Study of Evobrutinib in Participants With RMS

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Relapsing-remitting Multiple Sclerosis

In brief

The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with Relapsing Multiple Sclerosis (RMS).

Key facts

Study ID

NCT04032171

Run by

EMD Serono Research & Development Institute, Inc.

People needed

1

Starts

2019-09-10

Expected to finish

2020-05-20

Last updated by the study team

2021-08-05

Who can join

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

You may qualify if…

• Participants 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 EDSS score of 0 to 5.5 at Baseline. Participants with an EDSS score <= 2 at screening 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 and 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.
• 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.
• 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

• Please Contact U.S. Medical Information — Rockland, Massachusetts, United States
• Please Contact the Communication Center — Darmstadt, Germany

Full record on ClinicalTrials.gov

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