What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta, glatiramer acetate, dimethyl fumarate, and monoclonal antibodies like alemtuzumab. Interferon beta can cause flu-like symptoms and injection site reactions. Glatiramer acetate may lead to local injection site reactions and transient systemic reactions. Dimethyl fumarate is associated with gastrointestinal issues and flushing. Alemtuzumab can cause infusion reactions, increased risk of infections, and autoimmune disorders. For Bruton's Tyrosine Kinase inhibitors like Evobrutinib, specific side effects are not detailed, but they generally include risks of infections and potential liver enzyme elevations.

What prior FDA approvals exist?

Evobrutinib is a Bruton's Tyrosine Kinase (BTK) inhibitor currently being studied for the treatment of Relapsing Multiple Sclerosis (RMS). While BTK inhibitors are a newer class of drugs in MS treatment, other FDA-approved therapies for MS include interferon beta-1a, glatiramer acetate, and more recently, monoclonal antibodies like alemtuzumab and ocrelizumab. These treatments aim to modulate the immune system to reduce relapse rates and slow disease progression. Alemtuzumab, for instance, is reserved for patients with highly active MS who have not responded to other disease-modifying therapies.

What other types of research exist?

Promising novel alternatives to Evobrutinib for Multiple Sclerosis patients include: 1) Siponimod, a selective sphingosine 1-phosphate receptor modulator, which has shown efficacy in secondary progressive MS. 2) Ozanimod, another sphingosine 1-phosphate receptor modulator, approved for relapsing forms of MS. 3) Ofatumumab, a fully human anti-CD20 monoclonal antibody, approved for relapsing MS. 4) Ponesimod, a selective sphingosine 1-phosphate receptor 1 modulator, approved for relapsing forms of MS. These alternatives offer different mechanisms of action and have demonstrated positive outcomes in clinical studies.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Evobrutinib for Relapsing Multiple Sclerosis

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

Bruton's Tyrosine Kinase (BTK) inhibitors, such as Evobrutinib, target B cells that play a significant role in the autoimmune response in Multiple Sclerosis (MS). By inhibiting BTK, these treatments reduce the activity of B cells, thereby decreasing inflammation and immune-mediated damage to the nervous system. Other common MS treatments include beta interferons, which modulate the immune response to reduce inflammation, and glatiramer acetate, which acts as a myelin protein mimic to divert the immune system's attack away from actual myelin. These mechanisms are vital for reducing relapses, slowing disease progression, and improving the overall quality of life for MS patients.

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

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 156 weeks

Awards & highlights

Pivotal Trial

Summary

This trial compares a new medication, Evobrutinib, with an existing medication, Teriflunomide (Aubagio®). Teriflunomide (Aubagio®) is derived from leflunomide, a well-known treatment for autoimmune conditions. The trial focuses on people with relapsing multiple sclerosis, a condition where symptoms come and go. Both treatments aim to reduce the immune system's attacks on the nervous system to help manage symptoms and reduce flare-ups.

Who is the study for?

This trial is for adults with Relapsing Multiple Sclerosis (RMS) who've had at least one relapse in the past two years or a specific type of brain lesion within six months. They should have an EDSS score between 0 to 5.5, and if their score is <=2, they must be diagnosed within the last ten years. Women must not be pregnant or breastfeeding and use contraception; men also need to use contraception.

What is being tested?

The study compares Evobrutinib taken twice daily against Teriflunomide taken once daily for RMS safety and effectiveness. Participants will go through a double-blind period where neither they nor the researchers know who's getting which drug, followed by an option for open-label Evobrutinib treatment.

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions associated with oral MS medications such as liver issues, hair thinning, diarrhea, nausea, and potential risk of infections due to immune system effects.

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

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I have been diagnosed with Progressive MS without recent relapses.

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 that play a significant role in the autoimmune response in Multiple Sclerosis (MS). By inhibiting BTK, these treatments reduce the activity of B cells, thereby decreasing inflammation and immune-mediated damage to the nervous system. Other common MS treatments include beta interferons, which modulate the immune response to reduce inflammation, and glatiramer acetate, which acts as a myelin protein mimic to divert the immune system's attack away from actual myelin. These mechanisms are vital for reducing relapses, slowing disease progression, and improving the overall quality of life for MS patients.