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Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

TerminatedPhase 3

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Conditions: Relapsing Multiple Sclerosis

Interventions: Teriflunomide, Evobrutinib

Countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (279)

Mobile, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Long Beach, California, United States
Pasadena, California, United States
San Diego, California, United States
Stamford, Connecticut, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Elk Grove Village, Illinois, United States
Northbrook, Illinois, United States
Peoria, Illinois, United States
Rolling Meadows, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Foxborough, Massachusetts, United States
Lawrence, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Farmington Hills, Michigan, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
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