A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis

Prior treatment

• History of suicidal behavior within 6 months prior to Screening
• Patients on anticoagulation, or antiplatelet therapy
• Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days
• Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
• History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.

Other illness

• Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.
• History or current diagnosis of other neurological disorders that may mimic MS
• Active, clinically significant viral, bacterial, or fungal infection
• History of any other significant active medical condition
• Any prior history of malignancy

Lab values

• Clinically significant laboratory abnormalities at Screening.

Other

• The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria
• History or current diagnosis of progressive multifocal leukoencephalopathy

• 18 to 60 years of age, inclusive, at the time of signing the informed consent.
• Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria
• Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013
• Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).
• Absence of clinical relapses for at least 24 months.