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

NCT05147220

Run by

Novartis Pharmaceuticals

People needed

1000

Starts

2021-12-16

Expected to finish

2030-10-30

Last updated by the study team

2026-05-29

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

• Novartis Investigative Site — Beijing, China
• AZ Integrated Neuro and Spine — Phoenix, Arizona, United States
• Center for Neurosciences — Tucson, Arizona, United States
• The Belinga Clinic — Fort Smith, Arkansas, United States
• The Research and Education Inst of Alta Bates Summit Med Grp — Berkeley, California, United States
• The Neuron Clinic — Chula Vista, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Hoag Health System — Newport Beach, California, United States
• SC3 Research Pasadena — Pasadena, California, United States
• Neuro Center — Pomona, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Neurology of Central FL Res Ctr — Altamonte Springs, Florida, United States
• Arrow Clinical Trials — Daytona Beach, Florida, United States
• Homestead Assoc In Research Inc — Homestead, Florida, United States
• Reliant Medical Research — Miami, Florida, United States
• Neurological Services of Orlando PA — Orlando, Florida, United States
• Orlando Health Clinical Trials — Orlando, Florida, United States
• Comprehensive Neurology Clinic — Orlando, Florida, United States
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Neurostudies Inc — Port Charlotte, Florida, United States
• Accel Research Sites St Pete-Largo — Seminole, Florida, United States
• University Of South Florida — Tampa, Florida, United States
• Novartis Investigative Site — Beijing, China

Full record on ClinicalTrials.gov

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