Active, not recruiting
Phase 3
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)
Condition(s) studied
Relapsing Multiple Sclerosis
Investigational drug(s) / intervention(s)
RemibrutinibTeriflunomide
Remibrutinib: tablet taken orally
Teriflunomide: capsule taken orally
Study summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
Eligibility
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.
Primary outcome measure(s)
- Annualized relapse rate (ARR) of confirmed relapses [Core Part] — From Baseline, up to 30 months
ARR is the average number of confirmed MS relapses in a year
Trial sites (223)
| Facility | City | Region | Status |
| Ctr for Neurology and Spine |
Phoenix |
Arizona |
|
| Vladimir Royter MD APMC |
Hanford |
California |
|
| VA Greater LA Healthcare System |
Los Angeles |
California |
|
| Regina Berkovich MD PhD Inc |
West Hollywood |
California |
|
| CU Anschutz Med Campus |
Aurora |
Colorado |
|
| Colorado Neurological Research PC |
Denver |
Colorado |
|
| New England Institute for Clinical Research |
Stamford |
Connecticut |
|
| Georgetown University Hospital Research |
Washington D.C. |
District of Columbia |
|
| Georgetown University Hospital |
Washington D.C. |
District of Columbia |
|
| Nova Clinical Research LLC |
Bradenton |
Florida |
|
| University of Florida |
Gainesville |
Florida |
|
| Memorial Healthcare System |
Hollywood |
Florida |
|
| Neurology Associates PA |
Maitland |
Florida |
|
| Gables Neurology |
Miami |
Florida |
|
| UM Department Of Neurology |
Miami |
Florida |
|
| Aqualane Clinical Research |
Naples |
Florida |
|
| Advent Health Orlando |
Orlando |
Florida |
|
| Humanity Clinical Research |
Pembroke Pines |
Florida |
|
| Emerald Coast Neurology |
Pensacola |
Florida |
|
| Brain and Spine Institute |
Port Orange |
Florida |
|
| Vero Beach Neurology |
Vero Beach |
Florida |
|
| Conquest Research |
Winter Park |
Florida |
|
| Methodist Neuroscience Institute |
Merrillville |
Indiana |
|
| University of Kansas Hospital |
Kansas City |
Kansas |
|
| Baptist Physicians Lexington |
Nicholasville |
Kentucky |
|
| Ochsner Clinic Foundation |
New Orleans |
Louisiana |
|
| Clinre Comprehensive Neurology |
Frederick |
Maryland |
|
| Tufts Medical Center |
Boston |
Massachusetts |
|
| Kansas City VA Medical Center |
Kansas City |
Missouri |
|
| South Shore Neurologic Associates |
Patchogue |
New York |
|
| University Of NC At Chapel Hill |
Chapel Hill |
North Carolina |
|
| Piedmont HealthCare |
Charlotte |
North Carolina |
|
| The Boster Ctr for MS |
Columbus |
Ohio |
|
| Neurology Diagnostics Inc |
Dayton |
Ohio |
|
| Penn State Hershey Medical Center |
Hershey |
Pennsylvania |
|
| Premier Neurology |
Greenville |
South Carolina |
|
| Metrolina Neurological Associates PA |
Old Point Station |
South Carolina |
|
| Sibyl Wray MD Neurology PC |
Knoxville |
Tennessee |
|
| Neurology Consultants Of Dallas PA |
Dallas |
Texas |
|
| Med Research Inc |
El Paso |
Texas |
|
+ 183 more sites — see the full list on the official registry below.