Last updated 3 months ago
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
800 patients around the world
Available in Argentina, United States, Spain
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.
Novartis Pharmaceuticals
2Research sites
800Patients around the world
This study is for people with
Multiple sclerosis
Relapsing remitting multiple sclerosis
Requirements for the patient
To 55 Years
All Gender
Medical requirements
- 18 to 55 years of ageDiagnosis of RMS according to the 2017 McDonald diagnostic criteriaAt 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
- Diagnosis of primary progressive multiple sclerosis (PPMS)Disease duration of more than 10 years in participants with EDSS score of 2 or less at screeningHistory of clinically significant CNS disease other than MSOngoing 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 PMLsuicidal ideation or behaviorEvidence 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 adherenceParticipants who have had a splenectomyActive clinically significant systemic bacterial, viral, parasitic or fungal infectionsPositive results for syphilis or tuberculosis testingUncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroidsActive, 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 antibodyHistory 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 levelParticipants at risk of developing or having reactivation of hepatitisHematology 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 abnormalitiesResting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment (prior to randomization)Use of other investigational drugsRequirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,History of gastrointestinal bleedingMajor surgery within 8 weeks prior to screeningHistory of hypersensitivity to any of the study drugs or excipientsPregnant or nursing (lactating) female participants, prior to randomizationWomen of childbearing potential not using highly effective contraceptionSexually active males not agreeing to use condomHave received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during studyUse of strong CYP3A4 inhibitors or strong CYP3A4 inducers within two weeks prior to randomization
Sites
STAT Research - CABA
Recruiting
Instituto de Neurología Cognitiva (INECO)
Recruiting
StudyREMODEL-1
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Relapsing remitting multiple sclerosis
Requirements
To 55 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05147220
