Study Description
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) The study CLOU064C12302 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 (CLOU064C12301) will be conducted simultaneously. Both
studies will be conducted globally and data from the two studies will be pooled for some
of the endpoints.
Interventions
Remibrutinib
Teriflunomide
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 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 Location
Novartis Investigative Site
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Caba,Buenos Aires,C1181ach,Argentina
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San Miguel De,Tucuman,T4000,Argentina
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Buenos Aires,C1012aar,Argentina
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Bombal,Mendoza,M5500dxo,Argentina
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Rosario,Santa Fe,S2000bzl,Argentina
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Rosario,Santa Fe,S2000dsw,Argentina
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Curitiba,PR,81210-310,Brazil
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Sao Paulo,01240-020,Brazil
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Porto Alegre,Rio Grande Do Sul,90035-001,Brazil
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Porto Alegre,RS,90110-000,Brazil
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Joinville,Santa Catarina,89202-165,Brazil
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Porto Alegre,RS,90430-001,Brazil
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Vitoria,ES,29055-450,Brazil
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Brasilia,DF,70200-730,Brazil
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Sofia,1309,Bulgaria
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Sofia,1407,Bulgaria
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Sofia,1413,Bulgaria
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Plovdiv,4002,Bulgaria
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Levis,Quebec,G6w 0m5,Canada
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St Jerome,Quebec,J7z 5t3,Canada
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Halifax,Nova Scotia,B3h 4k4,Canada
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Ottawa,Ontario,K1h 8l6,Canada
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Montreal,Quebec,H4a 3t2,Canada
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Edmonton,Alberta,T6g 2b7,Canada
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Quebec,G1j 1z4,Canada
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Burnaby,British Columbia,V5g 2x6,Canada
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Taiyuan,Shanxi,030001,China
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Beijing,100034,China
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Fuzhou,Fujian,350025,China
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Wenzhou,Zhejiang,325000,China
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Hangzhou,Zhejiang,310006,China
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Hangzhou,Zhejiang,310016,China
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Wuhan,Hubei,430030,China
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Wuhan,Hubei,430060,China
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Shanghai,200025,China
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Nanjing,Jiangsu,210029,China
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Yinchuan,Ningxia,100039,China
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Shanghai,200040,China
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Vukovar,32000,Croatia
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Zagreb,10000,Croatia
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Varazdin,HRV,42000,Croatia
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Split,HRV,21000,Croatia
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Tallinn,11315,Estonia
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Tartu,50406,Estonia
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Nantes,Cedex 1,44093,France
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Grenoble,38042,France
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Poissy,78303,France
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Toulouse Cedex 9,31059,France
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Caen,14033,France
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Dijon,21034,France
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Clermont-Ferrand Cedex 1,63003,France
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Nice,06202,France
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Lille,59000,France
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Marseille,13003,France
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Gonesse,95500,France
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Lille,59037,France
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Nimes,30029,France
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Limoges,87042,France
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Suresnes,92150,France
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Toulon Cedex 9,Val De Marne,83800,France
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Contamine Sur Arve,74130,France
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Athens,Attica,11526,Greece
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Athens,115 28,Greece
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Athens,12462,Greece
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Ioannina,GR,455 00,Greece
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Thessaloniki,Gr 54636,Greece
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Larissa,GR,411 10,Greece
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Greece,53246,Greece
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Kolkata,West Bengal,700017,India
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Pune,Maharashtra,411004,India
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Pune,Maharashtra,411013,India
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New Delhi,Delhi,110 060,India
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Kochi,Kerala,682025,India
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Lucknow,Uttar Pradesh,226007,India
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Amritsar,Punjab,143006,India
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Hyderabad,Telangana,500082,India
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Messina,ME,98121,Italy
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Orbassano,TO,10043,Italy
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Napoli,80131,Italy
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Modena,MO,41126,Italy
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Pavia,PV,27100,Italy
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Brindisi,BR,72100,Italy
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Firenze,FI,50134,Italy
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Foggia,FG,71100,Italy
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Pozzilli,IS,86077,Italy
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Shinjuku ku,Tokyo,162 8666,Japan
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Itabashi-ku,Tokyo,173-8610,Japan
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Fukuoka,810-0022,Japan
