Clinical Trials Logo

Clinical Trial Summary

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168


Clinical Trial Description

Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months. Participants completing the treatment period will be proposed to enroll in a separate long term safety study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04411641
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 24, 2020
Completion date August 2024

See also
  Status Clinical Trial Phase
Completed NCT04239664 - Acceptance Based Telephone Support When Transitioning to SPMS N/A
Completed NCT02549703 - Mitochondrial Dysfunction and Disease Progression
Terminated NCT01416181 - A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis Phase 3
Withdrawn NCT01181089 - Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS) Phase 1/Phase 2
Active, not recruiting NCT03471338 - Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme N/A
Withdrawn NCT05029609 - Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS Phase 1
Terminated NCT02296346 - Open-Label Study to Evaluate the Efficacy of ECP in Secondary Progressive Multiple Sclerosis N/A
Completed NCT02228213 - Safety and Efficacy Study of MIS416 to Treat Secondary Progressive Multiple Sclerosis Phase 2
Completed NCT00559702 - Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) Phase 1
Terminated NCT03283826 - Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis Phase 1/Phase 2
Completed NCT02253264 - A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients Phase 1
Completed NCT01737372 - A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis N/A
Completed NCT00257855 - A Randomised Controlled Trial of Neuroprotection With Lamotrigine in Secondary Progressive Multiple Sclerosis Phase 2
Recruiting NCT06292923 - A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients Phase 2
Active, not recruiting NCT01228396 - AIMSPRO in the Treatment of Bladder Dysfunction in Secondary Progressive Multiple Sclerosis Phase 2
Completed NCT03896217 - Simvastatin in Secondary Progressive Multiple Sclerosis Phase 2
Completed NCT02495766 - Autologous Mesenchymal Stromal Cells for Multiple Sclerosis Phase 1/Phase 2
Completed NCT00813969 - Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS Phase 1
Completed NCT01077466 - Natalizumab Treatment of Progressive Multiple Sclerosis Phase 2
Terminated NCT00146159 - Study Evaluating Mitoxantrone in Multiple Sclerosis Phase 3