Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Evobrutinib; Avonex®; Avonex® matched Placebo; Evobrutinib matched Placebo
Intervention description: Participants received evobrutinib twice daily (BID).; Participants received avonex® IM injection once a week.; Participants received IM injection of placebo matched to Avonex® once a week.; Participants received placebo matched to evobrutinib twice a day.
Intervention MeSH terms: Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Evobrutinib; Avonex®; Interferon-beta 1a; Relapsing Multiple Sclerosis

Summary:

      The study was to evaluate the efficacy and safety of evobrutinib administered orally twice
      daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with
      RMS.
    

Eligibility criteria:

        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 Baseline.
        Participants with an EDSS score <= 2 at Screening 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 and 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 - 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.