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
Med Research Inc
Recruiting
El Paso,Texas,79935,United States
Javier Alejandro Vasallo
Texas Institute for Neurological Disorders
Recruiting
Sherman,Texas,75092,United States
Bharathy Sundaram
Colorado Neurological Research PC
Recruiting
Denver,Colorado,80210,United States
Adam Wolff
University of Texas Health Science Center San Antonio COMB157G2301
Recruiting
San Antonio,Texas,78229,United States
Charlotte Rhodes
Rebecca Romero
Emerald Coast Neurology .
Recruiting
Pensacola,Florida,32514,United States
David Bear
Neurology Consultants Of Dallas PA Research
Recruiting
Dallas,Texas,75231,United States
Melissa Cardoza
Adnan Subei
Kansas City VA Medical Center
Recruiting
Kansas City,Missouri,64128,United States
Vikas Singh
Regina Berkovich MD PhD Inc
Recruiting
West Hollywood,California,90048,United States
Regina Berkovich
Aurora BayCare Medical Center
Recruiting
Green Bay,Wisconsin,54311,United States
James Napier
Methodist Neuroscience Institute
Recruiting
Merrillville,Indiana,46410,United States
William Conte
Univ of Florida College of Medicine Norman Fixel Institute
Recruiting
Gainesville,Florida,32610,United States
Torge Rempe
Ctr for Neurology and Spine
Recruiting
Phoenix,Arizona,85018,United States
Leslie Zuniga
Virginia Mason Medical Centre Benaroya Research Institute-2
Recruiting
Seattle,Washington,98101,United States
Yeojin Yoon
Mariko Kita
Georgia Neurology and Sleep Medicine Assoc
Recruiting
Suwanee,Georgia,30024,United States
David Lesch
Ochsner Clinic Foundation .
Recruiting
New Orleans,Louisiana,70121,United States
Jenny Feng
Medical Uni of South Carolina Medical Univ of SC
Recruiting
Charleston,South Carolina,29425,United States
Andrew P Keegan
The Boster Ctr for MS
Recruiting
Columbus,Ohio,43235,United States
Aaron Boster
Colorado Springs Neurological Associates
Recruiting
Colorado Springs,Colorado,80907,United States
Kimberly Wagner
Neurology Diagnostics Inc .
Recruiting
Dayton,Ohio,45408,United States
Joel Vandersluis
Lone Star Neurology
Recruiting
Frisco,Texas,75035,United States
Ramin Ansari
SFM Clinical Research LLC
Recruiting
Boca Raton,Florida,33487,United States
Marc Feinberg
Metrolina Neurological Associates PA .
Recruiting
Indian Land,South Carolina,29707,United States
Howard Mandell
Vladimir Royter MD APMC
Recruiting
Hanford,California,93230,United States
Vladimir Royter
Hope Neurology
Recruiting
Knoxville,Tennessee,37922,United States
Sibyl Wray
Piedmont HealthCare
Recruiting
Charlotte,North Carolina,28210,United States
Matthew Carraro
University of Washington MS Clinic
Recruiting
Seattle,Washington,98133,United States
Gloria Von Geldern
Gables Neurology
Recruiting
Miami,Florida,33133,United States
Andrew Lerman
Baptist Physicians Lexington .
Recruiting
Nicholasville,Kentucky,40356,United States
James Winkley
University of Kansas Medical Center CFTY720D2399E1
Recruiting
Kansas City,Kansas,66160-7330,United States
Sharon Lynch
CU Anschutz Med Campus
Recruiting
Aurora,Colorado,80045,United States
Enrique Alvarez
Advent Health Orlando
Recruiting
Orlando,Florida,32803,United States
Ryan Mizell
Comprehensive Neurology
Recruiting
Frederick,Maryland,21702,United States
Shahid Rafiq
Memorial Healthcare .
Recruiting
Owosso,Michigan,48867,United States
Jordan Brooks
Robert Joseph Pace
True North Neurology .
Recruiting
Port Jefferson Station,New York,11776,United States
Maryana Liedke
South Shore Neurologic Associates CFTY720D2403
Recruiting
Patchogue,New York,11772,United States
Joanna Weller
Mark Gudesblatt
Lonestar Neurology of San Antonio
Recruiting
San Antonio,Texas,78258,United States
Ann Bass
Neurology Associates, PA
Recruiting
Maitland,Florida,32751,United States
William David Honeycutt
Premier Neurology
Recruiting
Greenville,South Carolina,29650,United States
Mary Denise Hughes
Humanity Clinical Research .
Recruiting
Pembroke Pines,Florida,33024,United States
Linda S Dolin
Georgetown University Hospital Research
Recruiting
Washington,District of Columbia,20007,United States
Faria Amjad
Nova Clinical Research LLC .
Recruiting
Bradenton,Florida,34209,United States
Sanjay Yathiraj
Vero Beach Neurology .
Recruiting
Vero Beach,Florida,32960,United States
Stuart Shafer
Brain and Spine Institute
Recruiting
Port Orange,Florida,32127,United States
Timothy Wierzbicki
University of Miami Miller School of Medicine .
Recruiting
Miami,Florida,33136,United States
Silvia R Delgado
Elligo Health Research
Recruiting
Crab Orchard,West Virginia,25827,United States
Barry Vaught
Aqualane Clinical Research .
Recruiting
Naples,Florida,34102,United States
Matthew J Baker
Tufts Medical Center .
Recruiting
Boston,Massachusetts,02111,United States
Kristen Babinski
Conquest Research
Recruiting
Winter Park,Florida,32789,United States
Rekha Gandhi
Memorial Hospital .
Recruiting
Hollywood,Florida,33021,United States
Buse Sengul
Worldwide Contacts
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