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228PD201 Phase 2a study testing BIIB054 for Parkinson’s Disease

  • Research type

    Research Study

  • Full title

    A Multicenter, Randomized, Double-Blind, Placebo-Controlled\nStudy, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety,\nPharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease

  • IRAS ID

    238640

  • Contact name

    Thomas Foltynie

  • Contact email

    t.foltynie@ucl.ac.uk

  • Sponsor organisation

    Biogen Idec Research Limited

  • Eudract number

    2016-004610-95

  • Clinicaltrials.gov Identifier

    NCT03318523

  • Duration of Study in the UK

    4 years, 7 months, 21 days

  • Research summary

    Biogen is developing BIIB054 for the treatment of Parkinson’s Disease. BIIB054 targets aggregated forms of alpha-synuclein (α-syn), the primary structural component of the Lewy bodies (LBs) and Lewy neuritis (LNs) which are the pathological hallmarks of Parkinson’s Disease. The distribution, density, and associated severity of LBs is associated with the severity of the clinical disease. Early stage Parkinson’s Disease patients will be selected for this study as BIIBO54 may be more effective in modifying the course of the disease when less neuronal damage is evident and the spread of disease pathology is more limited\n\nThis is a Phase 2a, randomised, double-blind, parallel-group, placebo-controlled study (Year 1) with an active-treatment dose-blinded period (Year 2) that will examine the safety, Pharmacokinetics (the study of the bodily absorption, distribution, metabolism, and excretion of BIIB054)and Pharmacodynamics (the study of the biochemical and physiologic effect of BIIB054), administered every 4 weeks via intravenous (IV) infusion to adults with Parkinson’s Disease. The primary objective of the study is to evaluate the dose-related safety of BIIB054. Approximately 311 participants will be enrolled at about 85 sites globally.

  • REC name

    South West - Central Bristol Research Ethics Committee

  • REC reference

    18/SW/0023

  • Date of REC Opinion

    4 Apr 2018

  • REC opinion

    Further Information Favourable Opinion