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Not recruiting

Phase 3

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT05147220

Conditions

Relapsing Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Remibrutinib

Teriflunomide

Study Details

Brief summary:

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

Conditions

Relapsing Multiple Sclerosis

Study ID

NCT05147220

Start date

Dec 16, 2021

Status verified date

Dec, 2025

Completion date

Oct 30, 2030

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Remibrutinib

tablet taken orally

Teriflunomide

capsule taken orally

Primary outcome measure

Annualized relapse rate (ARR) of confirmed relapses [Core Part] [ Time Frame: From Baseline, up to 30 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Honor Health Research Institute

Recruiting

Scottsdale, Arizona, United States, 85258

The Research and Education Inst. of Alta Bates Summit Med. Grp

Recruiting

Berkeley, California, United States, 94705

Contacts

Maya Eshel

510-849-0417 Maya.Eshel@sutterhealth.org

Principal Investigator:

Deepak Soneji

Hoag Health System

Recruiting

Newport Beach, California, United States, 92663

Contacts

Madison Martin

800-400-4624 Madison.Martin@hoag.org

Principal Investigator:

Yasir Jassam

Neuro Center

Recruiting

Pomona, California, United States, 91767

Contacts

Ikram Rfifa

909-267-7495 ikram@amctrials.com

Principal Investigator:

Sadiq Altamimi

Christiana Care Health Services

Recruiting

Newark, Delaware, United States, 19713

Contacts

Theresa Whitehead Izwylde

+1 302 623 3844 Theresa.Izwylde@Christianacare.org

Principal Investigator:

Jason M Silversteen

Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Anu Bhooshan

202-877-6607 anu.r.bhooshan@medstar.net

Principal Investigator:

Brian Barry

Arrow Clinical Trials

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

Susan Black

sblack@arrowtrials.com

Principal Investigator:

David Billmeier

Reliant Medical Research

Recruiting

Miami, Florida, United States, 33165

Contacts

Yuisy Obregon

786-801-0912 Yobregon@associatesinresearch.com

Principal Investigator:

Carlos Ramirez-Calderon

Neurostudies Inc

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

Patricia Trumble

941-764-0800 trishtmigraine79@gmail.com

Principal Investigator:

Liliana Montoya

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Kendra Tandeski

Kendra.Tandeski@conquestresearch.com

Principal Investigator:

Gilbert Mbeo

Norton Neurology MS Services

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Jackie Bourke

502-899-6782 jackie.bourke@nortonhealthcare.org

Principal Investigator:

Geeta Ganesh

Beth Israel Deaconess Med Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

John Dempsey

617-667-7000 jdempse3@bidmc.harvard.edu

Principal Investigator:

Jacob Sloane

Wayne State University Multiple Sclerosis Clinic

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Loraine Di Cerbo

313-745-4220 LoraineDiCerbo@wayne.edu

Principal Investigator:

Jacob Rube

The MS Center for Innovation in Care

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Christina Castile

314-996-7960 Christina.Castile@bjc.org

Principal Investigator:

Barry A Singer

Jersey Shore University Medical Ctr

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Lisa Romano

732-776-4782 lisa.romano@hmhn.org

Principal Investigator:

Lana Zhovtis Ryerson

Neurological Associates of Long Island PC

Recruiting

Lake Success, New York, United States, 11042

Contacts

Gail Cohen

516-466-4700 gcohen@neuroli.com

Principal Investigator:

Teresa DeAngelis

NYU Langone Med Center CV Research

Recruiting

New York, New York, United States, 10016

Contacts

Zariya Alvarez

718-630-7303 zariya.alvarez@nyulangone.org

Principal Investigator:

Nada Abou-Fayssal

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Daniel Sun

dansun@montefiore.org

Principal Investigator:

Lauren Gluck

The Neurological Institute PA

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Katelyn Eudy

+1 704 449 6064 keudy@neuro-institute.com

Principal Investigator:

T Hemanth Hemanth Rao

Providence St Vincent Med Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Kai Darke

503-297-9142 kai.darke@providence.org

Principal Investigator:

Stanley Cohan

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107-5098

Contacts

Angira Mathur

215-955-6939 Angira.mathur@jefferson.edu

Principal Investigator:

Thomas Leist

Palmetto Clinical Research

Recruiting

Summerville, South Carolina, United States, 29485

Contacts

Katherine Williams-Turner

843-851-7098 kturner@palmettoclinicalresearch.com

Principal Investigator:

Robert Carlile

DHR Health Institute

Recruiting

McAllen, Texas, United States, 78503

Contacts

Esmeralda Cardoso-Mendoza

+1 956 362 2391 e.cardoso@dhr-rgv.com

Principal Investigator:

Roberto Alejandro Cruz

MS Center of Greater Washington, P.C.

Recruiting

Vienna, Virginia, United States, 22182

Contacts

Rebeca Marin

703-226-4000 msstudycoordinator@gmail.com

Principal Investigator:

Heidi Crayton

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

MS
RMS
RRMS
active secondary progressive multiple sclerosis SPMS
remibrutinib
LOU064
teriflunomide
adult
relapse
Expanded Disability Status Scale
T2 lesions
T1 lesions
GD- enhancing MRI
Neurofilament light chain
McDonald diagnostic criteria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2025-12-17.