Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Inclusion Criteria:

• 18 to 55 years of age

• Diagnosis of RMS according to the 2017 McDonald diagnostic criteria

• At least: 1 documented relapse within the previous year. OR 2 documented relapseswithin the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12months.

• EDSS score of 0 to 5.5 (inclusive)

• Neurologically stable within 1 month

Exclusion Criteria:

• Diagnosis of primary progressive multiple sclerosis (PPMS)

• Disease duration of more than 10 years in participants with EDSS score of 2 or lessat screening

• History of clinically significant CNS disease other than MS

• Ongoing substance abuse (drug or alcohol)

• History of malignancy of any organ system (other than complete resection oflocalized basal cell carcinoma of the skin or in situ cervical cancer),

• Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML

• suicidal ideation or behavior

• Evidence of clinically significant cardiovascular, neurological, psychiatric,pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders orgastrointestinal disease that can interfere with interpretation of the study resultsor protocol adherence

• Participants who have had a splenectomy

• Active clinically significant systemic bacterial, viral, parasitic or fungalinfections

• Positive results for syphilis or tuberculosis testing

• Uncontrolled disease states, such as asthma, or inflammatory bowel disease, whereflares are commonly treated with oral or parenteral corticosteroids

• Active, chronic disease of the immune system (including stable disease treated withimmune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoidarthritis, systemic lupus erythematosus, etc.) with the exception of well-controlleddiabetes or thyroid disorder.

• Participants with a known immunodeficiency syndrome (AIDS, hereditary immunedeficiency, drug induced immune deficiency), or tested positive for HIV antibody

• History or current treatment for hepatic disease including but not limited to acuteor chronic hepatitis, cirrhosis (including all Child-Pugh classes) or hepaticfailure or any chronic liver or biliary disease.

• History of severe renal disease or creatinine level

• Participants at risk of developing or having reactivation of hepatitis

• Hematology parameters at screening:

• Hemoglobin: < 10 g/dl (<100g/L)

• Platelets: < 100000/mm3 (<100 x 109/L)

• Absolute lymphocyte count < 800/mm3 (<0.8 x 109/L)

• White blood cells: <3 000/mm3 (<3.0 x 109/L)

• Neutrophils: < 1 500/mm3 (<1.5 x 109/L)

• B-cell count < 50% lower limit of normal (LLN) or total IgG & total IgM < LLN (only required for participants who had a history of receiving B-celltherapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)

• History or current diagnosis of significant ECG abnormalities

• Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per centralECG reading at screening visit

• Use of other investigational drugs

• Requirement for anticoagulant medication or use of dual anti-platelet therapySignificant bleeding risk or coagulation disorders,

• History of gastrointestinal bleeding

• Major surgery within 8 weeks prior to screening

• History of hypersensitivity to any of the study drugs or excipients

• Pregnant or nursing (lactating) female participants, prior to randomization

• Women of childbearing potential not using highly effective contraception

• Sexually active males not agreeing to use condom

• Have received any live or live-attenuated vaccines within 6 weeks of randomizationor requirement to receive these vaccinations during study

• Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers withintwo weeks prior to randomization

Inclusion to Extension part:

• Participants who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP)

Other inclusion and exclusion criteria may apply