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
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
This is a Phase 3 extension, global, multicenter 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 LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).
SUBSTUDY: ToleDYNAMIC substudy
Participants with relapsing MS from the Phase 2b LTS16004 parent study will continue open-label (OL) tolebrutinib.
All participants from the Phase 3 parent studies (EFC16033, EFC16034, EFC16645, and EFC16035) will learn which treatment they received in the parent study:
The treatment duration per participant will be approximately 4 years of OL tolebrutinib.
Inclusion Criteria:
- Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
OR
- The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.
ToleDYNAMIC Substudy: Inclusion criteria are those of the main study
Exclusion Criteria:
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
ToleDYNAMIC Substudy: Exclusion criteria are those of the main study
Birmingham, Alabama 35233, United States
Los Alamitos, California 90720, United States
San Diego, California 92037-0943, United States
Washington D.C., District of Columbia 20007, United States
Kansas City, Kansas 66160-7321, United States
Farmington Hills, Michigan 48334, United States
Owosso, Michigan 48867, United States
Patchogue, New York 11772, United States
Stony Brook, New York 11794, United States
Winston-Salem, North Carolina 27157, United States
Centerville, Ohio 45459, United States
Cleveland, Ohio 44195, United States
Columbus, Ohio 43221, United States
Burlington, Vermont 05405, United States
CABA, Buenos Aires C1012AAR, Argentina
CABA, Buenos Aires C1023AAB, Argentina
CABA, Buenos Aires F.D. C1021, Argentina
CABA, Buenos Aires F.D. C1424, Argentina
CABA, Buenos Aires F.D. C1425 BKU, Argentina
Ostrava - Poruba, 70852, Czechia
Praha 5 - Motol, 15000, Czechia
Sagamihara-shi, Kanagawa 252-0392, Japan
Moriguchi-shi, Osaka 570-8507, Japan
Kawagoe-shi, Saitama 350-8550, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Veracruz. Mexico City, Veracruz 91900, Mexico
Glogow Mlp., Podkarpackie Voivodeship 36-060, Poland
Lleida / Lleida, Lleida [Lérida] 25198, Spain
Madrid / Madrid, Madrid, Comunidad de 28007, Spain