Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

Last updated: March 13, 2025
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Terminated

Phase

3

Condition

Multiple Sclerosis

Neurologic Disorders

Scar Tissue

Treatment

Teriflunomide

Placebo (match to Teriflunomide)

Evobrutinib

Clinical Study ID

NCT04338061
MS200527_0082
2019-004980-36
  • Ages 18-55
  • All Genders

Study 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). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

Eligibility Criteria

Inclusion

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 beforeScreening with either: a. one relapse which occurred within the last year prior torandomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesionwithin 6 months prior to randomization

  • Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 atScreening and Baseline (Day 1). Participants with an EDSS score less than or equalto [<=] 2 at Screening and Baseline (Day 1) are only eligible for participation iftheir disease duration (time since onset of symptoms) is no more than 10 years

  • Participants are neurologically stable for >= 30 days prior to both screening andbaseline (Day 1)

  • Female participants must be neither pregnant nor breast-feeding or must lackchild-bearing potential (as defined by either: post-menopausal or surgicallysterile), or use an effective method of contraception for the duration of the studyand at least 2 years after study intervention due to the long elimination period forteriflunomide of 2 years, unless the participant undergoes an acceleratedelimination procedure

  • Male participants must refrain from donating sperm and/or abstain from intercoursewith women of child-bearing potential or use an effective method of contraceptionfor the duration of the study and at least 2 years after study intervention due tothe long elimination period for teriflunomide of 2 years, unless the participantundergoes an accelerated elimination procedure

  • Participants have given written informed consent prior to any study-relatedprocedure

  • Other protocol defined inclusion criteria could apply.

Exclusion

Exclusion Criteria:

  • Participants diagnosed with Progressive MS, in accordance with the 2017 RevisedMcDonald 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 atscreening and Baseline (Day 1)

  • Immunologic disorder other than MS, or any other condition requiring oral,intravenous (IV), intramuscular, or intra-articular corticosteroid therapy, with theexception of well-controlled Type 2 diabetes mellitus or well controlled thyroiddisease

  • Other protocol defined exclusion criteria could apply.

Study Design

Total Participants: 1166
Treatment Group(s): 4
Primary Treatment: Teriflunomide
Phase: 3
Study Start date:
July 02, 2020
Estimated Completion Date:
March 19, 2024

Connect with a study center

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    Passo Fundo,
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    Porto Alegre,
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    Bulgaria

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    Dayton, Ohio 45459
    United States

    Site Not Available

  • Research Site 748

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Research Site 703

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Research Site 721

    Norfolk, Virginia 23502
    United States

    Site Not Available

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