An extension study of UCB0599 in participants with PD

• Research type

  Research Study

• Full title

  A DOSE-BLINDED EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY, SAFETY, AND TOLERABILITY OF UCB0599 IN STUDY PARTICIPANTS WITH PARKINSON’S DISEASE

• IRAS ID

  1007383

• Contact name

  Adi Moloudi

• Contact email

  zahraAdi.Moloudi@ucb.com

• Sponsor organisation

  UCB Biopharma SRL

• Eudract number

  2022-500424-30

• Clinicaltrials.gov Identifier

  NCT05543252

• Research summary

  Parkinson’s disease (PD) is the second most common neurodegenerative disease. It is estimated that 10 million people are living with PD worldwide.
  PD is a type of nervous system disorder that affects movement and becomes worse over time. In the brains of people with PD:
  ● Cells that make a chemical messenger, dopamine, stop working and eventually die (neurodegeneration). Decrease in dopamine causes movement issues.
  ● There is buildup of a protein called alpha-synuclein (ASYN). Researchers think that stopping this buildup of abnormal ASYN could help delay neurodegeneration/movement issues. The study drug, UCB0599, is designed to stop this buildup.

  In an ongoing study (orchestra PD0053), UCB0599 is being tested to see how safe it is and if it works better than placebo.
  In this study (orchestra XT PD0055), researchers want to learn if UCB0599 is safe and if it works for a longer period of time in the same participants.

  PD0055 will include up to 450 participants that completed treatment in PD0053. Participants will receive treatment based on what they received in PD0053, of UCB0599 for the following 18 months (no placebo in PD0055).
  After Month 18, participants will change their dose of UCB0599 to the dose the researchers decide is best based on the results so far. UCB0599 will be received for 30 months or longer. Participants can receive symptomatic treatments.

  Participants will visit the study site 10 times. One of these will coincide with a PD0053 visit. Another one of these will happen over the phone. At some visits, the following tests or procedures will happen:
  ● weight/vital signs checked
  ● physical and neurological evaluations
  ● blood/urine samples collected
  ● heart health checked (ECG)
  ● DaT-SPECT scans
  ● medications and doses discussion
  ● PD symptoms checked (questionnaires)
  ● cerebrospinal fluid collection (optional)

• REC name

  North East - York Research Ethics Committee

• REC reference

  23/NE/0094

• Date of REC Opinion

  27 Sep 2023

• REC opinion

  Further Information Favourable Opinion