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

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

ClinicalTrials.gov Identifier: NCT05156281

Novartis Reference Number: CLOU064C12302

Last Update: Nov 17, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Relapsing Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Dec 13, 2021
Completion date 
Nov 23, 2029
Gender 
All
Age(s)
18 Years - 55 Years (Adult)

Interventions

Drug
Remibrutinib
tablet taken orally
Drug
Teriflunomide
capsule taken orally

Eligibility 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 strong CYP3A4 inducers within two weeks prior to randomization

Inclusion to Extension part:

• patient 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 Locations

United States
Novartis Investigative Site
Recruiting
Hanford, 93230
California
United States
Novartis Investigative Site
Recruiting
Bradenton, 34209
Florida
United States
Novartis Investigative Site
Recruiting
Maitland, 32751
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Recruiting
Pembroke Pines, 33024
Florida
United States
Novartis Investigative Site
Recruiting
Pensacola, 32514
Florida
United States
Novartis Investigative Site
Recruiting
Port Orange, 32127
Florida
United States
Novartis Investigative Site
Recruiting
Vero Beach, 32960
Florida
United States
Novartis Investigative Site
Recruiting
Suwanee, 30024
Georgia
United States
Novartis Investigative Site
Recruiting
Merrillville, 46410
Indiana
United States
Novartis Investigative Site
Recruiting
New Orleans, 70121
Louisiana
United States
Novartis Investigative Site
Recruiting
Columbus, 43235
Ohio
United States
Novartis Investigative Site
Recruiting
Dayton, 45408
Ohio
United States
Novartis Investigative Site
Recruiting
Greer, 29650
South Carolina
United States
Novartis Investigative Site
Recruiting
El Paso, 79935
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77094
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78229
Texas
United States
Novartis Investigative Site
Recruiting
Seattle, 98133
Washington
United States
Novartis Investigative Site
Recruiting
Crab Orchard, 25827
West Virginia
United States
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1012AAR
-
Argentina
Brazil
Novartis Investigative Site
Recruiting
Curitiba, 81210-310
PR
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90110-000
RS
Brazil
Bulgaria
Novartis Investigative Site
Recruiting
Plovdiv, 4002
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1407
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1413
-
Bulgaria
Canada
Novartis Investigative Site
Recruiting
Greenfield Park, J4V 2J2
Quebec
Canada
Novartis Investigative Site
Recruiting
Levis, G6W 0M5
Quebec
Canada
China
Novartis Investigative Site
Recruiting
Fuzhou, 350025
Fujian
China
Novartis Investigative Site
Recruiting
Shanghai, 200040
-
China
Croatia
Novartis Investigative Site
Recruiting
Vukovar, 32000
-
Croatia
Novartis Investigative Site
Recruiting
Zagreb, 10000
-
Croatia
France
Novartis Investigative Site
Recruiting
Nantes, 44093
Cedex 1
France
Novartis Investigative Site
Recruiting
CAEN Cedex, 14033
-
France
Novartis Investigative Site
Recruiting
Grenoble, 38042
-
France
Novartis Investigative Site
Recruiting
Lille Cedex, 59037
-
France
Novartis Investigative Site
Recruiting
Nice Cedex, 06202
-
France
Novartis Investigative Site
Recruiting
Nimes, 30029
-
France
Novartis Investigative Site
Recruiting
Suresnes, 92150
-
France
Novartis Investigative Site
Recruiting
Toulouse Cedex 9, 31059
-
France
Greece
Novartis Investigative Site
Recruiting
Ioannina, 455 00
GR
Greece
Novartis Investigative Site
Recruiting
Amyntaio, 53246
-
Greece
India
Novartis Investigative Site
Recruiting
Pune, 411013
Maharashtra
India
Novartis Investigative Site
Recruiting
Kolkata, 700017
West Bengal
India
Italy
Novartis Investigative Site
Recruiting
Firenze,
FI
Italy
Novartis Investigative Site
Recruiting
Pozzilli, 86077
IS
Italy
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Mexico
Novartis Investigative Site
Recruiting
Ciudad de Mexico, 06700
Distrito Federal
Mexico
Poland
Novartis Investigative Site
Recruiting
Katowice, 40 571
-
Poland
Novartis Investigative Site
Recruiting
Zabrze, 41-800
-
Poland
Portugal
Novartis Investigative Site
Recruiting
Matosinhos, 4454509
Porto
Portugal
Novartis Investigative Site
Recruiting
Braga, 4710243
-
Portugal
Puerto Rico
Novartis Investigative Site
Recruiting
Guaynabo, 00968
-
Puerto Rico
Slovakia
Novartis Investigative Site
Recruiting
Banska Bystrica, 974 04
-
Slovakia
Novartis Investigative Site
Recruiting
Banska Bystrica, 975 17
-
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 83305
-
Slovakia
Slovenia
Novartis Investigative Site
Recruiting
Celje, 3000
-
Slovenia
Novartis Investigative Site
Recruiting
Ljubljana, 1000
-
Slovenia
Novartis Investigative Site
Recruiting
Maribor, 2000
-
Slovenia
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
Recruiting
Gijon, 33394
Asturias
Spain
Novartis Investigative Site
Recruiting
Hospitalet de Llobregat, 08907
Barcelona
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Recruiting
Valencia, 46017
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Santiago de Compostela, 15706
Galicia
Spain
Novartis Investigative Site
Recruiting
Torrejon de Ardoz, 28850
Madrid
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28040
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
-
Spain
Sweden
Novartis Investigative Site
Recruiting
Stockholm, 141 86
-
Sweden
Turkey
Novartis Investigative Site
Recruiting
Sancaktepe, 34785
Istanbul
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34093
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35620
-
Turkey
Novartis Investigative Site
Recruiting
Kocaeli, 41380
-
Turkey
Novartis Investigative Site
Recruiting
Samsun, 55139
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]