Objective: To describe baseline characteristics of the participants with progressive supranuclear palsy (PSP) enrolled in the ongoing PASSPORT (NCT03068468) phase 2 study.

Background: PSP is a rare, rapidly progressing, neurodegenerative 4-repeat tauopathy. Currently, no medications are approved for treatment of PSP. BIIB092 is a humanized IgG4P monoclonal antibody directed against N-terminal tau fragments found extracellularly (eTau) in the interstitial and cerebrospinal fluid and hypothesized to spread tau pathology between neurons. BIIB092 has been shown to suppress eTau in cerebrospinal fluid of participants with PSP.[1]

Methods: PASSPORT is a randomized, double-blind, placebo-controlled, parallel group study. Participants aged 41–86 years diagnosed with possible or probable PSP (MDS criteria [2]) are randomized to 52 weeks of treatment with BIIB092 or placebo administered intravenously every 4 weeks. Planned recruitment is 396. The primary efficacy endpoint is the change from baseline to Week 52 in BIIB092- vs. placebo-treated participants on the PSP Rating Scale (PSPRS) score. Change from baseline to Week 52 will also be evaluated on the Clinical Global Impression of Severity scale (CGI-S), Movement Disorder Society – modified-Unified Parkinson’s Disease Rating Scale Part II score (MDS-UPDRS Part II), PSP Quality of Life scale (PSP-QoL), and Repeatable Battery for the Assessment of Neuropsychological Disease Severity scale (RBANS).

Results: PASSPORT began enrolling in April 2017 and is ongoing; select baseline characteristics (age, sex, race, ethnicity, height, weight, body mass index, symptom duration) of the initial enrollees will be presented. In addition, select baseline disease characteristics (PSPRS, MDS-UPDRS Part II, CGI-S, RBANS, PSP-QoL) will be presented.

Conclusions: Baseline characteristics of enrolled PASSPORT participants will be described to provide contemporaneous information on recruitment into PSP clinical trials.

References: 1. Qureshi I, Grundman M, Tirucherai GS, et al. Multiple ascending dose study of the tau-directed monoclonal antibody BIIB092 in patients with progressive supranuclear palsy. Poster presented at 10th Clinical Trials on Alzheimer’s Disease (CTAD). November 1–4,2017. Poster LBP32. 2. Höglinger GU, Respondek G, Stamelou M, et al, for the Movement Disorder Society-endorsed PSP Study Group. Clinical Diagnosis of Progressive Supranuclear Palsy – The Movement Disorder Society Criteria. Movement Disorders, 2017;32(6):853-864.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/passport-an-ongoing-phase-2-study-in-patients-with-psp-baseline-characteristics/