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 of signingthe 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 myasthenia gravisfoundation of America (MGFA) Clinical Classification Class II, III, or IV, and likelynot in need of a respirator for the duration of the study, as judged by theInvestigator.
• 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 prior diagnosissupported 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 daily livingscale at screening and Day 1 with greater than half of the score attributed tonon-ocular items.

Exclusion Criteria:

• MGFA Class I (ocular MG) or Class V.
• Participants had undergone thymectomy within 6 months of screening or having a plannedthymectomy 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 4 weeksof the Screening Visit (>=38 degree Celsius; however, if due to brief and mild ear,nose, throat viral infection participant might be included based on the Investigator'sjudgment); A history of infection with human immunodeficiency virus (HIV); A historyof T-lymphocyte or T-lymphocyte-receptor vaccination, transplantation (including solidorgan, 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 squamous orbasal cell carcinoma of the skin and malignant thymoma that had been resected or wereconsidered as cured by any treatment with no evidence of metastatic disease for >=3years) 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 aparticipant's potential participation in a clinical trial.