Stopped: For strategic reasons the Tolebrutinib MG study has been terminated
This was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tolebrutinib compared with placebo in adult participants aged 18 to 85 years old with moderate-to-severe generalized myasthenia gravis (gMG), who received Standard of Care (SoC). The double-blind (DB) treatment period of 26 weeks comprised of 7 site visits followed by a 2-year open label extension (OLE) period with quarterly visits. The efficacy of tolebrutinib versus placebo during the DB period was assessed by clinical evaluations, including scales based on physician examination or direct participant feedback i.e., patient reported outcomes (PROs). These evaluations continued during the OLE to measure long term efficacy and safety.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DB Period: Change From Baseline in Myasthenia Gravis-activities of Daily Living (MG-ADL) Total Score at Week 26
Timeframe: Baseline (Day 1), Week 26
OLE Period: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events Leading to Permanent Study Intervention Discontinuation and Adverse Events of Special Interests (AESIs)
Timeframe: From Week 27 up to an additional 35 weeks in the OLE period until the study termination (i.e., up to Week 61)
OLE Period: Number of Participants With Hematological Abnormalities
Timeframe: From Week 27 up to an additional 35 weeks in the OLE period until the study termination (i.e., up to Week 61)
OLE Period: Number of Participants With Clinical Chemistry Parameter Abnormalities
Timeframe: From Week 27 up to an additional 35 weeks in the OLE period until the study termination (i.e., up to Week 61)
OLE Period: Number of Participants With Electrocardiogram (ECG) Abnormalities
Timeframe: From Week 27 up to an additional 35 weeks in the OLE period until the study termination (i.e., up to Week 61)
OLE Period: Number of Participants With Vital Signs Abnormalities
Timeframe: From Week 27 up to an additional 35 weeks in the OLE period until the study termination (i.e., up to Week 61)