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Bruton's Tyrosine Kinase (BTK) Inhibitor

Remibrutinib vs Teriflunomide for Multiple Sclerosis (REMODEL-2 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)
Neurologically stable within 1 month
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 use of moderate or strong CYP3A4 inducers within two weeks prior to randomization
Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 months
Awards & highlights

Summary

This trial compares the effectiveness and safety of two different drugs for people with relapsing multiple sclerosis.

Who is the study for?
Adults aged 18-55 with Relapsing Multiple Sclerosis (RMS) who've had at least one relapse in the past year or a new lesion. They must be neurologically stable, not have primary progressive MS, no severe CNS diseases other than MS, and no history of certain cancers or infections like PML. Women must use effective contraception; men agree to use condoms.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of Remibrutinib compared to Teriflunomide in treating RMS. Participants will receive either drug and their health outcomes will be monitored to see which treatment works better for controlling the disease.See study design
What are the potential side effects?
Potential side effects may include liver problems, infection risks due to immune system effects, digestive issues, allergic reactions to medication components, blood disorders such as low platelet counts or anemia, and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disability level allows me to walk without aid or rest for 200 meters.
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My neurological condition has been stable for the last month.
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My condition meets the 2017 criteria for RMS diagnosis.
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My condition has worsened at least once in the past year or I have had an active lesion recently.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had Progressive Multifocal Leukoencephalopathy or symptoms like it.
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I have a significant brain or nerve condition other than multiple sclerosis.
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I have had cancer in the past, but it was either skin cancer removed completely or cervical cancer that did not spread.
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I have severe kidney problems or high creatinine levels.
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I have a history of or am currently being treated for liver disease.
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I have been diagnosed with primary progressive multiple sclerosis.
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I do not have any serious ongoing infections.
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I have had my spleen removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
Secondary outcome measures
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 more

Trial 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 primarily aim to modulate the immune system to reduce inflammation and prevent further damage to the nervous system. Common treatments include interferon beta, which reduces inflammatory cell migration across the blood-brain barrier, and glatiramer acetate, which shifts the immune response from a pro-inflammatory to an anti-inflammatory state. Oral therapies like dimethyl fumarate and teriflunomide inhibit immune cell activation and proliferation. Bruton's Tyrosine Kinase (BTK) inhibitors, such as Remibrutinib, target B-cell and myeloid cell signaling pathways, potentially reducing the activity of these immune cells in MS. These mechanisms are crucial for MS patients as they help manage relapses, slow disease progression, and improve quality of life by minimizing neurological damage.
Therapeutic management of severe relapses in multiple sclerosis.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,191 Total Patients Enrolled
102 Trials studying Multiple Sclerosis
51,357 Patients Enrolled for Multiple Sclerosis

Media Library

Remibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05156281 — Phase 3
Multiple Sclerosis Research Study Groups: Remibrutinib - Core, Teriflunomide - Core, Remibrutinib - Extension, Remibrutinib - Extension (on teriflunomide in Core)
Multiple Sclerosis Clinical Trial 2023: Remibrutinib Highlights & Side Effects. Trial Name: NCT05156281 — Phase 3
Remibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156281 — Phase 3
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