A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety.
- Conditions
- Relapsing Multiple Sclerosis (RMS)10028037
- Registration Number
- NL-OMON54887
- Lead Sponsor
- Merck Healthcare KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
- 18 years to 55 years female and male participants
- 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
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>ARR based on qualified relapses at Week 96 in participants with RMS</p><br>
- Secondary Outcome Measures
Name Time Method