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Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS) (evolutionRMS 2)

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ClinicalTrials.gov Identifier: NCT04338061
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
EMD Serono Research & Development Institute, Inc.
Information provided by (Responsible Party):
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Description
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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).

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: Evobrutinib Drug: Placebo (match to Teriflunomide) Drug: Teriflunomide Drug: Placebo (match to Evobrutinib) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 930 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : September 18, 2023
Estimated Study Completion Date : July 10, 2026

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Evobrutinib + Teriflunomide matched Placebo: DB Period Drug: Evobrutinib
Evobrutinib twice daily (BID) in double-blind (DB) treatment period.
Other Name: M2951

Drug: Placebo (match to Teriflunomide)
Placebo match to Teriflunomide once daily in double-blind treatment period.
Active Comparator: Teriflunomide + Evobrutinib matched Placebo: DB Period Drug: Teriflunomide
Teriflunomide once daily in double-blind treatment period.

Drug: Placebo (match to Evobrutinib)
Placebo match to Evobrutinib BID in double-blind treatment period.
Experimental: Evobrutinib: Open-Label Extension Period Drug: Evobrutinib
Evobrutinib BID in Open-Label Extension Period.
Other Name: M2951


Outcome Measures
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Primary Outcome Measures :
  1. Annualized Relapse Rate (ARR) [ Time Frame: At Week 96 ]
    The annualized relapse rates over 96 weeks will be calculated based on qualified relapses. Qualifying relapse is defined as occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than 24 hours, no fever, infection, injury, adverse events, and preceded by a stable or improving neurological state for greater than or equal to (=>) 30 days).


Secondary Outcome Measures :
  1. Time to First Occurrence of 12-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [ Time Frame: Baseline up to 96 weeks ]
  2. Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [ Time Frame: Baseline up to 96 weeks ]
  3. Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score [ Time Frame: Baseline, Week 96 ]
  4. Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score [ Time Frame: Baseline, Week 96 ]
  5. Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [ Time Frame: At Weeks 24, 48, and 96 ]
  6. Total Number of New or Enlarging T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [ Time Frame: At Weeks 24, 48, and 96 ]
  7. Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 108 ]
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.

  8. Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings [ Time Frame: Baseline up to Week 108 ]
    Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.

  9. Absolute Concentrations of Immunoglobulin (Ig) Levels [ Time Frame: Baseline up to Week 108 ]
  10. Change From Baseline in Immunoglobulin (Ig) Levels [ Time Frame: Baseline up to Week 108 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338061


Contacts
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Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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Sponsors and Collaborators
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute, Inc.
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
More Information
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Additional Information:

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Responsible Party: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT04338061    
Other Study ID Numbers: MS200527_0082
2019-004980-36 ( EudraCT Number )
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our- approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data- sharing.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany:
Evobrutinib
Teriflunomide
Aubagio®
Relapsing Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases