Phase
Condition
Sarcopenia
Neuropathy
Polymyositis (Inflammatory Muscle Disease)
Treatment
Tolebrutininb
Placebo
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
- History of abnormal neuromuscular transmission demonstrated by single-fiberelectromyography or repetitive nerve stimulation.
- History of positive edrophonium chloride test.
- 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
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.
Study Design
Study Description
Connect with a study center
Investigational Site Number :1240004
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Investigational Site Number :1240003
London, Ontario N6A 5A5
CanadaSite Not Available
Investigational Site Number :1560003
Chengdu, 610041
ChinaSite Not Available
Investigational Site Number :1560001
Shanghai, 200040
ChinaSite Not Available
Investigational Site Number :1560002
Wuhan, 430030
ChinaSite Not Available
Investigational Site Number :3480002
Pécs, 7623
HungarySite Not Available
Investigational Site Number :3480001
Szeged, 6725
HungarySite Not Available
Investigational Site Number :3800002
Milano, Lombardia 20133
ItalySite Not Available
Investigational Site Number :3800001
Milano, 20132
ItalySite Not Available
Investigational Site Number :3800004
Napoli, 80131
ItalySite Not Available
Investigational Site Number :3800003
Roma, 00168
ItalySite Not Available
Investigational Site Number :3920002
Sagamihara-shi, Kanagawa 252-0392
JapanSite Not Available
Investigational Site Number :6160001
Zabrze, 41-800
PolandSite Not Available
Investigational Site Number :7240001
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Investigational Site Number :7240003
Hospitalet de Llobregat, Catalunya [Cataluña] 08907
SpainSite Not Available
Investigational Site Number :7240005
Madrid, Madrid, Comunidad De 28046
SpainSite Not Available
Investigational Site Number :7240006
Donostia, Pais Vasco 20014
SpainSite Not Available
Investigational Site Number :8260002
Exeter, Devon EX2 5DW
United KingdomSite Not Available
Investigational Site Number :8260001
Liverpool, L9 7LJ
United KingdomSite Not Available
Georgetown University-Site Number:8400008
Washington, District of Columbia 20007
United StatesSite Not Available
SFM Clinical Research, LLC-Site Number:8400006
Boca Raton, Florida 33487
United StatesSite Not Available
University of South Florida Health- Morsani Center for Advanced Healthcare-Site Number:8400001
Tampa, Florida 33612-6601
United StatesSite Not Available
Harvard Medical School - Brigham and Women's Hospital-Site Number:8400004
Boston, Massachusetts 02115
United StatesSite Not Available
Neurology Center of San Antonio, PA-Site Number:8400009
San Antonio, Texas 00000
United StatesSite Not Available
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