daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with
Relapsing Multiple Sclerosis (RMS).
– 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
– 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.
– 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.
- Research Site 751, Hanford, California, United States, 93230