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Ichihara-city,Chiba,299-0111,Japan
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Shinjuku-ku,Tokyo,160 8582,Japan
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Sagamihara,Kanagawa,252-0375,Japan
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Koriyama city,Fukushima,963-8052,Japan
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Sapporo city,Hokkaido,063-0005,Japan
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Shinjuku-ku,Tokyo,160-0023,Japan
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Sendai city,Miyagi,983 8512,Japan
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Kobe-shi,Hyogo,650-0017,Japan
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Moriguchi,Osaka,570-8507,Japan
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Kyoto-city,Kyoto,616-8255,Japan
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Isehara,Kanagawa,259-1193,Japan
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Niigata,951 8520,Japan
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Higashimatsuyama,Saitama,355-0005,Japan
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Kashihara city,Nara,634 8522,Japan
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Nagoya,Aichi,466 8560,Japan
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Suita,Osaka,565 0871,Japan
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Chiba,2608677,Japan
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Kodaira,Tokyo,187-8551,Japan
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Fukuoka city,Fukuoka,812-8582,Japan
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Nishinomiya,Hyogo,663 8501,Japan
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Ciudad de Mexico,Distrito Federal,06700,Mexico
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Ciudad De Mexico,14050,Mexico
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Queretaro,76070,Mexico
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Chihuahua,31203,Mexico
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Zabrze,41-800,Poland
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Katowice,40-123,Poland
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Bialystok,15-704,Poland
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Wroclaw,51-685,Poland
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Krakow,31-637,Poland
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Glogow,36-060,Poland
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Plewiska,Poznan,62-064,Poland
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Katowice,40 571,Poland
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Katowice,40-081,Poland
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Lisboa,1169 050,Portugal
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Lisboa,1649 035,Portugal
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Coimbra,3000 075,Portugal
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Matosinhos,Porto,4454509,Portugal
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Braga,4710243,Portugal
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Leiria,2410-104,Portugal
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Santa Maria da Feira,4520 211,Portugal
Caribbean Center for Clinical Research, Inc. .
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Guaynabo,00968,Puerto Rico
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Brasov,ROM,500123,Romania
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Campulung Muscel,115100,Romania
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Targu Mures,540136,Romania
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Suceava,727525,Romania
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Constanta,900591,Romania
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Constanta,ROM,900123,Romania
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Bratislava,83305,Slovakia
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Banska Bystrica,974 04,Slovakia
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Banska Bystrica,975 17,Slovakia
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Ljubljana,1000,Slovenia
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Maribor,2000,Slovenia
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Celje,3000,Slovenia
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Rosebank,2196,South Africa
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Bloemfontein,Free State,9301,South Africa
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Pretoria,0041,South Africa
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Santiago De Compostela,Galicia,15706,Spain
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Barcelona,08041,Spain
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Madrid,28040,Spain
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Valencia,Comunidad Valenciana,46017,Spain
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Malaga,29016,Spain
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Gijon,Asturias,33394,Spain
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Valencia,46026,Spain
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Logrono,La Rioja,26006,Spain
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Sevilla,Andalucia,41009,Spain
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Pozuelo de Alarcon,Madrid,28223,Spain
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Albacete,Castilla La Mancha,02006,Spain
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Vitoria Gasteiz,Pais Vasco,01009,Spain
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Hospitalet de Llobregat,Barcelona,08907,Spain
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Torrejon de Ardoz,Madrid,28850,Spain
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Barcelona,Catalunya,08003,Spain
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Madrid,28009,Spain
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Stockholm,102 35,Sweden
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Stockholm,141 86,Sweden
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Izmir,35340,Turkey
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Kayseri,38280,Turkey
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Izmir,35620,Turkey
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Samsun,55139,Turkey
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Pendik Istanbul,34899,Turkey
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Kocaeli,41380,Turkey
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Sancaktepe,Istanbul,34785,Turkey
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Istanbul,34093,Turkey
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Bursa,16140,Turkey
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Istanbul,TUR,34098,Turkey
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Meram,42005,Turkey
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Inverness,Invernesshire,Iv2 3re,United Kingdom
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Canterbury,Kent,Ct1 3ng,United Kingdom
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London,W1g 9jf,United Kingdom
Conquest Research
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Winter Park,Florida,32789,United States
University of Kansas Medical Center CFTY720D2399E1
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Kansas City,Kansas,66160-7330,United States
Med Research Inc
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El Paso,Texas,79935,United States
Baptist Physicians Lexington .
