Viewing Study NCT04032158


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Ignite Modification Date: 2026-02-25 @ 6:56 PM
Study NCT ID: NCT04032158
Status: TERMINATED
Last Update Posted: 2021-08-05
First Post: 2019-07-23
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
Sponsor: EMD Serono Research & Development Institute, Inc.
Organization:

Study Overview

Official Title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety
Status: TERMINATED
Status Verified Date: 2021-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0073. Consequently, this trial terminated early.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
2018-004701-11 EUDRACT_NUMBER None View