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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 156
Awards & highlights

Study Summary

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

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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with RMS according to 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 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

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: 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

Frequently Asked Questions

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

For this particular experiment, are octogenarians able to enroll?

"This clinical study is only open to patients that are between the ages of 18 and 55."

Answered by AI

What is the status of Evobrutinib's FDA approval?

"Evobrutinib's safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, so there is both some efficacy data as well as multiple rounds of safety data supporting this estimate."

Answered by AI

What other research exists on this topic?

"Work on Evobrutinib began in 2014 with a study sponsored by Genzyme, which is owned by Sanofi. This first Phase 3 trial had 166 participants. As of now, there are 14 active studies being conducted in 62 countries and 323 cities."

Answered by AI

Are participants being recruited for this research project currently?

"Unfortunately, this particular clinical trial is no longer admitting patients. The study was first posted on June 12th 2020 but the last update occurred on November 7th, 2022. However, if you are still exploring your options, there are 563 trials for multiple sclerosis and 14 for Evobrutinib that are actively recruiting participants right now."

Answered by AI

Could you tell me how many test subjects are involved in this experiment?

"This particular trial is not accepting patients at the moment. It was originally posted on June 12th, 2020 and updated for the last time on November 7th, 2022. There are 563 other trials concerning multiple sclerosis that are currently enrolling patients as well as 14 different clinical trials involving Evobrutinib which are actively recruiting participants."

Answered by AI

How many research facilities are coordinating this trial?

"There are 20 medical centres participating in this trial, including locations in Baltimore, Patchogue, and Phoenix."

Answered by AI

Is Evobrutinib a new or experimental drug?

"Evobrutinib was first trialled in 2014 at site 056001. As of now, 38 investigations have been completed while 14 are still ongoing. The majority of these studies taking place near Baltimore, Maryland."

Answered by AI

What type of patients would be the best match for this clinical trial?

"This study is looking for 898 participants that have been diagnosed with multiple sclerosis. The patients must be aged 18 to 55 and meet the following criteria: -Have had one or more documented relapses in the 2 years before screening OR have at least 1 gadolinium-enhancing T1 lesion within 6 months of randomization -An Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline -For those with an EDSS score <=2, disease duration (time since onset of symptoms) must be no more than 10 years"

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Research Site 101
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
2020. "Study of Evobrutinib in Participants With RMS (evolutionRMS 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04338022.
All > Amyotrophic Lateral Sclerosis
~233 spots leftby Apr 2025
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