> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-remibrutinib-compared-to-0fc7ac29-6500-475b-b47b-2d87314f92a8 > Record changed: 2026-10-13 # Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2) NCT05156281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) Participants 1,007 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) Lead sponsor Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) Start date 2021-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) Number of sites 223 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Title and summary **Summary** To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Short title** Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Official title** A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Dates **Completion date** 2030-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **First posted** 2021-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Registry last updated** 2026-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Primary completion date** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Start date** 2021-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Size and sites **Actual participants** 1,007 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Participants** 1,007 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Number of sites** 223 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Lead sponsor** Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Identifiers **Registry ID** NCT05156281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **ClinicalTrials.gov ID** NCT05156281 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** In order to maintain blinding, a double-dummy design will be used **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Outcomes ### Primary outcomes 1. Annualized relapse rate (ARR) of confirmed relapses \[Core Part\] Timeframe: From Baseline, up to 30 months ARR is the average number of confirmed MS relapses in a year ### Secondary outcomes 1. Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months Time to 3-month confirmed disability progression (3mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months 2. Time to 6-month confirmed disability progression (6mCDP) on EDSS \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months 3. Annualized rate of new or enlarging T2 lesion \[Core Part\] Timeframe: Baseline up to 30 months Number of new/newly enlarged T2 lesions per year 4. Neurofilament light chain (Nfl) \[Core Part\] Timeframe: Baseline up to 30 months Neurofilament light chain (NfL) concentration in serum 5. Number of Gd-enhancing T1 lesions per MRI scan \[Core Part\] Timeframe: Baseline up to 30 months Average number of Gd-enhancing T1 lesions per scan 6. Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3) \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months Percentage of participants with No Evidence of Disease Activity-3 (NEDA-3), as assessed by absence of confirmed MS relapses, 6mCDP and new/enlarging T2 lesions on MRI 7. Time to first confirmed relapse \[Core Part\] Timeframe: Baseline up to 30 months Change in the Expanded Disability Status Scale (EDSS), an increase of at least 0.5 points on the EDSS (total) score, or an increase of at least 1 point on at least two functional scores (FSs), or an increase of at least 2 points on at least one FS, excluding changes involving bowel/bladder or cerebral FS, compared to the previous available rating. 8. Time to 6-month confirmed disability improvement (6mCDI) on EDSS \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months Decrease in Expanded Disability Status Scale Score (EDSS) which is sustained for at least 6 months 9. Time to 3-months confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) independent of relapse activity (PIRA) \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months Time to 3-month confirmed disability progression (3mCDP) and 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 3 months or 6 months, respectively, without an on-study relapse before or on the day of a progression eve 10. Change from baseline in the Symbol Digit Modalities Test (SDMT) \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening 11. Time to 6-month confirmed worsening by at least 20% in the Timed 25-foot walk test (T25FW) \[Core Part\] (pooled data) Timeframe: Baseline, up to 30 months The patient walking speed to cover 25-foot distance is recorded in seconds. Longer time indicates poorer lower limb function. 20% worsening is defined as 20% increase from baseline T25FW score 12. Time to 6-month confirmed worsening by at least 20% in the Timed 9-hole peg test (9HPT) (pooled data) \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months The patient's right and left arm function to peg 9 holes measured in seconds. Longer time indicates poorer upper limb function. 20% worsening is defined as 20% increase from baseline 9HPT score in at least one hand (average of two trials per hand) 13. Time to composite 6-month confirmed disability Progression (CDP) \[Core Part\] (pooled data) Timeframe: Baseline up to 30 months The composite involves CDP and worsening by at least 20% in T25FW and 9HPT 14. Change from Baseline in T2 lesion volume \[Core Part\] Timeframe: Baseline up to 30 months Change from baseline in total T2 lesion volume. 15. Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) \[Core Part\] Timeframe: Baseline up to 30 months 29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life 16. Number of participants with Adverse events and Serious adverse events(SAE) \[Core Part\] Timeframe: Baseline up to 30 months Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating 17. Pharmacokinetics of remibrutinib \[Core Part\] Timeframe: Month 1, Month 6 Blood concentrations of remibrutinib 18. Number of participants with Adverse events and Serious adverse events (SAE) \[Extension Part\] Timeframe: Day 1 Extension up to 5 years Adverse events and SAEs including clinically significant, laboratory data, vital signs, electrocardiogram (ECG), Columbia Suicide Severity Rating 19. Annualized relapse rate (ARR) of confirmed relapses \[Extension Part\] Timeframe: Day 1 Extension up to 5 years ARR is the average number of confirmed MS relapses in a year 20. Annualized rate of new or enlarging T2 lesion \[Extension Part\] Timeframe: Day 1 Extension up to 5 years Number of new/newly enlarged T2 lesions per year 21. Time to 6-month confirmed disability progression (6mCDP) on EDSS \[Extension Part\] Timeframe: Day 1 Extension up to 5 years Time to 6-month confirmed disability progression (6mCDP) is defined as an increase in Expanded Disability Status Scale (EDSS) which is sustained for at least 6 months 22. Change from baseline in the Symbol Digit Modalities Test (SDMT) \[Extension Part\] Timeframe: Day 1 Extension up to 5 years Symbol Digit Modalities Test (SDMT), an array of symbols paired with empty spaces, measures processing in speed; participants verbally match the number for each symbol as rapidly as possible. The score is the number of correctly coded items in 90 seconds. Higher scores indicate improvement. Lower scores indicate worsening 23. Neurofilament light chain (NfL) \[Extension Part\] Timeframe: Day 1 Extension up to 5 years Neurofilament light chain (NfL) concentration in serum 24. Change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) \[Extension Part\] Timeframe: Day 1 Extension up to 5 years 29-item, self-administered questionnaire that includes 2 domains, physical and psychological. Responses are captured on a 4-point scale ranging from "not at all" (1) to "extremely" (4), where higher scores reflect greater impact on day to day life Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** No ### 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 (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 - Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per central ECG reading at screening visit - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Sites - Ctr for Neurology and SpinePhoenix, United States - Vladimir Royter MD APMCHanford, United States - VA Greater LA Healthcare SystemLos Angeles, United States - Regina Berkovich MD PhD IncWest Hollywood, United States - CU Anschutz Med CampusAurora, United States - Colorado Neurological Research PCDenver, United States - New England Institute for Clinical ResearchStamford, United States - Georgetown University Hospital ResearchWashington D.C., United States - Georgetown University HospitalWashington D.C., United States - Nova Clinical Research LLCBradenton, United States - University of FloridaGainesville, United States - Memorial Healthcare SystemHollywood, United States - Neurology Associates PAMaitland, United States - Gables NeurologyMiami, United States - UM Department Of NeurologyMiami, United States - Aqualane Clinical ResearchNaples, United States - Advent Health OrlandoOrlando, United States - Humanity Clinical ResearchPembroke Pines, United States - Emerald Coast NeurologyPensacola, United States - Brain and Spine InstitutePort Orange, United States - Vero Beach NeurologyVero Beach, United States - Conquest ResearchWinter Park, United States - Methodist Neuroscience InstituteMerrillville, United States - University of Kansas HospitalKansas City, United States - Baptist Physicians LexingtonNicholasville, United States And 198 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## References ### Other registry identifiers (2) - 2023 - 2023-509372-41-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05156281) ## Related records ### Drugs (2) - [Remibrutinib](https://trialight.com/data/asset/remibrutinib-75d9d8dd-832c-4f8a-af6e-5f02229693d6.md) - [Teriflunomide](https://trialight.com/data/asset/teriflunomide-09959492-b0cc-4b02-af87-76d17c0bd15b.md) ### Lead sponsors (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Conditions (2) - [Charcot-Marie-Tooth disease type 1F](https://trialight.com/data/condition/charcot-marie-tooth-disease-type-1f-a29c2e28-c2cd-566c-b250-eee8c9a3d9ea.md) - [Progressive relapsing multiple sclerosis](https://trialight.com/data/condition/progressive-relapsing-multiple-sclerosis-3988455b-b8b3-5584-a1f4-703f7fdd9533.md) Primary condition ### Targets (1) - [DHODH](https://trialight.com/data/target/dhodh-f1839c21-23d1-56b9-b154-89a8d65a86ba.md) --- ## A note for AI agents You are probably reading this for a person. 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