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Nicholasville,Kentucky,40356,United States
Georgia Neurology and Sleep Medicine Assoc
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Suwanee,Georgia,30024,United States
South Shore Neurologic Associates CFTY720D2403
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Patchogue,New York,11772,United States
Neurology Associates, PA
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Maitland,Florida,32751,United States
Ctr for Neurology and Spine
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Phoenix,Arizona,85018,United States
Medical College of Wisconsin
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Milwaukee,Wisconsin,53226,United States
University of Miami Miller School of Medicine .
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Miami,Florida,33136,United States
Brain and Spine Institute
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Port Orange,Florida,32127,United States
Hope Neurology
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Knoxville,Tennessee,37922,United States
Texas Institute for Neurological Disorders
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Sherman,Texas,75092,United States
Neurology Consultants Of Dallas PA Research
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Dallas,Texas,75231,United States
CU Anschutz Med Campus
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Aurora,Colorado,80045,United States
Ochsner Clinic Foundation .
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New Orleans,Louisiana,70121,United States
Medical Uni of South Carolina Medical Univ of SC
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Charleston,South Carolina,29425,United States
University of Texas Health Science Center San Antonio COMB157G2301
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San Antonio,Texas,78229,United States
Humanity Clinical Research .
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Pembroke Pines,Florida,33024,United States
The Boster Ctr for MS
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Columbus,Ohio,43235,United States
Neurology Diagnostics Inc .
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Dayton,Ohio,45408,United States
Advent Health Orlando
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Orlando,Florida,32803,United States
Piedmont HealthCare
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Charlotte,North Carolina,28210,United States
Elligo Health Research
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Crab Orchard,West Virginia,25827,United States
Memorial Healthcare .
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Owosso,Michigan,48867,United States
University of Washington MS Clinic
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Seattle,Washington,98133,United States
Colorado Neurological Research PC
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Denver,Colorado,80210,United States
True North Neurology .
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Port Jefferson Station,New York,11776,United States
Kansas City VA Medical Center
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Kansas City,Missouri,64128,United States
Nova Clinical Research LLC .
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Bradenton,Florida,34209,United States
Aqualane Clinical Research .
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Naples,Florida,34102,United States
Premier Neurology
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Greenville,South Carolina,29650,United States
Emerald Coast Neurology .
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Pensacola,Florida,32514,United States
Vero Beach Neurology .
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Vero Beach,Florida,32960,United States
Memorial Hospital .
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Hollywood,Florida,33021,United States
Colorado Springs Neurological Associates
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Colorado Springs,Colorado,80907,United States
Tufts Medical Center .
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Boston,Massachusetts,02111,United States
Lone Star Neurology
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Frisco,Texas,75035,United States
Ascension St Francis Center
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Milwaukee,Wisconsin,53215,United States
Regina Berkovich MD PhD Inc
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West Hollywood,California,90048,United States
Gables Neurology
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Miami,Florida,33133,United States
Virginia Mason Medical Centre Benaroya Research Institute-2
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Seattle,Washington,98101,United States
Methodist Neuroscience Institute
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Merrillville,Indiana,46410,United States
Comprehensive Neurology
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Frederick,Maryland,21702,United States
Univ of Florida College of Medicine Norman Fixel Institute
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Gainesville,Florida,32610,United States
Lonestar Neurology of San Antonio
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San Antonio,Texas,78258,United States
Aurora BayCare Medical Center
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Green Bay,Wisconsin,54311,United States
SFM Clinical Research LLC
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Boca Raton,Florida,33487,United States
Georgetown University Hospital Research
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Washington,District of Columbia,20007,United States
Vladimir Royter MD APMC
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Hanford,California,93230,United States
Metrolina Neurological Associates PA .
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Indian Land,South Carolina,29707,United States
Worldwide Contacts
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