251PP301 Phase IIb Efficacy and Safety Progressive Supranuclear Palsy

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants with Progressive Supranuclear Palsy

• IRAS ID

  225746

• Contact name

  Huw Morris

• Contact email

  h.morris@ucl.ac.uk

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2016-002554-21

• Duration of Study in the UK

  2 years, 11 months, 30 days

• Research summary

  This is a phase IIb study for patients with Progressive Supranuclear Palsy (PSP). BMS-986168 is an investigational drug being developed for the treatment of PSP. The purpose of this study is to evaluate the effects of the investigational drug BMS-986168 compared to placebo. The study is randomised (patients will be assigned one of two treatment groups), multicentre and double blind (neither the patient nor the study doctor will know the assigned treatment arm).

  The study is split into three sections, screening – to check for eligibility, treatment and follow up. If a patient is deemed eligible according to the screening criteria they will be randomised to receive either BMS-986168 or placebo. During the treatment phase, patients will be expected to attend clinic every four weeks for the first 52 weeks. After successful completion of the first portion of the study, patients may choose to take part in the open label portion of the study. At this point, all patients will receive BMS-986168. The duration of the open label portion of the study will vary. Patients could continue to receive treatment for at least two years or longer depending on local commercial availability of BMS-986168 or the study closure by the sponsor, whichever comes first.

  The study will take place at 6 NHS hospital sites in the UK and 15 patients are expected to be recruited. A total of 396 patients will take part worldwide.

  Tests undertaken will include but are not limited to; physical exam, vital signs, height, weight, pregnancy test, MRI, electrocardiogram, blood tests, questionnaires.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/0736

• Date of REC Opinion

  19 May 2017

• REC opinion

  Favourable Opinion