Trial · NCT02985879

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

NCT02985879, Phase 2, Terminated, AbbVie; results first posted 2021-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP). Trials, record NCT02985879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02985879

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
NCT number: NCT02985879
Status: Terminated
Phases: Phase 2
Enrollment: 378 participants, actual
Lead sponsor: AbbVie
Conditions: Progressive Supranuclear Palsy
Interventions: Placebo, ABBV-8E12
First posted: 2016-12-07
Last updated: 2021-02-03
Other registries' IDs: eudract:2016-001635-12
Results first posted: 2021-02-03

Source ClinicalTrials.gov

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score	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.
Primary	Number of Participants With Adverse Events	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 medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity from first dose of study drug until 20 weeks after the last dose. For more details on AEs please see the Adverse Event section.
Secondary	Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)	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.
Secondary	Clinical Global Impression of Change (CGI-C) Score at Week 52	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.
Secondary	Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	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.
Secondary	Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)	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 the results are reported between 0% (bedridden) and 100% (healthy). Negative changes in values indicate a decline in health.
Secondary	Maximum Observed Serum Concentration (Cmax) for ABBV-8E12	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.
Secondary	Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12	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.
Secondary	Area Under the Concentration Time Curve (AUC) for ABBV-8E12	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.
Secondary	Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)	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.

1 to 10 of 19Source ClinicalTrials.gov

See all 19 registered outcomes

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score	Baseline, Week 52	ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Number of Participants With Adverse Events	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	Safety Dataset: all randomized participants who received at least one dose of study drug	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)	Baseline, Week 52	ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression of Change (CGI-C) Score at Week 52	Week 52	ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at Week 52	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI)	Baseline, Week 52	ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52	mm^3	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL)	Baseline, Week 52	ITT dataset: all randomized participants who received at least one dose of study drug and those with available data at baseline and at Week 52	percentage of independence	LEAST_SQUARES_MEAN
SECONDARY	Maximum Observed Serum Concentration (Cmax) for ABBV-8E12	First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113	Participants in Cohort 1 and Cohort J1 with available data	µg/mL	GEOMETRIC_MEAN
SECONDARY	Time to Maximum Observed Serum Concentration (Tmax) for ABBV-8E12	First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113	Participants in Cohort 1 and Cohort J1 with available data	hours	MEDIAN
SECONDARY	Area Under the Concentration Time Curve (AUC) for ABBV-8E12	First Dosing Interval, 2 weeks, Day 1-14; Fifth Dosing Interval, 4 weeks, Day 85-113	Participants in Cohort 1 and Cohort J1 with available data	µg•day/mL	GEOMETRIC_MEAN
SECONDARY	Serum Concentration of ABBV-8E12 Prior to Infusion of a Day of Dosing (Ctrough)	First day of the Fifth Dosing Interval, Day 85	Participants in Cohort 1 and Cohort J1 with available data	µg/mL	GEOMETRIC_MEAN

1 to 10 of 19Source ClinicalTrials.gov

See all 19 outcomes

Results by group73

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score	Placebo	10.5	Standard Error 0.94	units on a scale
Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score	ABBV-8E12 2000mg	10.5	Standard Error 0.96	units on a scale
Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score	ABBV-8E12 4000mg	11.4	Standard Error 0.94	units on a scale
Number of Participants With Adverse Events	Placebo	108		Participants
Number of Participants With Adverse Events	ABBV-8E12 2000mg	111		Participants
Number of Participants With Adverse Events	ABBV-8E12 4000mg	111		Participants
Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)	Placebo	5.6	Standard Error 0.62	units on a scale
Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)	ABBV-8E12 2000mg	5.8	Standard Error 0.63	units on a scale
Mean Change From Baseline to Week 52 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)	ABBV-8E12 4000mg	7.0	Standard Error 0.63	units on a scale
Clinical Global Impression of Change (CGI-C) Score at Week 52	Placebo	5.1	Standard Error 0.11	units on a scale

1 to 10 of 73Source ClinicalTrials.gov

See all 73 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	126
Overall Study	STARTED	ABBV-8E12 2000mg	127
Overall Study	STARTED	ABBV-8E12 4000mg	125
Overall Study	COMPLETED	Placebo	50
Overall Study	COMPLETED	ABBV-8E12 2000mg	52
Overall Study	COMPLETED	ABBV-8E12 4000mg	48
Overall Study	NOT COMPLETED	Placebo	76
Overall Study	NOT COMPLETED	ABBV-8E12 2000mg	75
Overall Study	NOT COMPLETED	ABBV-8E12 4000mg	77

Source ClinicalTrials.gov

Adverse events390

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	7	126	7
other	CONSTIPATION	Gastrointestinal disorders	ABBV-8E12 2000mg	9	126	12
other	CONSTIPATION	Gastrointestinal disorders	ABBV-8E12 4000mg	6	125	6
other	DIARRHOEA	Gastrointestinal disorders	Placebo	6	126	6
other	DIARRHOEA	Gastrointestinal disorders	ABBV-8E12 2000mg	10	126	10
other	DIARRHOEA	Gastrointestinal disorders	ABBV-8E12 4000mg	8	125	10
other	FATIGUE	General disorders	Placebo	2	126	9
other	FATIGUE	General disorders	ABBV-8E12 2000mg	9	126	19
other	FATIGUE	General disorders	ABBV-8E12 4000mg	4	125	4
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Placebo	8	126	9

1 to 10 of 390Source ClinicalTrials.gov

See all 390 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	8	126
Total, all-cause mortality	ABBV-8E12 2000mg	9	126
Total, all-cause mortality	ABBV-8E12 4000mg	9	125
Total, other adverse events	Placebo	83	126
Total, other adverse events	ABBV-8E12 2000mg	75	126
Total, other adverse events	ABBV-8E12 4000mg	80	125
Total, serious adverse events	Placebo	33	126
Total, serious adverse events	ABBV-8E12 2000mg	29	126
Total, serious adverse events	ABBV-8E12 4000mg	34	125

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33609476	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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