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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032158
Recruitment Status : Terminated (Administrative reason by Sponsor.)
First Posted : July 25, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Tracking Information
First Submitted Date  ICMJE July 23, 2019
First Posted Date  ICMJE July 25, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE August 26, 2019
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • 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 Weeks 24, 48, and 96 ]
  • Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [ Time Frame: At Weeks 24, 48, and 96 ]
  • Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [ Time Frame: Baseline up to 96 weeks ]
  • Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score [ Time Frame: Baseline, Week 96 ]
  • Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score [ Time Frame: Baseline, Week 96 ]
  • Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 100 ]
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings [ Time Frame: Baseline up to Week 100 ]
    Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.
  • Absolute Concentrations of Immunoglobulin (Ig) Levels [ Time Frame: Baseline up to Week 100 ]
  • Change From Baseline in Immunoglobulin (Ig) Levels [ Time Frame: Baseline up to Week 100 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-remitting Multiple Sclerosis
Intervention  ICMJE
  • Drug: Evobrutinib
    Evobrutinib twice daily (BID) in double-blind treatment period.
    Other Name: M2951
  • Drug: Avonex®
    Avonex® once a week in double-blind treatment period.
  • Drug: Evobrutinib
    Evobrutinib BID in Open-Label Extension Period.
    Other Name: M2951
  • 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.
Study Arms  ICMJE
  • Experimental: Evobrutinib + Avonex® matched Placebo: Double-Blinded Period
    Interventions:
    • Drug: Evobrutinib
    • Drug: Placebo
  • Active Comparator: Avonex® + Evobrutinib matched Placebo: Double-Blinded Period
    Interventions:
    • Drug: Avonex®
    • Drug: Placebo
  • Experimental: Evobrutinib: Open-Label Extension Period
    Intervention: Drug: Evobrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 29, 2020)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2019)
950
Actual Study Completion Date  ICMJE April 16, 2020
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries Argentina,   Austria,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Czechia,   Estonia,   France,   Georgia,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Montenegro,   Poland,   Russian Federation,   Serbia,   Spain,   Taiwan,   Ukraine,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT04032158
Other Study ID Numbers  ICMJE MS200527_0073
2018-004701-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Study Sponsor  ICMJE EMD Serono Research & Development Institute, Inc.
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Medical Responsible Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP