Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

  • STATUS
    Recruiting
  • End date
    Jul 10, 2026
  • participants needed
    930
  • sponsor
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Updated on 2 September 2021
teriflunomide
aubagio
evobrutinib

Summary

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS).

Details
Condition Relapsing Multiple Sclerosis
Treatment Evobrutinib, Teriflunomide, Placebo (match to Teriflunomide), Placebo (match to Evobrutinib)
Clinical Study IdentifierNCT04338061
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years
Participants are neurologically stable for >= 30 days prior to both screening and baseline
Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
Participants have given written informed consent prior to any study-related procedure
Other protocol defined inclusion criteria could apply

Exclusion Criteria

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
Immunologic disorder other than MS, or any other condition requiring oral
intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy
with the exception of well-controlled Type 2 diabetes mellitus or well
controlled thyroid disease
Other protocol defined exclusion criteria could apply
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