Session Information
Date: Sunday, October 7, 2018
Session Title: Parkinsonism, MSA, PSP (Secondary and Parkinsonism-Plus)
Session Time: 1:45pm-3:15pm
Location: Hall 3FG
Objective: This double-blind, placebo-controlled phase 2 study (M15-562 ARISE study, NCT02985879) assesses the safety and efficacy of ABBV-8E12 treatment in patients with progressive supranuclear palsy (PSP) for 52 weeks.
Background: ABBV-8E12 is a humanized anti-tau monoclonal antibody being developed for the treatment of PSP and early Alzheimer’s disease (AD). A phase 1 double-blind, placebo-controlled, single ascending dose study on the safety, tolerability, and pharmacokinetics of ABBV-8E12 in PSP patients (NCT02494024) was recently completed. The phase 1 results showed that ABBV-8E12, when administered as a single dose up to 50 mg/kg, exhibited an acceptable safety and tolerability profile to support repeat-dose testing in larger cohorts of patients with tauopathies. Here we present the design and baseline characteristics of the ongoing phase 2 ARISE study of ABBV-8E12 in PSP patients.
Methods: Male and female patients, at least 40 years of age, are being enrolled at approximately 40 global study sites. Prior to enrollment, patients will have had symptoms for less than 5 years and meet the NINDS-PSP criteria for possible or probable PSP. Patients will be randomized to one of two ABBV-8E12 dose arms or placebo.
Results: The primary efficacy outcome is the change from baseline to week 52 in Progressive Supranuclear Palsy Rating Scale total score. Key secondary endpoints include the Schwab and England Activities of Daily Living Scale, the Unified Parkinson’s Disease Rating Scale Part II, the Clinical Global Impression of Severity and Change, the PSP-Quality of Life subscale scores, and the Visual Analog scale. Table 1 includes baseline characteristics for the first 91 enrolled patients [table1].
Conclusions: The current study is ongoing and designed to evaluate the 52-week safety and efficacy of ABBV-8E12 in PSP patients. In addition to the ongoing phase 2 study in PSP patients, a phase 2 study evaluating ABBV-8E12 in early AD patients is also currently ongoing (NCT02880956).
To cite this abstract in AMA style:
N. Mendonca, R. Bateman, A. Boxer, J. Braunstein, D. Claassen, D. Holtzman, D. Kerwin, B. Rendenbach-Mueller, H. Soares, D. Wang, G. Höglinger. ARISE study: Study Design and Baseline Characteristics for a Phase 2 Trial of the Anti-Tau Antibody ABBV-8E12 in Progressive Supranuclear Palsy [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/arise-study-study-design-and-baseline-characteristics-for-a-phase-2-trial-of-the-anti-tau-antibody-abbv-8e12-in-progressive-supranuclear-palsy/. Accessed May 14, 2025.« Back to 2018 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/arise-study-study-design-and-baseline-characteristics-for-a-phase-2-trial-of-the-anti-tau-antibody-abbv-8e12-in-progressive-supranuclear-palsy/