An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis. (LTS17043)

Research summary

This is a Phase 3 extension, global, multicenter, OL study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS16004 study or 1 of the 4 Phase 3 tolebrutinib pivotal studies (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]). The LTS17043 study includes participants with RMS, PPMS, or NRSPMS who have completed the Phase 2b LTS16004 study or 1 of the 4 Phase 3 pivotal tolebrutinib studies (EFC16033, EFC16034, EFC16645, and EFC16035) on IMP, opt to enroll in the LTS17043 study, and provide informed consent.

Principal Investigator

Dr Ruth Fernandes Geraldes

Contact us

Email: ana.cavey@ouh.nhs.uk

IRAS number

1008539