Brief Summary

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS).

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

Inclusion Criteria

Ages Eligible for Study: 18 Years to 55 Years (Adult)
Sexes Eligible for Study: All

• 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 Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) 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 or 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 and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
• Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
• Participants have given written informed consent prior to any study-related procedure

• Other protocol defined inclusion criteria could apply.

(from https://clinicaltrials.gov/ct2/show/NCT04338022)

Exclusion Criteria

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. (from https://clinicaltrials.gov/ct2/show/NCT04338022; see also EudraCT Number: 2019-004972-20)

Anticipated Start Date

Global actual start date 12 June 2020.

Recruitment Contacts

Liverpool Hospital, Liverpool, NSW
Investigator is Dr Suzanne Hodgkinson. Site contact is Meg Vandenheuvel: [email protected]

John Hunter Hospital, Newcastle, NSW
Investigator is Dr Jeannette Lechner-Scott. Site contact is Nicole Lingard: [email protected]

Royal North Shore Hospital, St Leonards, NSW
Investigator is Dr John Parratt. Site contact is Karen Thomas: [email protected]

Wesley Hospital, Auchenflower, QLD
Investigator is Dr Noel Saines. Site contact is Jacqui Langton: [email protected]

Concord Hospital, Concord, Sydney, NSW
Investigator is Dr Stephen Reddel. Site contact is Alison Craig: [email protected]

Menzies Institute for Medical Research, Hobart, TAS
Investigator Dr Bruce Taylor. Site contact is Katie De La Rue: [email protected]

Further details

Full details of the trial can be found on clinicaltrials.gov – ClinicalTrials.gov Identifier: NCT04338022

Four of the study sites are using an online survey to allow people to see if they might be eligible to participate in the trial. These sites are Liverpool Hospital, John Hunter Hospital, Royal North Shore Hospital & Wesley Hospital. To see if you might be eligible for the trial at these sites, a short survey is available here: https://au.evolutionstudies.com/#!/ If the survey results indicate you are potentially eligible for the trial, and you wish to provide your contact details, the nearest site would then contact you.

(Please note that if your post code is too far from these study sites, the website will not prompt you for your contact details and you will not be contacted. If this is the case you would need to contact the site directly on the emails provided above. Similarly if you wish to determine your eligibility for the trial at either Concord Hospital or Menzies Institute for Medical Research, you would need to contact the site directly).

Region

NSW/QLD/TAS

Ethics Approval

Yes

Last updated

14 June 2021