Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

Stopped early · Phase 3

Conditions studied: Relapsing Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT04338061
Run by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
People needed: 1166
Starts: 2020-07-02
Expected to finish: 2024-03-19
Last updated by the study team: 2025-03-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 less than or equal to [<=] 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.

You may not qualify if…

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.

Where it is running

Research Site 741 — Scottsdale, Arizona, United States
Research Site 704 — Tucson, Arizona, United States
Research Site 751 — Hanford, California, United States
Research Site 737 — West Hollywood, California, United States
Research Site 759 — Colorado Springs, Colorado, United States
Research Site 725 — Fort Collins, Colorado, United States
Research Site 746 — Altamonte Springs, Florida, United States
Research Site 718 — Jacksonville, Florida, United States
Research Site 702 — Naples, Florida, United States
Research Site 740 — Orlando, Florida, United States
Research Site 726 — Port Charlotte, Florida, United States
Research Site 719 — Sarasota, Florida, United States
Research Site 743 — Tampa, Florida, United States
Research Site 707 — Tampa, Florida, United States
Research Site 732 — Vero Beach, Florida, United States
Research Site 705 — Weeki Wachee, Florida, United States
Research Site 753 — West Palm Beach, Florida, United States
Research Site 742 — Honolulu, Hawaii, United States
Research Site 715 — Evanston, Illinois, United States
Research Site 714 — Fort Wayne, Indiana, United States
Research Site 744 — Lafayette, Indiana, United States
Research Site 717 — Overland Park, Kansas, United States
Research Site 735 — Nicholasville, Kentucky, United States
Research Site 706 — Scarborough, Maine, United States
Research Site 752 — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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