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Bruton's Tyrosine Kinase (BTK) Inhibitor

Evobrutinib vs Teriflunomide for Multiple Sclerosis

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

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 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

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

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.

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Industry Sponsor
82 Previous Clinical Trials
21,313 Total Patients Enrolled
13 Trials studying Multiple Sclerosis
7,918 Patients Enrolled for Multiple Sclerosis
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyLead Sponsor
56 Previous Clinical Trials
6,308 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
2,435 Patients Enrolled for Multiple Sclerosis
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
297 Previous Clinical Trials
59,747 Total Patients Enrolled
42 Trials studying Multiple Sclerosis
15,707 Patients Enrolled for Multiple Sclerosis

Media Library

Evobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04338022 — Phase 3
Multiple Sclerosis Research Study Groups: Teriflunomide + Evobrutinib matched Placebo: DB Period, Evobrutinib + Teriflunomide matched Placebo: DB Period
Multiple Sclerosis Clinical Trial 2023: Evobrutinib Highlights & Side Effects. Trial Name: NCT04338022 — Phase 3
Evobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04338022 — Phase 3
~214 spots leftby Oct 2025