Study of Evobrutinib in Participants With 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: 1.0
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
      Relapsing Multiple Sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants 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 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.