TerminatedPhase 2Results posted

A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

Lead sponsor

AbbVie

Asset

Tilavonemab

Listed sites

Recruiting sites

Enrollment

378

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoints

•Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score•Adverse Events

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 number2016-001635-12

Org study IDM15-562

NCT IDNCT02985879

Timeline

Milestones

Study first posted2016-12-07estimated

Study start2016-12-12actual

Primary completion2019-11-20actual

Study completion2019-11-20actual

Last update posted2021-02-03actual

Results first posted2021-02-03actual

Assets

Drug assets

Tilavonemab

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

•Male or female participant with age 40 years or greater at the time of signed consent

•Meets the criteria for possible or probable progressive supranuclear palsy (PSP; Steele-Richardson-Olszewski Syndrome)

•Presence of PSP symptoms for less than 5 years

•Participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker)

•Participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)

Exclusion criteria

•Participants who weigh less than 44 kg (97 lbs) at screening

•Mini-Mental State Examination (MMSE) score less than 15 at screening

•Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

•Participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period

•Evidence of any clinically significant neurological disorder other than PSP

•The participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10) criteria

•Participant has had a significant illness or infection requiring medical intervention in the past 30 days

Endpoints (38)

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

Neuroimaging

Behavior / neuropsychiatric

Safety / tolerability / PK

Function / daily living

Caregiver / quality of life

Other clinical outcomes

Other (unclassified)

Function / daily living

4 endpoints

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=63 Participants	5.6	0.62
ABBV-8E12 2000mgn=60 Participants	5.8	0.63
ABBV-8E12 4000mgn=60 Participants	7.0	0.63

LS Mean Difference0.295% CI-1.52 - 1.93p=0.812Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference1.495% CI-0.30 - 3.16p=0.104Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of independence	Standard error
Placebon=58 Participants	-20.6	1.79
ABBV-8E12 2000mgn=56 Participants	-18.0	1.82
ABBV-8E12 4000mgn=60 Participants	-20.5	1.77

LS Mean Difference2.595% CI-2.48 - 7.51p=0.323Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference0.195% CI-4.86 - 5.02p=0.974Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Behavior / neuropsychiatric

8 endpoints

Primary/protocol endpoint

Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score

Time frame:Baseline, Week 52

change from baseline, improvement

Primary/registry result

Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=59 Participants	10.5	0.94
ABBV-8E12 2000mgn=56 Participants	10.5	0.96
ABBV-8E12 4000mgn=59 Participants	11.4	0.94

LS Mean Difference0.095% CI-2.63 - 2.63p=0.998Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference1.095% CI-1.63 - 3.58p=0.464Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/protocol endpoint

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

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26

Time frame:From Baseline to Week 52

time to event, event

Secondary/registry result

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

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=50 Participants	0.6	0.10
ABBV-8E12 2000mgn=48 Participants	0.6	0.10
ABBV-8E12 4000mgn=51 Participants	0.6	0.10

LS Mean Difference-0.095% CI-0.31 - 0.23p=0.761Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference-0.195% CI-0.32 - 0.21p=0.678Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=59 Participants	0.8	0.24
ABBV-8E12 2000mgn=57 Participants	0.9	0.24
ABBV-8E12 4000mgn=59 Participants	1.0	0.24

LS Mean Difference0.195% CI-0.60 - 0.74p=0.828Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference0.295% CI-0.46 - 0.87p=0.543Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Time to Loss of Ability to Walk Independently as Measured by Progressive Supranuclear Palsy Rating Scale (PSPRS) Item 26

Time frame:From Baseline to Week 52

time to event, event

Posted result

Group	Value (median), days	Reported bounds
Placebon=126 Participants	169.0	-89.0 - 255.0
ABBV-8E12 2000 mgn=126 Participants	170.0	-87.0 - 253.0
ABBV-8E12 4000 mgn=125 Participants	203.0	-169.0 - 255.0

Neuroimaging

12 endpoints

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm^3	Standard error
Placebon=53 Participants	-122.0	9.64
ABBV-8E12 2000mgn=55 Participants	-129.1	9.69
ABBV-8E12 4000mgn=54 Participants	-128.3	9.69

