Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 completing the Double-blind Treatment Period
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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Multiple Sclerosis
Enrollment Eligibility
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.