Study of Evobrutinib in Participants With RMS

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-05-20

Brief Summary

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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).

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Detailed Description

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Conditions

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Relapsing-remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Evobrutinib + Avonex® matched Placebo

Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.

Group Type EXPERIMENTAL

Evobrutinib

Intervention Type DRUG

Participants received evobrutinib twice daily (BID).

Avonex® matched Placebo

Intervention Type DRUG

Participants received IM injection of placebo matched to avonex® once a week.

Avonex® + Evobrutinib matched Placebo

Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.

Group Type ACTIVE_COMPARATOR

Avonex®

Intervention Type DRUG

Participants received avonex® IM injection once a week.

Evobrutinib matched Placebo

Intervention Type DRUG

Participants received placebo matched to evobrutinib twice a day.

Interventions

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Evobrutinib

Participants received evobrutinib twice daily (BID).

Intervention Type DRUG

Avonex®

Participants received avonex® IM injection once a week.

Intervention Type DRUG

Avonex® matched Placebo

Participants received IM injection of placebo matched to avonex® once a week.

Intervention Type DRUG

Evobrutinib matched Placebo

Participants received placebo matched to evobrutinib twice a day.

Intervention Type DRUG

Other Intervention Names

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M2951

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No