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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT02985879
• Date of registration: 01/12/2016
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy
• Date of first enrolment: December 12, 2016
• Target sample size: 378
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02985879
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, France, Germany, Italy, Japan, Spain, United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion 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)

Key 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



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Supranuclear Palsy

Intervention(s)

Drug: Placebo

Drug: ABBV-8E12

Primary Outcome(s)

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]

Change From Baseline to Week 52 in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score [Time Frame: Baseline, Week 52]

Secondary Outcome(s)

Mean Change From Baseline to Week 52 in Whole Brain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) [Time Frame: Baseline, Week 52]

Mean Change From Baseline to Week 52 in Third Ventricle Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) [Time Frame: Baseline, Week 52]

Mean Change From Baseline to Week 52 in Midbrain Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) [Time Frame: Baseline, Week 52]

Clinical Global Impression of Change (CGI-C) Score at Week 52 [Time Frame: Week 52]

Mean Change From Baseline to Week 52 in Brainstem Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) [Time Frame: Baseline, Week 52]

Mean Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale (SEADL) [Time Frame: Baseline, Week 52]

Mean Change From Baseline to Week 52 in Frontal Lobe Atrophy As Measured by Volumetric Magnetic Resonance Imaging (MRI) [Time Frame: Baseline, Week 52]

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]

Mean Change From Baseline to Week 52 in Progressive Supranuclear Palsy Staging System Score (PSP-SS) Score [Time Frame: Baseline, Week 52]

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]

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]

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]

Mean Change From Baseline to Week 52 in Clinical Global Impression of Severity (CGI-S) Score [Time Frame: Baseline, Week 52]

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]

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]

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]

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]

Secondary ID(s)

M15-562

2016-001635-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/02/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02985879