This study investigated the safety and tolerability of tolebrutinib in people with different forms of multiple sclerosis (MS)
- Conditions
- Health Condition 1: G35- Multiple sclerosis
- Registration Number
- CTRI/2024/07/071351
- Lead Sponsor
- Sanofi Healthcare India Pvt Limited (SHIPL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
I 01. Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS16004 study or 1 of the 4 Phase 3 pivotal tolebrutinib studies (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
I02: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
I 03. The participant is capable of giving signed informed consent.
E 01. The participant is at risk for or has a persistent chronic, active (including fever =38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator.
E 02. For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection. See the Study Manual for further details.
E 03. Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the long-term safety and tolerability of tolebrutinib in participants with RMS and PMSTimepoint: 60 months
- Secondary Outcome Measures
Name Time Method To assess long-term efficacy of OL tolebrutinib on disability progression, relapse rate (only in participants with RMS), and MRI parameters in participants with RMS and PMSTimepoint: 60 months