Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT04032171
• Date of registration: 23/07/2019
• Prospective Registration: Yes
• Primary sponsor: EMD Serono Research & Development Institute, Inc.
• Public title: Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis
• Scientific 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
• Date of first enrolment: September 10, 2019
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT04032171
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Germany, United States

Contacts

• Name: Medical Responsible
• Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants 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 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis

Intervention(s)

Drug: Avonex®

Drug: Evobrutinib

Drug: Placebo

Primary Outcome(s)

Annualized Relapse Rate (ARR) [Time Frame: At Week 96]

Secondary Outcome(s)

Change From Baseline in Immunoglobulin (Ig) Levels [Time Frame: Baseline Up to Week 108]

Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings [Time Frame: Baseline Up to Week 108]

Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [Time Frame: Baseline up to 96 weeks]

Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [Time Frame: At Week 24, 48 and 96]

Absolute Concentrations of Immunoglobulin (Ig) Levels [Time Frame: Baseline Up to Week 108]

Number of Participants with Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) [Time Frame: Baseline Up to Week 108]

Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score [Time Frame: Baseline, Week 96]

Time to First Occurrence of 12-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [Time Frame: Baseline up to 96 weeks]

Total Number of New or Enlarging T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [Time Frame: At Week 24, 48 and 96]

Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score [Time Frame: Baseline, Week 96]

Secondary ID(s)

2018-004700-19

MS200527_0074

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck KGaA, Darmstadt, Germany