What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include glatiramer acetate, dimethyl fumarate, and teriflunomide. Glatiramer acetate can cause local injection site reactions such as pain and redness. Dimethyl fumarate is associated with gastrointestinal issues, flushing, and a potential decrease in lymphocyte counts. Teriflunomide may lead to liver toxicity, gastrointestinal disturbances, and hair thinning. These side effects are important considerations for patients and healthcare providers when selecting an appropriate MS treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS), including disease-modifying therapies (DMTs) that target various pathways involved in the disease. While Evobrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, is currently under investigation, other BTK inhibitors like ibrutinib have been explored for different conditions. For MS, approved treatments include interferon beta drugs, glatiramer acetate, and newer oral medications such as fingolimod, dimethyl fumarate, and teriflunomide. Monoclonal antibodies like natalizumab, ocrelizumab, and alemtuzumab have also been approved, offering various mechanisms of action to manage the disease.

What other types of research exist?

Promising novel alternatives to Evobrutinib for Multiple Sclerosis patients include: 1. Ocrelizumab: A monoclonal antibody targeting CD20-positive B cells, effective in both relapsing and primary progressive MS. 2. Siponimod: A selective sphingosine-1-phosphate receptor modulator, effective in secondary progressive MS. 3. Cladribine: An oral immunosuppressive drug, effective in relapsing forms of MS. 4. Ofatumumab: A fully human anti-CD20 monoclonal antibody, effective in relapsing MS. These alternatives offer different mechanisms of action and have shown efficacy in clinical trials.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Evobrutinib vs Teriflunomide for Multiple Sclerosis

Q: What is the mechanism of action of this treatment?

Bruton's Tyrosine Kinase (BTK) inhibitors, such as Evobrutinib, target B cells involved in the autoimmune response in Multiple Sclerosis (MS), reducing their activity and thereby decreasing inflammation and disease progression. Other common treatments include interferon beta, which modulates the immune response to reduce inflammation, and monoclonal antibodies like alemtuzumab, which deplete immune cells attacking myelin. Understanding these mechanisms helps MS patients and their doctors choose the most appropriate therapy based on disease activity and progression.

Phase 3

Waitlist Available

Research Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)

Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization

Must not have

Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b). Participants with secondary progressive MS without evidence of relapse

Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening and Baseline (Day 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 156 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is comparing two pills, evobrutinib and Teriflunomide, for people with relapsing multiple sclerosis. The goal is to see which one works better at calming down the immune system to protect the nerves. Teriflunomide is a treatment approved for relapsing multiple sclerosis and has been shown to reduce relapse rates and slow disease progression.

Who is the study for?

This trial is for people with Relapsing Multiple Sclerosis (RMS) who have had at least one relapse in the past two years or a specific type of lesion within six months. Participants should have an EDSS score between 0 and 5.5, be stable neurologically for over a month before starting, and agree to use contraception due to long-term effects of Teriflunomide.

What is being tested?

The study compares the effectiveness and safety of Evobrutinib taken twice daily against Teriflunomide taken once daily. After completing initial phases, participants may continue with Evobrutinib in an open-label extension for up to 96 weeks.

What are the potential side effects?

While not specified here, common side effects from drugs like Evobrutinib could include digestive issues, liver enzyme changes, high blood pressure, headaches or infections. Side effects from Teriflunomide often include hair thinning, diarrhea, nausea and potential liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with RMS according to the 2017 McDonald criteria.

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I have had at least one relapse in the past 2 years or a recent MRI showing active disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Progressive MS without recent relapses.

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My disease has lasted more than 10 years and I have mild disability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 156 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 156 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 156 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DBE Period: ARR

DBTP: Annualized Relapse Rate (ARR)

Secondary study objectives

DBE Period: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

DBE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings

DBTP: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Evobrutinib + Teriflunomide matched Placebo: DB PeriodExperimental Treatment2 Interventions

Group II: Teriflunomide + Evobrutinib matched Placebo: DB PeriodActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Evobrutinib

2019

Completed Phase 1

~130

0 / 4Eligibility criteria met

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

Bruton's Tyrosine Kinase (BTK) inhibitors, such as Evobrutinib, target B cells involved in the autoimmune response in Multiple Sclerosis (MS), reducing their activity and thereby decreasing inflammation and disease progression. Other common treatments include interferon beta, which modulates the immune response to reduce inflammation, and monoclonal antibodies like alemtuzumab, which deplete immune cells attacking myelin. Understanding these mechanisms helps MS patients and their doctors choose the most appropriate therapy based on disease activity and progression.