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Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (EVOLUTION RMS2)

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ClinicalTrials.gov Identifier: NCT04032171
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
The study will evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with Relapsing Multiple Sclerosis (RMS).

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: Evobrutinib Drug: Avonex® Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 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 an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety
Estimated Study Start Date : August 19, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Evobrutinib + Avonex® matched Placebo: Double-Blinded Period Drug: Evobrutinib
Evobrutinib twice daily (BID) in double-blind treatment period.

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

Active Comparator: Avonex® + Evobrutinib matched Placebo: Double-Blinded Period Drug: Avonex®
Avonex® once a week in double-blind treatment period.

Drug: Placebo
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.




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 at 96 Weeks [ Time Frame: Baseline, Week 96 ]
  4. Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score at 96 Weeks [ Time Frame: Baseline, Week 96 ]
  5. Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [ Time Frame: At Week 24, 48 and 96 ]
  6. Total Number of New or Enlarging T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [ Time Frame: At Week 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 ]


Information from the National Library of Medicine

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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 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.

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): NCT04032171


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

Locations
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United States, Massachusetts
Please Contact U.S. Medical Information Not yet recruiting
Rockland, Massachusetts, United States, 02370
Germany
Please Contact the Communication Center Not yet recruiting
Darmstadt, Germany, 64293
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT04032171     History of Changes
Other Study ID Numbers: MS200527_0074
2018-004700-19 ( EudraCT Number )
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
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 is 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 EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Evobrutinib
Avonex®
Interferon-beta 1a
Relapsing Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic