Multiple Sclerosis Clinical Trial
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis
Full Description
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.
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:
• 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
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There are 186 Locations for this study
Hanford California, 93230, United States
Aurora Colorado, 80045, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80210, United States
Boca Raton Florida, 33487, United States
Bradenton Florida, 34209, United States
Gainesville Florida, 32610, United States
Hollywood Florida, 33021, United States
Maitland Florida, 32751, United States
Miami Florida, 33136, United States
Naples Florida, 34102, United States
Orlando Florida, 32803, United States
Pembroke Pines Florida, 33024, United States
Pensacola Florida, 32514, United States
Port Orange Florida, 32127, United States
Vero Beach Florida, 32960, United States
Winter Park Florida, 32789, United States
Suwanee Georgia, 30024, United States
Merrillville Indiana, 46410, United States
Kansas City Kansas, 66160, United States
New Orleans Louisiana, 70121, United States
Frederick Maryland, 21702, United States
Boston Massachusetts, 02111, United States
Owosso Michigan, 48867, United States
Kansas City Missouri, 64128, United States
Patchogue New York, 11772, United States
Charlotte North Carolina, 28210, United States
Columbus Ohio, 43235, United States
Dayton Ohio, 45408, United States
Greer South Carolina, 29650, United States
Indian Land South Carolina, 29707, United States
Knoxville Tennessee, 37922, United States
El Paso Texas, 79935, United States
Frisco Texas, 75035, United States
Houston Texas, 77094, United States
San Antonio Texas, 78229, United States
Sherman Texas, 75092, United States
Seattle Washington, 98133, United States
Crab Orchard West Virginia, 25827, United States
Green Bay Wisconsin, 54311, United States
Milwaukee Wisconsin, 53226, United States
Bombal Mendoza, M5500, Argentina
Rosario Santa Fe, S2000, Argentina
San Miguel De Tucuman, T4000, Argentina
Buenos Aires , C1012, Argentina
Brasilia DF, 70200, Brazil
Vitoria ES, 29055, Brazil
Curitiba PR, 81210, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre RS, 90110, Brazil
Porto Alegre RS, 90430, Brazil
Joinville Santa Catarina, 89202, Brazil
Sao Paulo , 01240, Brazil
Plovdiv , 4002, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1413, Bulgaria
Edmonton Alberta, T6G 2, Canada
Halifax Nova Scotia, B3H 4, Canada
Ottawa Ontario, K1H 8, Canada
Greenfield Park Quebec, J4V 2, Canada
Levis Quebec, G6W 0, Canada
Fuzhou Fujian, 35002, China
Wuhan Hubei, 43003, China
Wuhan Hubei, 43006, China
Nanjing Jiangsu, 21002, China
Yinchuan Ningxia, 10003, China
Taiyuan Shanxi, 03000, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
Wenzhou Zhejiang, 32500, China
Shanghai , 20002, China
Shanghai , 20004, China
Split HRV, 21000, Croatia
Varazdin HRV, 42000, Croatia
Vukovar , 32000, Croatia
Zagreb , 10000, Croatia
Tallinn , 11315, Estonia
Tartu , 51014, Estonia
Nantes Cedex 1, 44093, France
Toulon Cedex 9 Val De Marne, 83800, France
CAEN Cedex , 14033, France
Clermont-Ferrand Cedex 1 , 63003, France
Contamine Sur Arve , 74130, France
Dijon , 21034, France
Gonesse , 95500, France
Grenoble , 38042, France
Lille Cedex , 59037, France
Lille , 59000, France
Nice Cedex , 06202, France
Nimes , 30029, France
Suresnes , 92150, France
Toulouse Cedex 9 , 31059, France
Athens Attica, 11526, Greece
Ioannina GR, 455 0, Greece
Larissa GR, 411 1, Greece
Amyntaio , 53246, Greece
Athens , 115 2, Greece
Athens , 12462, Greece
Thessaloniki , GR 54, Greece
New Delhi Delhi, 110 0, India
Pune Maharashtra, 41101, India
Amritsar Punjab, 14300, India
Hyderabad Telangana, 50008, India
Lucknow Uttar Pradesh, 22600, India
Kolkata West Bengal, 70001, India
Brindisi BR, 72100, Italy
Foggia FG, 71100, Italy
Firenze FI, 50134, Italy
Pozzilli IS, 86077, Italy
Messina ME, 98121, Italy
Modena MO, 41126, Italy
Pavia PV, 27100, Italy
Orbassano TO, 10043, Italy
Napoli , 80131, Italy
Nagoya Aichi, 466 8, Japan
Fukuoka city Fukuoka, 812-8, Japan
Koriyama city Fukushima, 963-8, Japan
Sapporo city Hokkaido, 063-0, Japan
Kobe-shi Hyogo, 650-0, Japan
Nishinomiya Hyogo, 663 8, Japan
Isehara Kanagawa, 259-1, Japan
Kyoto-city Kyoto, 616-8, Japan
Sendai city Miyagi, 983 8, Japan
Kashihara city Nara, 634 8, Japan
Moriguchi Osaka, 570-8, Japan
Suita Osaka, 565 0, Japan
Kodaira Tokyo, 187-8, Japan
Shinjuku-ku Tokyo, 160 8, Japan
Shinjuku-ku Tokyo, 160-0, Japan
Chiba , 260 8, Japan
Fukuoka , 810-0, Japan
Niigata , 951 8, Japan
Ciudad de Mexico Distrito Federal, 06700, Mexico
Chihuahua , 31203, Mexico
Ciudad De Mexico , 14050, Mexico
Queretaro , 76070, Mexico
Plewiska Poznan, 62-06, Poland
Bialystok , 15-70, Poland
Katowice , 40 57, Poland
Katowice , 40-12, Poland
Krakow , 31-63, Poland
Wroclaw , 51-68, Poland
Zabrze , 41-80, Poland
Matosinhos Porto, 44545, Portugal
Braga , 47102, Portugal
Leiria , 2410-, Portugal
Lisboa , 16001, Portugal
Santa Maria da Feira , 4520 , Portugal
Guaynabo , 00968, Puerto Rico
Campulung Muscel ROM, 11510, Romania
Constanta ROM, 90012, Romania
Constanta , 90059, Romania
Targu Mures , 54013, Romania
Banska Bystrica , 974 0, Slovakia
Banska Bystrica , 975 1, Slovakia
Bratislava , 83305, Slovakia
Celje , 3000, Slovenia
Ljubljana , 1000, Slovenia
Maribor , 2000, Slovenia
Bloemfontein Free State, 9301, South Africa
Pretoria , 0041, South Africa
Rosebank , 2196, South Africa
Sevilla Andalucia, 41009, Spain
Gijon Asturias, 33394, Spain
Hospitalet de Llobregat Barcelona, 08907, Spain
Barcelona Catalunya, 08003, Spain
Valencia Comunidad Valenciana, 46017, Spain
Santiago de Compostela Galicia, 15706, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Torrejon de Ardoz Madrid, 28850, Spain
Vitoria-Gasteiz PaÃs Vasco, 01009, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
Valencia , 46026, Spain
Stockholm , 102 3, Sweden
Stockholm , 141 8, Sweden
Sancaktepe Istanbul, 34785, Turkey
Bursa , 16140, Turkey
Istanbul , 34093, Turkey
Izmir , 35620, Turkey
Kayseri , 38280, Turkey
Kocaeli , 41380, Turkey
Pendik Istanbul , 34899, Turkey
Samsun , 55139, Turkey
London , W1G 9, United Kingdom
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