LS Mean Difference-7.295% CI-33.86 - 19.53p=0.597Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference-6.395% CI-33.04 - 20.42p=0.642Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm^3	Standard error
Placebon=54 Participants	157.9	18.27
ABBV-8E12 2000mgn=58 Participants	152.4	18.04
ABBV-8E12 4000mgn=53 Participants	125.0	18.57

LS Mean Difference-5.595% CI-55.66 - 44.63p=0.829Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference-32.995% CI-83.94 - 18.23p=0.206Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Mean Change From Baseline to Week 52 in Superior Cerebellar Peduncle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm^3	Standard error
Placebon=51 Participants	-8.3	2.78
ABBV-8E12 2000mgn=55 Participants	-4.3	2.74
ABBV-8E12 4000mgn=54 Participants	-3.7	2.74

LS Mean Difference4.095% CI-3.65 - 11.65p=0.304Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference4.595% CI-3.11 - 12.19p=0.243Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm^3	Standard error
Placebon=48 Participants	-374.5	38.42
ABBV-8E12 2000mgn=49 Participants	-400.9	38.60
ABBV-8E12 4000mgn=43 Participants	-341.3	40.61

LS Mean Difference-26.495% CI-132.76 - 79.94p0.625Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference33.295% CI-76.34 - 142.71p=0.550Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm^3	Standard error
Placebon=45 Participants	-22496.2	1793.36
ABBV-8E12 2000mgn=46 Participants	-20757.1	1783.00
ABBV-8E12 4000mgn=49 Participants	-18811.3	1740.72

LS Mean Difference1739.195% CI-3201.75 - 6680.02p=0.488Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference3684.995% CI-1225.46 - 8595.29p=0.140Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Secondary/registry result

Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm^3	Standard error
Placebon=48 Participants	1052.6	425.55
ABBV-8E12 2000mgn=49 Participants	1260.5	423.96
ABBV-8E12 4000mgn=43 Participants	1186.1	445.18

LS Mean Difference207.995% CI-962.98 - 1378.88p=0.726Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference133.695% CI-1075.26 - 1342.40p=0.828Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total Score

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=62 Participants	9.2	1.63
ABBV-8E12 2000mgn=59 Participants	10.3	1.65
ABBV-8E12 4000mgn=60 Participants	10.0	1.64

LS Mean Difference1.095% CI-3.50 - 5.57p=0.653Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference1.095% CI-3.50 - 5.57p=0.748Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events

Time frame:From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks

event count, event

Primary/registry result

Number of Participants With Adverse Events

Time frame:From the first dose of study drug until 20 weeks following discontinuation of study drug administration have elapsed (approximately 5 half-lives), up to 80 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebon=126 Participants	108	-
ABBV-8E12 2000mgn=126 Participants	111	-
ABBV-8E12 4000mgn=125 Participants	111	-

Secondary/protocol endpoint

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12

Time frame:First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

concentration, descriptive

Secondary/protocol endpoint

Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12

Time frame:First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

time to event, event

Secondary/protocol endpoint

Area Under the Concentration Time Curve (AUC) for ABBV-8E12

Time frame:First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

concentration, descriptive

Secondary/registry result

Maximum Observed Serum Concentration (Cmax) for ABBV-8E12

Time frame:First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

concentration, descriptive

Posted result

Group	Value (geometric_mean), µg/mL	Geometric coefficient of variation
Cohort 1, ABBV-8E12 2000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=11 Participants	714	32
Fifth Dosing Interval, 4 weeks, Day 85-113n=9 Participants	1070	56
Cohort 1, ABBV-8E12 4000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=9 Participants	1450	20
Fifth Dosing Interval, 4 weeks, Day 85-113n=7 Participants	2350	23
Cohort J1, ABBV-8E12 2000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=3 Participants	853	6
Fifth Dosing Interval, 4 weeks, Day 85-113n=2 Participants	1010	21
Cohort J1, ABBV-8E12 4000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=3 Participants	1580	13
Fifth Dosing Interval, 4 weeks, Day 85-113n=2 Participants	1960	15

