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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & Exclusion Criteria

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 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.

Exclusion Criteria:

- 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 or hepatic failure or participants with moderate or severe hepatic impairment (Child-Pugh class C) 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.

- Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment (prior to randomization) - Use of other investigational drugs.

- Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant 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 randomization or requirement to receive these vaccinations during study.

- Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05147220
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, Bulgaria, Chile, China, Colombia, Croatia, Denmark, Georgia, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Netherlands, Poland, Saudi Arabia, Slovakia, Spain, Switzerland, Taiwan, United Arab Emirates, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Multiple Sclerosis

Additional Details

The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants. The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS). The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years. A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.

Arms & Interventions

Arms

Experimental: Remibrutinib - Core

Remibrutinib tablet and matching placebo of teriflunomide capsule

Active Comparator: Teriflunomide - Core

Teriflunomide capsule and matching placebo remibrutinib tablet

Experimental: Remibrutinib - Extension

Participants on remibrutinib in Core will continue on remibrutinib tablet

Experimental: Remibrutinib - Extension (on teriflunomide in Core)

Participants on teriflunomide in Core will switch to remibrutinib tablet

Interventions

Drug: - Remibrutinib

tablet taken orally

Drug: - Teriflunomide

capsule taken orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

AZ Integrated Neuro and Spine Integrated MS Center

Phoenix, Arizona, 85037

Site Contact

Brandon Mc Cravey

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