Multiple Sclerosis Clinical Trial
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis
Summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis
Full Description
The study CLOU064C12301 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 (CLOU064C12302) 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 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 149 Locations for this study
Scottsdale Arizona, 85258, United States
Tucson Arizona, 85718, United States
Fort Smith Arkansas, 72916, United States
Berkeley California, 94705, United States
Chula Vista California, 91910, United States
Fullerton California, 92835, United States
Glendale California, 91206, United States
Newport Beach California, 92663, United States
Basalt Colorado, 81621, United States
Boulder Colorado, 80301, United States
Newark Delaware, 19713, United States
Altamonte Springs Florida, 32714, United States
Miami Florida, 33032, United States
Miami Florida, 33175, United States
Orlando Florida, 32806, United States
Orlando Florida, 32825, United States
Ormond Beach Florida, 32174, United States
Port Charlotte Florida, 33952, United States
Seminole Florida, 33777, United States
Tampa Florida, 33609, United States
Tampa Florida, 33612, United States
Savannah Georgia, 31406, United States
Honolulu Hawaii, 96817, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60616, United States
Park Ridge Illinois, 60068, United States
Fort Wayne Indiana, 46845, United States
Overland Park Kansas, 66210, United States
Bethesda Maryland, 20817, United States
Lutherville Maryland, 21093, United States
Foxboro Massachusetts, 02035, United States
Saint Louis Missouri, 63131, United States
Billings Montana, 59101, United States
Charlotte North Carolina, 28204, United States
Raleigh North Carolina, 27607, United States
Westerville Ohio, 43082, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Reading Pennsylvania, 19611, United States
Summerville South Carolina, 29485, United States
Dallas Texas, 75206, United States
Dallas Texas, 75390, United States
El Paso Texas, 79912, United States
Houston Texas, 77074, United States
McAllen Texas, 78503, United States
Salt Lake City Utah, 84132, United States
Vienna Virginia, 22182, United States
Seattle Washington, 98122, United States
Madison Wisconsin, 53792, United States
Neenah Wisconsin, 54956, United States
Caba Buenos Aires, C1122, Argentina
Capital Federal Buenos Aires, 1424, Argentina
Rosario Santa Fe, 2000, Argentina
Buenos Aires , C1012, Argentina
Caba , C1424, Argentina
Capital Federal , C1023, Argentina
Edegem Antwerpen, 2650, Belgium
Jette Brussel, 1090, Belgium
Antwerpen , 2018, Belgium
Ath , 7800, Belgium
Brasschaat , 2930, Belgium
Brugge , 8000, Belgium
Lier , 2500, Belgium
Melsbroek , 1820, Belgium
Pelt , 3900, Belgium
Pleven , 5800, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1431, Bulgaria
Santiago Region Metropolitana, 76505, Chile
Santiago Region Metropolitana, 84316, Chile
Beijing Beijing, 10000, China
Guangzhou City Guangdong, 51000, China
Guangzhou Guangdong, 51008, China
Zhengzhou Henan, 45005, China
Changsha Hunan, 41000, China
Baotou Inner Mongolia, 01404, China
Hohhot Inner Mongolia, 01001, China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13002, China
Beijing , 10002, China
Beijing , 10073, China
Chongqing , 40001, China
Tianjin , 30005, China
Puerto Colombia Atlantico, 08001, Colombia
Cali Valle Del Cauca, 76000, Colombia
Cali Valle Del Cauca, 76001, Colombia
Bogota , 11011, Colombia
Rijeka HRV, 51000, Croatia
Osijek , 31000, Croatia
Zadar , 23000, Croatia
Zagreb , 10000, Croatia
Slagelse , DK-42, Denmark
Guatemala , 01015, Guatemala
Sha Tin , , Hong Kong
New Delhi Delhi, 11001, India
Mumbai Maharashtra, 40000, India
Nashik Maharashtra, 42200, India
Chandigarh Punjab, 16001, India
Ludhiana Punjab, 14100, India
Hyderabad Telangana, 50008, India
Lucknow Uttar Pradesh, 22601, India
DehraDun Uttarakhand, 24800, India
Dublin 4 , DO4, Ireland
Dublin , DUBLI, Ireland
Montichiari BS, 25018, Italy
Milano MI, 20132, Italy
Roma RM, 00133, Italy
Roma RM, 00168, Italy
Verona VR, 37134, Italy
Napoli , 80131, Italy
Riga LV, LV-10, Latvia
Riga , LV 10, Latvia
El Chouf LBN, 15032, Lebanon
Beirut , 6301, Lebanon
Seberang Jaya Pulau Pinang, 13700, Malaysia
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