Your session is about to expire
← Back to Search
Bruton's Tyrosine Kinase (BTK) Inhibitor
Remibrutinib vs Teriflunomide for Multiple Sclerosis (REMODEL-1 Trial)
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
EDSS score of 0 to 5.5 (inclusive)
18 to 55 years of age
Must not have
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 strong CYP3A4 inducers within two weeks prior to randomization
Participants who have had a splenectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 months
Awards & highlights
Summary
This trial compares remibrutinib and teriflunomide in patients with relapsing multiple sclerosis. It aims to find out which medication is more effective and safer. Both drugs work by controlling the immune system to reduce relapses. Teriflunomide is an approved treatment for adults with this condition.
Who is the study for?
Adults aged 18-55 with Relapsing Multiple Sclerosis (RMS) as per the McDonald criteria, an EDSS score of 0 to 5.5, and a recent history of relapses or active lesions are eligible. Exclusions include those with certain cancers, mental health risks, other immune diseases besides MS, substance abuse issues, significant organ disorders or infections, severe allergies to study drugs or components, pregnant/nursing women, and those not using effective contraception.
What is being tested?
The trial is testing the effectiveness and safety of Remibrutinib compared to Teriflunomide in treating RMS. Participants will be randomly assigned to receive either Remibrutinib or Teriflunomide while their health outcomes are monitored.
What are the potential side effects?
Potential side effects for both medications may include liver problems, hair thinning or loss (Teriflunomide), increased risk of infection due to immune system effects (Remibrutinib), gastrointestinal disturbances like nausea or diarrhea, headaches and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disability level allows me to walk without aid or rest for at least 200 meters.
Select...
I am between 18 and 55 years old.
Select...
My condition meets the 2017 criteria for RMS diagnosis.
Select...
My neurological condition has been stable for the last month.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had my spleen removed.
Select...
My disease has lasted over 10 years and I have little to no disability.
Select...
I have severe kidney problems or high creatinine levels.
Select...
I have a significant brain or nerve condition other than multiple sclerosis.
Select...
I have had Progressive Multifocal Leukoencephalopathy or symptoms like it.
Select...
I have been diagnosed with primary progressive multiple sclerosis.
Select...
I have no history or current treatment for serious liver diseases.
Select...
I do not have any serious ongoing infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 30 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
Secondary study objectives
Annualized rate of new or enlarging T2 lesion [Core Part]
Annualized rate of new or enlarging T2 lesion [Extension Part]
Annualized relapse rate (ARR) of confirmed relapses [Extension Part]
+21 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Remibrutinib - Extension (on teriflunomide in Core)Experimental Treatment1 Intervention
Participants on teriflunomide in Core will switch to remibrutinib tablet
Group II: Remibrutinib - ExtensionExperimental Treatment1 Intervention
Participants on remibrutinib in Core will continue on remibrutinib tablet
Group III: Remibrutinib - CoreExperimental Treatment1 Intervention
Remibrutinib tablet and matching placebo of teriflunomide capsule
Group IV: Teriflunomide - CoreActive Control1 Intervention
Teriflunomide capsule and matching placebo remibrutinib tablet
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Sclerosis (MS) treatments generally aim to modulate the immune system to reduce inflammation and prevent immune cells from attacking the myelin sheath. Common treatments include interferon beta, which reduces inflammatory cytokines; glatiramer acetate, which acts as a myelin decoy; and monoclonal antibodies like natalizumab, which block immune cell migration into the central nervous system.
Bruton's Tyrosine Kinase (BTK) inhibitors, such as Remibrutinib, specifically target B cells and other immune cells by inhibiting BTK, a key enzyme in the signaling pathways that lead to their activation and proliferation. This targeted approach can potentially reduce the autoimmune response more precisely, leading to fewer side effects and better management of MS symptoms.
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,896 Previous Clinical Trials
4,200,904 Total Patients Enrolled
105 Trials studying Multiple Sclerosis
51,038 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at risk for hepatitis reactivation.I have had my spleen removed.My condition has worsened at least once in the past year or I have had a new active lesion.My disease has lasted over 10 years and I have little to no disability.I have severe kidney problems or high creatinine levels.My disability level allows me to walk without aid or rest for at least 200 meters.I have a chronic immune system disease other than MS, but it's under control.I have a significant brain or nerve condition other than multiple sclerosis.I have had Progressive Multifocal Leukoencephalopathy or symptoms like it.I have been diagnosed with primary progressive multiple sclerosis.I do not have any major health issues that could affect the study.I have no history or current treatment for serious liver diseases.I am between 18 and 55 years old.My condition meets the 2017 criteria for RMS diagnosis.I do not have any serious ongoing infections.My neurological condition has been stable for the last month.I have a condition like asthma or IBD that often requires steroids.I have had cancer before, but it was completely removed or was only skin or cervical cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Remibrutinib - Core
- Group 2: Teriflunomide - Core
- Group 3: Remibrutinib - Extension
- Group 4: Remibrutinib - Extension (on teriflunomide in Core)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger