Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis

Inclusion Criteria:

• Participants were 18 years of age to 85 years of age inclusive, at the time ofsigning the informed consent.

• Participants with a diagnosis of gMG at screening with generalized muscle weaknessmeeting the clinical criteria for diagnosis of MG, as defined by the myastheniagravis foundation of America (MGFA) Clinical Classification Class II, III, or IV,and likely not in need of a respirator for the duration of the study, as judged bythe Investigator.

• Positive serologic testing for anti-acetylcholine receptor (anti-AChR) oranti-muscle-specific kinase (anti-MuSK) autoantibody at screening OR

• Seronegative for both anti-AChR and anti-MuSK autoantibodies and with priordiagnosis supported by greater than or equal to (>=) 1 of the following 3 tests:

1. History of abnormal neuromuscular transmission demonstrated by single-fiberelectromyography or repetitive nerve stimulation.

2. History of positive edrophonium chloride test.

3. Participant had demonstrated improvement in gMG signs on oralacetylcholinesterase inhibitors as assessed by the treating physician.

• The participant had a total score >=6 on myasthenia gravis-activities of dailyliving scale at screening and Day 1 with greater than half of the score attributedto non-ocular items.

Exclusion Criteria:

• MGFA Class I (ocular MG) or Class V.

• Participants had undergone thymectomy within 6 months of screening or having aplanned thymectomy during the trial period.

• The participant had a history of infection or might be at risk for infection: Ahistory of active or latent tuberculosis (TB); Participants at risk of developing orhaving reactivation of hepatitis; Persistent chronic or active recurring infectionrequired treatment with antibiotics, antivirals, or antifungals; Fever within 4weeks of the Screening Visit (>=38 degree Celsius; however, if due to brief and mildear, nose, throat viral infection participant might be included based on theInvestigator's judgment); A history of infection with human immunodeficiency virus (HIV); A history of T-lymphocyte or T-lymphocyte-receptor vaccination,transplantation (including solid organ, stem cell, and bone marrow transplantation)and/or antirejection therapy.

• Any malignancy within the past 5 years prior Screening Visit (except for effectivelytreated carcinoma in situ of the cervix, adequately treated non-metastatic squamousor basal cell carcinoma of the skin and malignant thymoma that had been resected orwere considered as cured by any treatment with no evidence of metastatic disease for >=3 years) will be exclusionary.

• Conditions that might predispose the participant to excessive bleeding.

• Clinically significant laboratory abnormalities (including evidence of liver injury)or electrocardiogram abnormalities at Screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.