MS200527_0080 - Phase III Study of Evobrutinib in RMS
Research type
Research Study
Full title
A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety.
IRAS ID
283168
Contact name
Timothy Harrower
Contact email
Sponsor organisation
Merck Healthcare KGaA an affiliate of Merck KGaA, Darmstadt, Germany
Eudract number
2019-004972-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 11 months, 2 days
Research summary
Research Summary
The purpose of this study is to see how effectively evobrutinib can reduce relapses (patients who have attacks of new and old symptoms) compared to Aubagio® (teriflunomide). Evobrutinib is an investigational drug that is being evaluated for the treatment of patients with relapsing multiple sclerosis (RMS) and will be tested in a larger group of patients with RMS.
Approximately 930 people will participate in this study worldwide. The study will be conducted in approximately 300 medical centres in about 35 countries.Participation in this study will last for approximately 2 years and 4 months including up to 26 visits to the study centre.
The study is made up of 3 phases;
• Screening period (4 weeks) – this period may be extended but cannot exceed 8 weeks
• Treatment period (up to 2 years and 1 month)
• Follow-up period (4 weeks)Key Inclusion and Exclusion criteria:
Inclusion:
• Male and females aged 18 to 55 years
• Diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses)
• One or more documented relapses within the 2 years before ScreeningExclusion:
• Participants diagnosed with Progressive MS
• Disease duration > 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤ 2.0 at Screening and Baseline (Day 1)
• Immunologic disorder other than MS or any other condition requiring oral, intravenous, intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid diseaseEligible participants will be randomised 1:1 to treatment with evobrutinib 45 mg given twice daily in tablet form, or Aubagio® [teriflunomide]) 14 mg given once daily in tablet form. The treatment period will be a double blind (neither the participants nor the experimenters know who is receiving a particular treatment) and double dummy (a technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical) design.
Participants experiencing initial progression of disability between Week 72 and Week 96 will continue participating in the main study for up to 12 additional weeks, increasing participation to up to 108 weeks.
Participants who complete the 96-week (or up to Week 108) double blind, double dummy Treatment Period will be offered participation in the 148-week Open Label Extension (OLE) Period of the study.
Planned start date in UK: September 2020
Last participants in UK: September 2026Summary of Results
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.merckgroup.com%252Fen%252Ftrial-details%252F%253Fid%253DMS200527_0080%2FNBTI%2F1-67AQ%2FAQ%2Fc3a46e4a-c642-430c-bb84-216f29b00b54%2F2%2Fx14SdizocA&data=05%7C02%7Csheffield.rec%40hra.nhs.uk%7Cde418df198174c7a725b08dd631d587c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638775699859152309%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=n9acGwpNUyKmxVdhg3ZWpk5P9GNYioKXy2g4g4dyqqw%3D&reserved=0REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0178
Date of REC Opinion
29 Jul 2020
REC opinion
Further Information Favourable Opinion