Secondary/registry result

Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12

Time frame:First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

time to event, event

Posted result

Group	Value (median), hours	Reported bounds
Cohort 1, ABBV-8E12 2000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=11 Participants	4.0	-3.2 - 6.1
Fifth Dosing Interval, 4 weeks, Day 85-113n=9 Participants	3.6	-2.9 - 5.5
Cohort 1, ABBV-8E12 4000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=9 Participants	4.1	-3.2 - 5.6
Fifth Dosing Interval, 4 weeks, Day 85-113n=7 Participants	4.0	-3.3 - 46.2
Cohort J1, ABBV-8E12 2000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=3 Participants	5.0	-4.0 - 5.2
Fifth Dosing Interval, 4 weeks, Day 85-113n=2 Participants	5.0	-4.4 - 5.7
Cohort J1, ABBV-8E12 4000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=3 Participants	4.8	-4.3 - 4.9
Fifth Dosing Interval, 4 weeks, Day 85-113n=2 Participants	3.4	-3.2 - 3.5

Secondary/registry result

Area Under the Concentration Time Curve (AUC) for ABBV-8E12

Time frame:First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113

concentration, descriptive

Posted result

Group	Value (geometric_mean), µg•day/mL	Geometric coefficient of variation
Cohort 1, ABBV-8E12 2000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=11 Participants	5070	25
Fifth Dosing Interval, 4 weeks, Day 85-113n=10 Participants	13900	28
Cohort 1, ABBV-8E12 4000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=9 Participants	10400	21
Fifth Dosing Interval, 4 weeks, Day 85-113n=8 Participants	31600	36
Cohort J1, ABBV-8E12 2000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=3 Participants	5950	12
Fifth Dosing Interval, 4 weeks, Day 85-113n=3 Participants	15200	21
Cohort J1, ABBV-8E12 4000 mgFirst Dosing Interval, 2 weeks, Day 1-14n=3 Participants	10400	11
Fifth Dosing Interval, 4 weeks, Day 85-113n=3 Participants	23900	15

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Clinical Global Impression of Change (CGI-C) Score at Week 52

Time frame:Week 52

descriptive

Secondary/registry result

Clinical Global Impression of Change (CGI-C) Score at Week 52

Time frame:Week 52

descriptive

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Placebon=50 Participants	5.1	0.11
ABBV-8E12 2000mgn=48 Participants	5.1	0.11
ABBV-8E12 4000mgn=51 Participants	5.0	0.11

LS Mean Difference-0.095% CI-0.36 - 0.26p=0.756Mixed-effects model, repeated measures

ABBV-8E12 2000 mg vs Placebo

LS Mean Difference-0.195% CI-0.44 - 0.18p=0.409Mixed-effects model, repeated measures

ABBV-8E12 4000 mg vs Placebo

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)

Time frame:First day of the Fifth Dosing Interval, Day 85

concentration, descriptive

Secondary/registry result/low confidence

Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)

Time frame:First day of the Fifth Dosing Interval, Day 85

concentration, descriptive

Posted result

Group	Value (geometric_mean), µg/mL	Geometric coefficient of variation
Cohort 1, ABBV-8E12 2000 mgn=10 Participants	353	27
Cohort 1, ABBV-8E12 4000 mgn=8 Participants	657	45
Cohort J1, ABBV-8E12 2000 mgn=3 Participants	345	32
Cohort J1, ABBV-8E12 4000 mgn=3 Participants	595	16

Publications (1)

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

Hoglinger GU, Litvan I, Mendonca N, Wang D, Zheng H, Rendenbach-Mueller B, Lon HK, Jin Z, Fisseha N, Budur K, Gold M, Ryman D, Florian H; Arise Investigators. Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. Lancet Neurol. 2021 Mar;20(3):182-192. doi: 10.1016/S1474-4422(20)30489-0.
PMID33609476via DERIVED

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.