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

Running, not enrolling · Phase 3

Conditions studied: Relapsing Multiple Sclerosis

In brief

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

Key facts

Study ID

NCT05156281

Run by

Novartis Pharmaceuticals

People needed

1007

Starts

2021-12-13

Expected to finish

2030-10-30

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.
• EDSS score of 0 to 5.5 (inclusive)
• Neurologically stable within 1 month

You may not qualify if…

• Diagnosis of primary progressive multiple sclerosis (PPMS)
• Disease duration of more than 10 years in participants with EDSS score of 2 or less at 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 of localized 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 or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
• Participants who have had a splenectomy
• Active clinically significant systemic bacterial, viral, parasitic or fungal infections
• Positive results for syphilis or tuberculosis testing
• Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
• Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
• Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
• History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis (including all Child-Pugh classes) or hepatic failure 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-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
• History or current diagnosis of significant ECG abnormalities

Where it is running

• Ctr for Neurology and Spine — Phoenix, Arizona, United States
• Vladimir Royter MD APMC — Hanford, California, United States
• VA Greater LA Healthcare System — Los Angeles, California, United States
• Regina Berkovich MD PhD Inc — West Hollywood, California, United States
• CU Anschutz Med Campus — Aurora, Colorado, United States
• Colorado Neurological Research PC — Denver, Colorado, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• Georgetown University Hospital Research — Washington D.C., District of Columbia, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Nova Clinical Research LLC — Bradenton, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Neurology Associates PA — Maitland, Florida, United States
• Gables Neurology — Miami, Florida, United States
• UM Department Of Neurology — Miami, Florida, United States
• Aqualane Clinical Research — Naples, Florida, United States
• Advent Health Orlando — Orlando, Florida, United States
• Humanity Clinical Research — Pembroke Pines, Florida, United States
• Emerald Coast Neurology — Pensacola, Florida, United States
• Brain and Spine Institute — Port Orange, Florida, United States
• Vero Beach Neurology — Vero Beach, Florida, United States
• Conquest Research — Winter Park, Florida, United States
• Methodist Neuroscience Institute — Merrillville, Indiana, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Novartis Investigative Site — Essen, Germany

Full record on ClinicalTrials.gov

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