SAR442168 compared to teriflunomide in RMS patients
Research type
Research Study
Full title
A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis (GEMINI 2)
IRAS ID
285292
Contact name
Charlotte Van Zyl
Contact email
Sponsor organisation
Sanofi
Eudract number
2020-000644-55
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
140884, IND Number; U1111-1238-1418, WHO universal trial number
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
There is a need for more efficacious treatments for patients with relapsing multiple sclerosis (RMS), especially those that target disease mechanisms in the central nervous system.
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 RMS.
The purpose of this study is to assess the efficacy of SAR442168 compared to daily teriflunomide measured by annualised adjudicated relapse rate in participants with RMS.
This is a double blind, double-dummy study design. Participants will be randomised on a 1:1 ratio to receive the 60mg oral dose of SAR442168 daily and a placebo to match the teriflunomide tablet, or 14 mg oral teriflunomide as well as a placebo to match the SAR442168 tablet daily.
Teriflunomide is marketed by Sanofi for the treatment of RMS and is approved for use on the NHS.
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 169 Confirmed Disease Worsening events, hence a variable study duration between 18 to 36 months.
The study will include approximately 900 participants, around 25 will be from the UK.
Participants can continue to take the study medication until the end of the study unless the participant is no longer deriving a benefit, they have unacceptable side effects, or they or their doctor decide not to continue treatment.
A pharmaceutical company (Genzyme Corp) is sponsoring this study.
This study is planned to take part in 5 NHS centres in the UK.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0165
Date of REC Opinion
28 Jul 2020
REC opinion
Further Information Favourable Opinion