SAR442168 compared to placebo in PPMS patients
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)
IRAS ID
285295
Contact name
Owen Pearson
Contact email
Sponsor organisation
Sanofi
Eudract number
2020-000645-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
140884, IND Number; U1111-1238-1318, WHO
Duration of Study in the UK
3 years, 9 months, 27 days
Research summary
Individuals with primary progressive MS (PPMS), need better therapies to reduce the accumulation of disability. The only approved therapy to treat disability progression in PPMS, ocrelizumab, demonstrated modest efficacy and has limited availability in many regions.
SAR442168 penetrates the blood-brain barrier and inhibits Bruton's tyrosine kinase which is present in some cells involved in multiple sclerosis. This mechanism of action may help improve symptoms related to PPMS.
The purpose of this study is to assess the efficacy of SAR442168 compared to placebo measured by 6 month confirmed disability progression assessed via the Expanded Disability Status Scale (EDSS) in participants with PPMS.
This is a double blind, placebo controlled study design. Participants will be randomised on a 2:1 ratio to receive the 60mg oral dose of SAR442168 daily or placebo.
If participants consent, they will attend monthly visits until month 6, and 3 monthly visits from then onwards. Disability assessments, blood and urine samples, physical exam and vital signs will be performed every 3 months. MRI scans will be performed 6 monthly until month 24 and yearly from then onwards.
This study is event driven, and will continue until 290 Confirmed Disease Worsening events, hence a variable study duration between 24 to 48 months. Any participants with a 6 month confirmed disease progression will be eligible for active treatment as a rescue from placebo (SAR442168 or non-study DMT).
The study will include approximately 990 participants, around 45 will be from the UK.
A pharmaceutical company (Genzyme Corp) is sponsoring this study.
This study is planned to take part in 10 NHS centres in the UK.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0207
Date of REC Opinion
16 Oct 2020
REC opinion
Further Information Favourable Opinion