Clinical Trials Logo
  1. Home
  2. Relapsing Multiple Sclerosis
  3. NCT04410978

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1) — GEMINI 1  

Relapsing Multiple Sclerosis Clinical Trial

Official title:
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis

Clinical Trial Summary

Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites 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 18 to 36 months. Participants completing the study will be offered to participate in a long term safety study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04410978
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 30, 2020
Completion date August 15, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04121065 - Role of ADA SNPs in Subjects With Relapsing Multiple Sclerosis (RMS)
Active, not recruiting NCT03996291 - Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis Phase 2
Recruiting NCT04510220 - 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis Phase 3
Terminated NCT02241785 - Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies Phase 4
Completed NCT02792218 - Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis Phase 3
Completed NCT01412333 - A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis Phase 3
Completed NCT03257358 - A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod Phase 4
Completed NCT01628393 - Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients Phase 2/Phase 3
Completed NCT04626921 - A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis Phase 2/Phase 3
Withdrawn NCT02234869 - Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy Phase 4
Withdrawn NCT05077956 - Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis
Active, not recruiting NCT04486716 - A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis Phase 3
Recruiting NCT04121403 - Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) Phase 3
Recruiting NCT05809986 - Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Terminated NCT00988052 - A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course Phase 3
Active, not recruiting NCT05232825 - A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis Phase 3
Terminated NCT01047319 - A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis Phase 3
Completed NCT04847596 - A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Completed NCT01127750 - Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients Phase 3
Completed NCT01006941 - Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study Phase 2