Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
The study is 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.
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.