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TerminatedPhase 2Results posted

An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)

Lead sponsor

AbbVie

Asset

Tilavonemab

Listed sites

Recruiting sites

Enrollment

142

actual

Study population

Frontotemporal dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score

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 number2017-001590-16

Org study IDM15-563

NCT IDNCT03391765

Timeline

Milestones

Study first posted2018-01-05actual

Study start2018-01-24actual

Primary completion2019-12-13actual

Study completion2019-12-13actual

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

•Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)

•In the opinion of the investigator, the participant was compliant during participation in Study M15-562 (NCT02985879)

•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 the time of study entry

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

•Participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results

•More than 8 weeks have elapsed since the participant received his/her last dose of study drug in Study M15-562 (NCT02985879)

•Participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations

Endpoints (16)

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

Behavior / neuropsychiatric

Function / daily living

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 (mean), units on a scale	Standard deviation
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgn=9 Participants	6.9	4.37
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgn=6 Participants	3.2	5.27
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgn=7 Participants	5.6	5.68
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgn=6 Participants	7.3	6.28

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 (mean), units on a scale	Standard deviation
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgn=9 Participants	-13.3	14.14
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgn=6 Participants	-13.3	12.11
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgn=7 Participants	-10.0	14.14
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgn=5 Participants	-18.0	13.04

Behavior / neuropsychiatric

8 endpoints

Primary/protocol endpoint

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

Time frame:Baseline, Week 52

change from baseline, improvement

Primary/registry result

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

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgn=9 Participants	14.4	7.73
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgn=6 Participants	2.3	11.99
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgn=7 Participants	13.1	6.87
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgn=6 Participants	4.2	6.40

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 (mean), units on a scale	Standard deviation
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgn=8 Participants	0.6	0.52
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgn=6 Participants	1.3	0.82
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgn=7 Participants	1.3	0.49
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgn=5 Participants	0.6	1.82

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 (mean), units on a scale	Standard deviation
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgn=9 Participants	2.4	1.74
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgn=6 Participants	-0.2	2.23
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgn=7 Participants	2.0	2.83
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgn=6 Participants	1.0	2.10

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
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgn=51 Participants	84.0	-29.0 - 86.0
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgn=45 Participants	85.0	-84.0 - 91.0
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgn=23 Participants	85.0	-42.0 - 91.0
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgn=23 Participants	84.0	-64.0 - 86.0

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgBaseline of M15-563n=50 Participants	5.0	0.89
Week 52 of M15-563n=8 Participants	5.1	0.64
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgBaseline of M15-563n=42 Participants	4.8	0.92
Week 52 of M15-563n=6 Participants	5.2	0.98
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgBaseline of M15-563n=22 Participants	4.9	0.92
Week 52 of M15-563n=7 Participants	5.9	0.90
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgBaseline of M15-563n=23 Participants	5.0	0.91
Week 52 of M15-563n=5 Participants	5.4	1.14

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/registry result/low confidence

Patient Global Impression of Change Score (PGI-C) Score From Baseline to Week 52

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
M15-562 ABBV-8E12 2000 mg/M15-563 ABBV-8E12 2000 mgBaseline of M15-563n=48 Participants	5.0	1.03
Week 52 of M15-563n=9 Participants	4.9	1.62
M15-562 ABBV-8E12 4000 mg/M15-563 ABBV-8E12 4000 mgBaseline of M15-563n=43 Participants	5.1	1.04
Week 52 of M15-563n=6 Participants	4.7	1.51
M15-562 Placebo/M15-563 ABBV-8E12 2000 mgBaseline of M15-563n=23 Participants	5.2	1.30
Week 52 of M15-563n=7 Participants	5.4	0.53
M15-562 Placebo/M15-563 ABBV-8E12 4000 mgBaseline of M15-563n=23 Participants	5.3	1.15
Week 52 of M15-563n=6 Participants	5.3	1.37

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.