Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 3

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: Evobrutinib; Drug: Avonex® matched Placebo; Drug: Evobrutinib matched Placebo; Drug: Avonex®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04032158

2018-004701-11 (EudraCT Number)

MS200527_0073

Details and patient eligibility

About

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 RMS.

Enrollment: 3 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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 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.
• Other protocol defined exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups

Evobrutinib + Avonex® matched Placebo

Experimental group

Description:

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.

Treatment:

Drug: Avonex® matched Placebo

Drug: Evobrutinib

Avonex® + Evobrutinib matched Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Evobrutinib matched Placebo

Drug: Avonex®