A Phase 3 comparing BTKi to placebo in nrSPMS patients
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with nonrelapsing secondary progressive multiple sclerosis (HERCULES)
IRAS ID
285728
Contact name
Everett Rand Sutherland
Contact email
Sponsor organisation
Genzyme Corporation
Eudract number
2020-000647-30
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1246-7768, WHO; 140884, IND
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
This is a randomized, double-blind,Phase 3 study evaluating the efficacy and safety of SAR442168 (a Bruton's Tyrosine Kinase Inhibitor) compared to placebo in participants with nonrelapsing secondary progressive multiple sclerosis.
SAR442168 penetrates the blood-brain barrier and inhibits Bruton's tyrosine kinase which is present in some cells involved in multiple sclerosis.
This is a double blind study design. Participants will be randomised on a 2:1 ratio to receive the 60mg oral dose of SAR442168 daily or plabebo.
This is an event driven trial, the study will continue until approximately 288 events of 6-month confirmed disability progression have been met.
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.
A pharmaceutical company (Genzyme Corp) is sponsoring the study.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0300
Date of REC Opinion
31 Jul 2020
REC opinion
Further Information Favourable Opinion