study of evobrutinib in participants with rms (evolutionrms 1)

Conditions: Relapsing Multiple Sclerosis

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 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 (day 1) * 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 and baseline (day 1) * 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.

Keywords: evobrutinib teriflunomide aubagio® relapsing multiple sclerosis