Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Recruiting · NCT06846281 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
OcrelizumabRemibrutinib oral treatment
What this trial is about
The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).
Who can take part
Age range
40 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female aged 40 to 70 years (inclusive)
- Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
- Treated with ocrelizumab according to routine clinical practice and at standard dose
- Neurologically stable within 30 days
- Suitable to be switched to remibrutinib based on physician judgement or patient preference
- Key
Exclusion criteria
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria
- History of clinically significant Central Nervous System disease or neurological disorders
- History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent
- Active clinically significant systemic bacterial, viral, parasitic or fungal infections
- Active, chronic disease of the immune system other than MS
- Severe cardiac disease or significant findings on the ECG
- Participant who is unable to undergo MRI scans
- History of life-threatening infusion or injection reaction related to ocrelizumab
- Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening)
- ther inclusion and exclusion criteria may apply
Where it is running
60 locations listed across 23 US states.
- Perseverance Research Center - Scottsdale, Arizona, United States
- University of California Irvine - Irvine, California, United States
- Medstar Washington Hospital Center - Washington D.C., District of Columbia, United States
- Neurology of Central FL Res Ctr - Altamonte Springs, Florida, United States
- University of Florida - Gainesville, Florida, United States
- Memorial Healthcare System - Hollywood, Florida, United States
- Neurology Associates PA - Maitland, Florida, United States
- Elite Clinical Research - Miami, Florida, United States
- Aqualane Clinical Research - Naples, Florida, United States
- Advent Health Orlando - Orlando, Florida, United States
- Orlando Health Clinical Trials - Orlando, Florida, United States
- Tallahassee Neurological Clinic - Tallahassee, Florida, United States
- University Of South Florida - Tampa, Florida, United States
- Vero Beach Neurology - Vero Beach, Florida, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- University of Kansas Hospital - Kansas City, Kansas, United States
- MedStar Montgomery Medical Center - Olney, Maryland, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Lahey Hospital and Medical Center - Burlington, Massachusetts, United States
- Neurology Center of New England PC - Foxborough, Massachusetts, United States
- Michigan Institute of Neurological - Farmington Hills, Michigan, United States
- Memorial HC Ins for Neuroscience - Owosso, Michigan, United States
- WA Uni School Of Med - St Louis, Missouri, United States
- Cleveland Clinic Foundation - Las Vegas, Nevada, United States
- Holy Name Medical Center - Teaneck, New Jersey, United States
- University of New Mexico - Albuquerque, New Mexico, United States
- SUNY Buffalo The Jacobs Neuro Inst - Buffalo, New York, United States
- Velocity Clinical Research - Raleigh, North Carolina, United States
- Sanford Health - Fargo, North Dakota, United States
- Premier Health - Centerville, Ohio, United States
- Univ of Cincinnati Medical Center - Cincinnati, Ohio, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- Ohio Health Research Institute - Columbus, Ohio, United States
- Providence Neurological Services West - Portland, Oregon, United States
- Premier Neurology - Greenville, South Carolina, United States
- Sibyl Wray MD Neurology PC - Knoxville, Tennessee, United States
- Austin Regional Clinic - Austin, Texas, United States
- Univ of Texas Southwest Med Center - Dallas, Texas, United States
- John Peter Smith Hospital - Fort Worth, Texas, United States
- Saturn Research Solutions LLC - Plano, Texas, United States
- Virginia Commonwealth University - Richmond, Virginia, United States
- Center for Neurological Disorders G - Greenfield, Wisconsin, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Novartis Investigative Site - Aarhus N, Denmark
- Novartis Investigative Site - Barcelona, Spain
- Novartis Investigative Site - Berlin, Germany
- Novartis Investigative Site - Bern, Switzerland
- Novartis Investigative Site - Bochum, Germany
- Novartis Investigative Site - Bordeaux, France
- Novartis Investigative Site - Braga, Portugal
- Novartis Investigative Site - Brno, Czechia
- Novartis Investigative Site - Brno, Czechia
- Novartis Investigative Site - Bruges, Belgium
- Novartis Investigative Site - Buenos Aires, Argentina
- Novartis Investigative Site - Caba, Argentina
- Novartis Investigative Site - Chaïdári, Greece
- Novartis Investigative Site - Clermont-Ferrand, France
- Novartis Investigative Site - Coimbra, Portugal
- Novartis Investigative Site - Córdoba, Spain
Showing 60 of 129 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →