (PC Period)PSPRS: 28 itemsn=139 Participants	10.6	0.8
PSPRS: 15 itemsn=139 Participants	7.57	0.52
BIIB092 2000 mg (PC Period)PSPRS: 28 itemsn=278 Participants	10.4	0.6
PSPRS: 15 itemsn=278 Participants	7.29	0.38

Difference-0.295% CI-2.0 - 1.6p0.8483Mixed model for repeated measures (MMRM)

Difference-0.2895% CI-1.50 - 0.94p0.6503MMRM

Secondary/protocol endpoint/low confidence

Change From Baseline in Phonemic Fluency Test Score at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants With Treatment Emergent Antibodies (Anti-BIIB092) Positive Results in Serum

Time frame:Up to Week 48

event count, event

Secondary/registry result/low confidence

Change From Baseline in Phonemic Fluency Test Score at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
Placebo (PC Period)n=141 Participants	-0.9	0.4
BIIB092 2000 mg (PC Period)n=273 Participants	0.0	0.3

Difference0.995% CI-0.0 - 1.8p0.0517MMRM

Secondary/registry result/low confidence

Number of Participants With Treatment Emergent Antibodies (Anti-BIIB092) Positive Results in Serum

Time frame:Up to Week 48

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo (PC Period)n=160 Participants	7	-
BIIB092 2000 mg (PC Period)n=323 Participants	0	-

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.