Study Description
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) 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.
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 (including all Child-Pugh classes) or hepatic
failure 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 as per central
ECG reading at screening visit
- 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
Neurological Services of Orlando PA
Recruiting
Orlando,Florida,32806,United States
Amparo Gutierrez
Daniel H Jacobs
Beth Israel Deaconess Medical Cente
Recruiting
Boston,Massachusetts,02215,United States
Jacob Sloane
Neur Ctr of N Orange County
Recruiting
Fullerton,California,92835,United States
Anthony Ciabarra
Sheraz Mossa
Hoag Health System
Recruiting
Newport Beach,California,92663,United States
Yasir Jassam
Springfield Clinic Research
Recruiting
Springfield,Illinois,62703,United States
Sue Sutherland
Reuben Valenzuela
Mid Atlantic Epilepsy and Sleep Ctr
Recruiting
Bethesda,Maryland,20817,United States
Jonathan Ross
Alpine Clinical Research Center
Recruiting
Boulder,Colorado,80301,United States
Sidarth Dasari
Velocity Clinical Research Drug Shipment
Recruiting
Raleigh,North Carolina,27607,United States
Casey Jeffreys
Rush University Medical Center CFTY720D2312
Recruiting
Chicago,Illinois,60612,United States
Thomas Shoemaker
College Park Family Care Center
Recruiting
Overland Park,Kansas,66210,United States
Jeffrey Kaplan
International Neurorehab Institute .
Recruiting
Lutherville,Maryland,21093,United States
Daniel Becker
Accel Research Sites St Pete-Largo
Recruiting
Seminole,Florida,33777,United States
Deborah Burke
Patricia Hanson
The Research and Education Inst. of Alta Bates Summit Med. Grp
Recruiting
Berkeley,California,94705,United States
Deepak Soneji
The MS Center for Innovation in Care .
Recruiting
Saint Louis,Missouri,63131,United States
Barry A Singer
Homestead Associates in Research Inc
Recruiting
Miami,Florida,33032,United States
Angel Carrasco
Norton Neurology MS Services
Recruiting
Louisville,Kentucky,40207,United States
Geeta Ganesh
Neurology Associates of Ormond Beach
Recruiting
Ormond Beach,Florida,32174,United States
James Scott
SC3 Research Pasadena
Recruiting
Pasadena,California,91105,United States
M Lorraine Purino
Comprehensive Neurology Clinic
Recruiting
Orlando,Florida,32825,United States
Refaat El-Said
Neurological Associates of Long Island PC
Recruiting
Lake Success,New York,11042,United States
Teresa DeAngelis
Center for Neurosciences
Recruiting
Tucson,Arizona,85718,United States
Francisco Valdivia
Washington Hospital Center Research Site Shipment
Recruiting
Washington,District of Columbia,20010,United States
Brian Barry
Mountain Neuro Research Center PC .
Recruiting
Basalt,Colorado,81621,United States
Alison Brooke Allen
Leslia Serrano
Axiom Clinical Research of Florida
Recruiting
Tampa,Florida,33609,United States
Mark Cascione
Advocate Medical Group
Recruiting
Park Ridge,Illinois,60068,United States
Danielle Rice
University Of South Florida .
Recruiting
Tampa,Florida,33612,United States
Derrick Robertson
Jersey Shore University Medical Ctr
Recruiting
Neptune,New Jersey,07753,United States
Lana Zhovtis Ryerson
The Neurological Institute PA
Recruiting
Charlotte,North Carolina,28204,United States
T Hemanth Hemanth Rao
Honor Health Research Institute .
Recruiting
Scottsdale,Arizona,85258,United States
Marissa Bielecki
Suraj Muley
NYU Langone Med Center CV Research .
Recruiting
New York,New York,10016,United States
Nada Abou-Fayssal
Neurology Center of New England PC .
Recruiting
Foxboro,Massachusetts,02035,United States
Salvatore Napoli
SCL Health
Recruiting
Billings,Montana,59101,United States
Amanda Klein
Kristian French
Glendale Adventist Medical Center Research
Recruiting
Glendale,California,91206,United States
Artin Minaeian
Reliant Medical Research
Recruiting
Miami,Florida,33165,United States
Carlos Ramirez-Calderon
Christiana Care Health Services
Recruiting
Newark,Delaware,19713,United States
Jason M Silversteen
AZ Integrated Neuro and Spine Integrated MS Center
Recruiting
Phoenix,Arizona,85037,United States
Barry Hendin
Brandon Mc Cravey
Multiple Sclerosis Center of Excellence of OMRF
Recruiting
Oklahoma City,Oklahoma,73104,United States
Gabriel Pardo
Neurology of Central FL Res Ctr
Recruiting
Altamonte Springs,Florida,32714,United States
Alicia Cabrera
Allied Physicians Inc .
Recruiting
Fort Wayne,Indiana,46845,United States
Ajay Gupta
Olivia Vincent
Velocity Clinical Research
Recruiting
Savannah,Georgia,31406,United States
J Michael Hemphill
Lahey Clinic
Recruiting
Burlington,Massachusetts,01805,United States
Dan Michael Pineda
The Neuron Clinic .
Recruiting
Chula Vista,California,91910,United States
Jose Soria
Insight Hospital and Medical Center
Recruiting
Chicago,Illinois,60616,United States
Agatha Ngwueke
Rany A Aburashed
NYU Langone Research
Recruiting
Brooklyn,New York,11201,United States
Josef Gutman
Worldwide Contacts
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