LIGHTHOUSE

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122/DNL151 in Participants with Parkinson’s Disease and Pathogenic LRRK2 Variants

• IRAS ID

  1006106

• Contact name

  Matthew Stagray

• Contact email

  clinicaltrials@biogen.com

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2022-000747-77

• Clinicaltrials.gov Identifier

  NCT05352919

• Research summary

  The purpose of this study is to see whether the study drug (BIIB122) works in people with early-stage Parkinson’s Disease (PD), how safe it is in terms of side effects, and how the body handles taking it (tolerability). Approx. 400 participants will participate and will be aged 30-80 and have been diagnosed with PD in the past 5 years.
  Participants will be assigned randomly to 1 of 2 groups to receive:
  • 225 mg of study drug or
  • placebo.
  Placebo looks like the study drug but contains no active medication. It’s used to help determine if results are due to the study drug or something else. Neither participants nor the study doctor will know if they receive study drug or placebo. Participants have a 50% of receiving the study drug.

  Estimated duration for each participant is a minimum of approx. 103 weeks and a maximum of 187 weeks in total. Participants will need to attend up to 23 visits.
  The study will have 3 periods:
  • Screening period (up to 6 weeks)
  • Treatment period (up to 180 weeks)
  • Follow-up period (2 weeks after last dose)

  The study has 2 optional sub-studies (add-on to main study, designed to address a research question not part of main study). There are also 2 other optional research components.
  • Imaging sub-study: will look at how the brain reacts to the study drug by collecting brain images using magnetic resonance imaging (MRI) & positron emission tomography (PET) scans.
  • Biofluid sub-study: will look at biomarkers relevant to PD and in reaction to the study drug by taking additional cerebrospinal fluid (CSF) and blood samples.
  • Pharmacogenetics research: will look at DNA to learn how differences in people’s genes affect the diseases they get and how they respond to drugs. These tests will use residual blood from samples given as part of the main study.
  • Future research: will look at samples (blood, CSF, urine), and/or brain images for future research.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  22/SC/0352

• Date of REC Opinion

  7 Nov 2022

• REC opinion

  Further Information Favourable Opinion