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

Study Purpose

The study is 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04032158
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	EMD Serono Research & Development Institute, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Responsible
Principal Investigator Affiliation	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Estonia, France, Georgia, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, Montenegro, Poland, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing-remitting Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Evobrutinib + Avonex® matched Placebo: Double-Blinded Period

Active Comparator: Avonex® + Evobrutinib matched Placebo: Double-Blinded Period

Experimental: Evobrutinib: Open-Label Extension Period

Interventions

Drug: - Evobrutinib

Evobrutinib twice daily (BID) in double-blind treatment period.

Drug: - Avonex®

Avonex® once a week in double-blind treatment period.

Drug: - Evobrutinib

Evobrutinib BID in Open-Label Extension Period.

Drug: - Placebo

Placebo match to Avonex® once a week in double-blind treatment period.

Drug: - Placebo

Placebo match to Evobrutinib BID in double-blind treatment period.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of South Alabama, Mobile, Alabama

Status

Not yet recruiting

Address

University of South Alabama

Mobile, Alabama, 36693

Site Contact

William Kilgo

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