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Bruton's Tyrosine Kinase (BTK) Inhibitor

Evobrutinib for Relapsing Multiple Sclerosis

Q: What other scientific research studies have included Evobrutinib?

Evobrutinib was first trialed in 2014 at site 056001. 38 studies have completed since then, with 14 more currently recruiting patients. A large number of these latter studies are based out of Port Charlotte, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a>.

Q: Which group of individuals would be best for this experiment?

This clinical trial is testing an investigational medication for people with <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>. To be eligible, patients must: Be between the ages of 18 and 55, have been diagnosed with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis that includes relapses, have had one or more documented relapses in the last two years OR have at least one gadolinium-enhancing T1 lesion within 6 months of screening, have an Expanded Disability Status Scale score of 0 to 5.5 at screening and baseline, if their EDSS score is &#x3C;= 2 at screening and baseline, their disease duration can't be more than

Q: Does Evobrutinib carry a high risk for developing serious side effects?

Evobrutinib has received a score of 3 for safety. This is due to the fact that it is in Phase 3 trials, indicating that while there is some data supporting efficacy, multiple rounds of data have been collected affirming its safety.

Q: Does this study only accept participants who are under 30 years old?

This trial is only open to patients that fall in between the ages of 18 to 55, as specified in the inclusion criteria.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 156

Awards & highlights

Study Summary

This trial will compare the effectiveness of two drugs for treating relapsing multiple sclerosis.

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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with RMS following the 2017 McDonald criteria.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 156

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 156

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DBE Period: ARR

DBTP: Annualized Relapse Rate (ARR)

OLE Period: Number of Participants with Adverse Events and Serious Adverse Events (SAE)s

Secondary outcome measures

DBE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels

DBE Period: Change From Baseline in Immunoglobulin (Ig) Levels

DBE Period: Change From Baseline in PROMIS MS Fatigue Short Form Score

+29 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Industry Sponsor

76 Previous Clinical Trials

29,736 Total Patients Enrolled

13 Trials studying Multiple Sclerosis

16,142 Patients Enrolled for Multiple Sclerosis

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyLead Sponsor

51 Previous Clinical Trials

5,737 Total Patients Enrolled

7 Trials studying Multiple Sclerosis

2,439 Patients Enrolled for Multiple Sclerosis

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

288 Previous Clinical Trials

67,851 Total Patients Enrolled

42 Trials studying Multiple Sclerosis

23,935 Patients Enrolled for Multiple Sclerosis

Media Library

Evobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04338061 — 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: NCT04338061 — Phase 3

Evobrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04338061 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific research studies have included Evobrutinib?

"Evobrutinib was first trialed in 2014 at site 056001. 38 studies have completed since then, with 14 more currently recruiting patients. A large number of these latter studies are based out of Port Charlotte, Florida."

Answered by AI

Which group of individuals would be best for this experiment?

"This clinical trial is testing an investigational medication for people with multiple sclerosis. To be eligible, patients must: Be between the ages of 18 and 55, have been diagnosed with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis that includes relapses, have had one or more documented relapses in the last two years OR have at least one gadolinium-enhancing T1 lesion within 6 months of screening, have an Expanded Disability Status Scale score of 0 to 5.5 at screening and baseline, if their EDSS score is <= 2 at screening and baseline, their disease duration can't be more than"

Answered by AI

Does Evobrutinib carry a high risk for developing serious side effects?

"Evobrutinib has received a score of 3 for safety. This is due to the fact that it is in Phase 3 trials, indicating that while there is some data supporting efficacy, multiple rounds of data have been collected affirming its safety."

Answered by AI