40 and older, any sex, with Progressive Supranuclear Palsy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total ScorePrimary· Baseline, Week 52
The PSPRS consists of 28 items grouped in six domains: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. Items are scored on a 0 to 4 scale, except for six items that are scored on a 0 to 2 scale, with the total score ranging from 0 to 100. Higher scores indicate more severe disability or movement abnormality. Positive changes in score indicate worsening from baseline.
Group
Value
95% CI
Placebo
10.5
± 0.94
ABBV-8E12 2000mg
10.5
± 0.96
ABBV-8E12 4000mg
11.4
± 0.94
Number of Participants With Adverse EventsPrimary· 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
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important
Group
Value
95% CI
Placebo
108
ABBV-8E12 2000mg
111
ABBV-8E12 4000mg
111
Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)Secondary· Baseline, Week 52
The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Positive changes in score indicate worsening from baseline.
Group
Value
95% CI
Placebo
5.6
± 0.62
ABBV-8E12 2000mg
5.8
± 0.63
ABBV-8E12 4000mg
7.0
± 0.63
Clinical Global Impression of Change (CGI-C) Score at Week 52Secondary· Week 52
The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.
Group
Value
95% CI
Placebo
5.1
± 0.11
ABBV-8E12 2000mg
5.1
± 0.11
ABBV-8E12 4000mg
5.0
± 0.11
Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)Secondary· Baseline, Week 52
Magnetic resonance imaging (MRI) of several different brain regions was performed and volumetric analysis was conducted to quantify midbrain atrophy. Negative changes in values indicate a reduction in volume.
Group
Value
95% CI
Placebo
-122.0
± 9.64
ABBV-8E12 2000mg
-129.1
± 9.69
ABBV-8E12 4000mg
-128.3
± 9.69
Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)Secondary· Baseline, Week 52
The Schwab and England Activities of Daily Living (SEADL) consists of ten items intended to evaluate the daily life activities of a participant. The SEADL is composed of two sections: the first is a self-reported questionnaire in which participants grade their own daily life activities, such as dressing, using the toilet, resting, eating, and social activities (subjective assessment), and the second is an assessment of motor functions, such as postural balance, speaking, rigidity, and tremors, conducted by a clinician (objective assessment). It is a percentage scale divided into deciles, and t
Group
Value
95% CI
Placebo
-20.6
± 1.79
ABBV-8E12 2000mg
-18.0
± 1.82
ABBV-8E12 4000mg
-20.5
± 1.77
Maximum Observed Serum Concentration (Cmax) for ABBV-8E12Secondary· First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
The maximum observed serum concentration after the first and the fifth doses in Cohort 1 and Cohort J1 was determined.
First Dosing Interval, 2 weeks, Day 1-14
Group
Value
95% CI
Cohort 1, ABBV-8E12 2000 mg
714
± 32
Cohort 1, ABBV-8E12 4000 mg
1450
± 20
Cohort J1, ABBV-8E12 2000 mg
853
± 6
Cohort J1, ABBV-8E12 4000 mg
1580
± 13
Fifth Dosing Interval, 4 weeks, Day 85-113
Group
Value
95% CI
Cohort 1, ABBV-8E12 2000 mg
1070
± 56
Cohort 1, ABBV-8E12 4000 mg
2350
± 23
Cohort J1, ABBV-8E12 2000 mg
1010
± 21
Cohort J1, ABBV-8E12 4000 mg
1960
± 15
Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12Secondary· First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax, the maximum plasma concentration. Tmax was measured after the first and the fifth doses in Cohort 1 and Cohort J1.
First Dosing Interval, 2 weeks, Day 1-14
Group
Value
95% CI
Cohort 1, ABBV-8E12 2000 mg
4.0
3.2 – 6.1
Cohort 1, ABBV-8E12 4000 mg
4.1
3.2 – 5.6
Cohort J1, ABBV-8E12 2000 mg
5.0
4.0 – 5.2
Cohort J1, ABBV-8E12 4000 mg
4.8
4.3 – 4.9
Fifth Dosing Interval, 4 weeks, Day 85-113
Group
Value
95% CI
Cohort 1, ABBV-8E12 2000 mg
3.6
2.9 – 5.5
Cohort 1, ABBV-8E12 4000 mg
4.0
3.3 – 46.2
Cohort J1, ABBV-8E12 2000 mg
5.0
4.4 – 5.7
Cohort J1, ABBV-8E12 4000 mg
3.4
3.2 – 3.5
Area Under the Concentration Time Curve (AUC) for ABBV-8E12Secondary· First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113
The area under the plasma concentration-time curve (AUC; measured in µg•day/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABBV-8E12 was estimated using non-compartmental methods after the first and the fifth doses in Cohort 1 and Cohort J1.
First Dosing Interval, 2 weeks, Day 1-14
Group
Value
95% CI
Cohort 1, ABBV-8E12 2000 mg
5070
± 25
Cohort 1, ABBV-8E12 4000 mg
10400
± 21
Cohort J1, ABBV-8E12 2000 mg
5950
± 12
Cohort J1, ABBV-8E12 4000 mg
10400
± 11
Fifth Dosing Interval, 4 weeks, Day 85-113
Group
Value
95% CI
Cohort 1, ABBV-8E12 2000 mg
13900
± 28
Cohort 1, ABBV-8E12 4000 mg
31600
± 36
Cohort J1, ABBV-8E12 2000 mg
15200
± 21
Cohort J1, ABBV-8E12 4000 mg
23900
± 15
Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)Secondary· First day of the Fifth Dosing Interval, Day 85
The concentration of ABBV-8E12 immediately prior to infusion of the fifth dose (Ctrough; measured in µg/mL) was estimated using non-compartmental methods in Cohort 1 and Cohort J1.
Group
Value
95% CI
Cohort 1, ABBV-8E12 2000 mg
353
± 27
Cohort 1, ABBV-8E12 4000 mg
657
± 45
Cohort J1, ABBV-8E12 2000 mg
345
± 32
Cohort J1, ABBV-8E12 4000 mg
595
± 16
Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) ScoreSecondary· Baseline, Week 52
The CGI-S is a clinician's rating of disease severity. The CGI-S rates severity of illness on a 7-point scale, using a range of responses from 1 (normal) through 7 (the most severely ill). This rating is based upon observed and reported symptoms, behavior, and function in the past 7 days. Positive changes in score indicate worsening from baseline.
Group
Value
95% CI
Placebo
0.6
± 0.10
ABBV-8E12 2000mg
0.6
± 0.10
ABBV-8E12 4000mg
0.6
± 0.10
Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Health Related Quality of Life Scale (PSP-QoL) Total ScoreSecondary· Baseline, Week 52
The PSP-QoL is a validated patient-reported outcome measure, specifically designed to assess the quality of life of participants with PSP. There are 45 items and two subscales: physical and mental impact. Items are scored from 0 (no problem) to 4 (extreme problems). The total subscale sum scores are linearly converted into a 0 to 100 scale, and higher scores indicate a lower quality of life. Positive changes in score indicate a decline in quality of life.
Group
Value
95% CI
Placebo
9.2
± 1.63
ABBV-8E12 2000mg
10.3
± 1.65
ABBV-8E12 4000mg
10.0
± 1.64
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected 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. In addition, serious adverse events and protocol-related nonserious adverse events were collected from the time the participant signed the study-specific informed consent..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03413319 — Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
· Phase 1
· completed
NCT03391765 — An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
· Phase 2
· terminated
NCT02880956 — A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
· Phase 2
· completed
NCT03744546 — Expanded Access to ABBV-8E12
· no longer available
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 3 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02985879.