ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis

MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS) affecting more than 120,000 people in the UK.and 2.5 million people worldwide. Without disease modifying treatment (DMT),the majority of people with MS (pwMS) will develop significant disability within 10 years of onset, and 50% will require wheelchair assistance within 20 years. convenient, highly effective and CNS penetrant DMT for patients with relapsing multiple sclerosis (pwRMS) administered in short (8-10 days/year over 2 years) treatment courses. It effectively depletes B cells, particularly Memory B cells, a likely key mechanism of disease control in MS. Cladribine is the investigational product in this study as it not currently used to treat patients with an EDSS of 6.5 - 8.5. This is a multi-centre, randomised double-blind placebo-controlled phase IIb to test cladribine tablets (MAVENCLAD®) (3.5mg/kg over 24 months) for safety, efficacy, and cost effectiveness, and to advance mechanistic understanding of its action in people with advanced MS (pwAMS).

NCT Number	NCT04695080
Lead Sponsor	Queen Mary University of London Collaborators: National Institute for Health Research, United Kingdom, Merck Serono Limited, UK, Multiple Sclerosis Society of Great Britain & Northern Ireland, National Multiple Sclerosis Society, Barts & The London NHS Trust
Conditions	Advanced Multiple Sclerosis, Progressive Multiple Sclerosis
Enrollment	204 participants
Start Date	2021-06-25
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-08