BP43176 - RO7486967 IN PARTICIPANTS WITH PARKINSON’S DISEASE
Research type
Research Study
Full title
A PHASE 1B, ADAPTIVE, MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL DESIGN STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7486967 IN PARTICIPANTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE
IRAS ID
307220
Contact name
Marios Politis
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2021-002345-15
ISRCTN Number
ISRCTN85338453
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND, 156246
Duration of Study in the UK
2 years, 0 months, 8 days
Research summary
Parkinson’s disease (PD) is a chronic disease of the nervous system that gets worse over time. Available treatments cannot stop or slow down the worsening over time.
Some evidence suggests that people with Parkinson’s disease may have more inflammation in the brain. This is thought to be one of the reasons why people get Parkinson's disease and why it worsens over time. A key part of the inflammation in the brain is a protein called NLRP3. RO7486967 (the study drug) blocks NLRP3, which might lower the inflammation in the brain. RO7486967 is an experimental drug, not approved for PD.
The purpose of this study is to investigate what happens to RO7486967 once it is in the body, what RO7486967 does to the body, and to compare the effects (good or bad) of RO7486967 versus placebo on the inflammation in the brain and on Parkinson’s disease symptoms.
Approximately 48 to 72 people (male and post-menopausal female) with Parkinson’s disease aged 50 to 85 years with a diagnosis of early idiopathic PD, who are either treatment-naïve or on stable treatment with levodopa and who fulfil all of the inclusion criteria and none of the exclusion criteria will be able to take part in this study.
The study will take place in the Netherlands, UK and USA. In the UK it is expected that the study will take place in several sites.
This is a phase 1 study, placebo-controlled where the participants will be tested in 2 different groups:
• Group 1 will receive RO7486967, given as two pills in the morning and two pills in the evening every day for about 4 weeks.
• Group 2 will receive placebo, given as two pills in the morning and two pills in the evening every day for about 4 weeks.The study comprises of a Screening Period (up to 60 days), a Treatment period (approximately 28 days from Day 1 to Day 28), and a Follow-up Period (14 days after the last study drug administration).
Eligible participants will be randomised by chance (2:1) to receive RO7486967 or placebo. Treatment duration will be approximately 28 days for all participants. After the last dose of RO7486967 or placebo, all participants will enter a safety follow-up period for 14 days.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0352
Date of REC Opinion
9 Mar 2022
REC opinion
Further Information Favourable Opinion