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

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: NCT05147220

Novartis Reference Number: CLOU064C12301

Last Update: Nov 14, 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 16, 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
Fort Smith, 72916
Arkansas
United States
Novartis Investigative Site
Recruiting
Fullerton, 92835
California
United States
Novartis Investigative Site
Recruiting
Newark, 19713
Delaware
United States
Novartis Investigative Site
Recruiting
Altamonte Springs, 32714
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33032
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33175
Florida
United States
Novartis Investigative Site
Recruiting
Orlando, 32806
Florida
United States
Novartis Investigative Site
Recruiting
Orlando, 32825
Florida
United States
Novartis Investigative Site
Recruiting
Ormond Beach, 32174
Florida
United States
Novartis Investigative Site
Recruiting
Port Charlotte, 33952
Florida
United States
Novartis Investigative Site
Recruiting
Saint Petersburg, 33709
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33612
Florida
United States
Novartis Investigative Site
Recruiting
Honolulu, 96817
Hawaii
United States
Novartis Investigative Site
Recruiting
Overland Park, 66210
Kansas
United States
Novartis Investigative Site
Recruiting
Bethesda, 20817
Maryland
United States
Novartis Investigative Site
Recruiting
Billings, 59101
Montana
United States
Novartis Investigative Site
Recruiting
Charlotte, 28204
North Carolina
United States
Novartis Investigative Site
Recruiting
Westerville, 43082
Ohio
United States
Novartis Investigative Site
Recruiting
Summerville, 29485
South Carolina
United States
Novartis Investigative Site
Recruiting
Bellaire, 77401
Texas
United States
Novartis Investigative Site
Recruiting
Dallas, 75390-9034
Texas
United States
Novartis Investigative Site
Recruiting
McAllen, 78503
Texas
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84132
Utah
United States
Novartis Investigative Site
Recruiting
Vienna, 22182
Virginia
United States
Novartis Investigative Site
Recruiting
Neenah, 54956
Wisconsin
United States
Argentina
Novartis Investigative Site
Recruiting
Capital Federal, 1424
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1012AAR
-
Argentina
Novartis Investigative Site
Recruiting
Caba, C1424BYD
-
Argentina
Novartis Investigative Site
Recruiting
Capital Federal, C1023AAB
-
Argentina
Belgium
Novartis Investigative Site
Recruiting
Ath, 7800
-
Belgium
Novartis Investigative Site
Recruiting
Melsbroek, 1820
-
Belgium
Bulgaria
Novartis Investigative Site
Recruiting
Pleven, 5800
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1431
-
Bulgaria
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Tianjin, 300052
-
China
Croatia
Novartis Investigative Site
Recruiting
Zagreb, 10000
-
Croatia
Hong Kong
Novartis Investigative Site
Recruiting
Hong Kong,
-
Hong Kong
India
Novartis Investigative Site
Recruiting
New Delhi, 110017
Delhi
India
Novartis Investigative Site
Recruiting
Ludhiana, 141008
Punjab
India
Novartis Investigative Site
Recruiting
DehraDun, 248001
Uttarakhand
India
Italy
Novartis Investigative Site
Recruiting
Montichiari, 25018
BS
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Recruiting
Roma, 00133
RM
Italy
Novartis Investigative Site
Recruiting
Verona, 37134
VR
Italy
Latvia
Novartis Investigative Site
Recruiting
Riga, LV 1002
-
Latvia
Malaysia
Novartis Investigative Site
Recruiting
Seberang Jaya, 13700
Pulau Pinang
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 50589
-
Malaysia
Poland
Novartis Investigative Site
Recruiting
Kielce, 25 726
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90 324
-
Poland
Slovakia
Novartis Investigative Site
Recruiting
Kosice, 04066
Slovak Republic
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 82606
-
Slovakia
Novartis Investigative Site
Recruiting
Nitra, 94901
-
Slovakia
Novartis Investigative Site
Recruiting
Trnava, 917 75
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
Recruiting
Salt, 17190
Cataluna
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Recruiting
Getafe, 28905
Madrid
Spain
Novartis Investigative Site
Recruiting
El Palmar, 30120
Murcia
Spain
Novartis Investigative Site
Recruiting
Baracaldo, 48903
Vizcaya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
-
Spain
Novartis Investigative Site
Recruiting
Leon, 24080
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28040
-
Spain
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4031
-
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3010
-
Switzerland

Contacts

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

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