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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04338022




Registration number
NCT04338022
Ethics application status
Date submitted
6/04/2020
Date registered
8/04/2020
Date last updated
29/04/2024

Titles & IDs
Public title
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)
Scientific 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 (evolutionRMS 1)
Secondary ID [1] 0 0
2019-004972-20
Secondary ID [2] 0 0
MS200527_0080
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Evobrutinib
Treatment: Drugs - Placebo (match to Teriflunomide)
Treatment: Drugs - Teriflunomide
Treatment: Drugs - Placebo (match to Evobrutinib)

Experimental: Evobrutinib + Teriflunomide matched Placebo: DB Period -

Active comparator: Teriflunomide + Evobrutinib matched Placebo: DB Period -


Treatment: Drugs: Evobrutinib
Evobrutinib twice daily (BID) in DBTP.

Treatment: Drugs: Placebo (match to Teriflunomide)
Placebo match to Teriflunomide once daily in DBTP.

Treatment: Drugs: Teriflunomide
Teriflunomide once daily in DBTP.

Treatment: Drugs: Placebo (match to Evobrutinib)
Placebo match to Evobrutinib BID in DBTP.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DBTP: Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
Up to 156 weeks
Primary outcome [2] 0 0
DBE Period: ARR
Timepoint [2] 0 0
Up to 96 weeks
Primary outcome [3] 0 0
OLE Period: Number of Participants with Adverse Events and Serious Adverse Events (SAE)s
Timepoint [3] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [1] 0 0
DBTP: Time to First Occurrence of 12-Week Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) Progression
Timepoint [1] 0 0
Up to 156 weeks
Secondary outcome [2] 0 0
DBTP: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression
Timepoint [2] 0 0
Up to 156 weeks
Secondary outcome [3] 0 0
DBTP: Time to First Occurrence of 24-Week Confirmed Disability Improvement (CDI) as measured by EDSS Improvement
Timepoint [3] 0 0
Up to 156 weeks
Secondary outcome [4] 0 0
DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score
Timepoint [4] 0 0
Baseline up to 96 weeks
Secondary outcome [5] 0 0
DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score
Timepoint [5] 0 0
Baseline up to 96 weeks
Secondary outcome [6] 0 0
DBTP: Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by all Available Magnetic Resonance Imaging (MRI) Scans
Timepoint [6] 0 0
Up to Week 156
Secondary outcome [7] 0 0
DBTP: Total Number of New or Enlarging T2 Lesions Assessed by the Last Available Magnetic Resonance Imaging (MRI) Scan Relative to Baseline MRI Scan
Timepoint [7] 0 0
Up to Week 156
Secondary outcome [8] 0 0
DBTP: Neurofilament light chain (NfL) Serum Concentration
Timepoint [8] 0 0
At Week 12
Secondary outcome [9] 0 0
DBTP: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Timepoint [9] 0 0
Baseline up to 156 weeks
Secondary outcome [10] 0 0
DBTP: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Timepoint [10] 0 0
Baseline up to 156 weeks
Secondary outcome [11] 0 0
DBTP: Absolute Concentrations of Immunoglobulin (Ig) Levels
Timepoint [11] 0 0
Baseline up to 156 weeks
Secondary outcome [12] 0 0
DBTP: Change From Baseline in Immunoglobulin (Ig) Levels
Timepoint [12] 0 0
Baseline up to 156 weeks
Secondary outcome [13] 0 0
DBE Period: Time to First Occurrence of 12-Week CDP as measured by EDSS Progression
Timepoint [13] 0 0
Up to 96 weeks
Secondary outcome [14] 0 0
DBE Period: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression
Timepoint [14] 0 0
Up to 96 weeks
Secondary outcome [15] 0 0
DBE Period: Time to First Occurrence of 24-Week CDI as measured by EDSS Improvement
Timepoint [15] 0 0
Up to 96 weeks
Secondary outcome [16] 0 0
DBE Period: Change From Baseline in PROMIS MS PF Short Form Score
Timepoint [16] 0 0
Baseline up to 96 weeks
Secondary outcome [17] 0 0
DBE Period: Change From Baseline in PROMIS MS Fatigue Short Form Score
Timepoint [17] 0 0
Baseline up to 96 weeks
Secondary outcome [18] 0 0
DBE Period: Total Number of Gd+ T1 Lesions Assessed by all Available MRI Scans
Timepoint [18] 0 0
Up to Week 96
Secondary outcome [19] 0 0
DBE Period: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available MRI Scans Relative to Baseline MRI Scan
Timepoint [19] 0 0
Up to Week 96
Secondary outcome [20] 0 0
DBE Period: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Timepoint [20] 0 0
Baseline up to 96 weeks
Secondary outcome [21] 0 0
DBE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Timepoint [21] 0 0
Baseline up to 96 weeks
Secondary outcome [22] 0 0
DBE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels
Timepoint [22] 0 0
Baseline up to 96 weeks
Secondary outcome [23] 0 0
DBE Period: Change From Baseline in Immunoglobulin (Ig) Levels
Timepoint [23] 0 0
Baseline up to 96 weeks
Secondary outcome [24] 0 0
OLE Period: ARR based on protocol-defined qualified relapses
Timepoint [24] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [25] 0 0
OLE Period: Time to first occurrence of 24-week CDP as measured by EDSS
Timepoint [25] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [26] 0 0
OLE Period: Time to first occurrence of 24-week CDI as measured by EDSS
Timepoint [26] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [27] 0 0
OLE Period: Symbol Digital Modalities Test Over time
Timepoint [27] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [28] 0 0
OLE Period: PROMISnq PF (MS) 15a score change over time
Timepoint [28] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [29] 0 0
OLE Period: PROMIS Fatigue (MS) 8a Score Change Over Time
Timepoint [29] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [30] 0 0
OLE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Findings
Timepoint [30] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [31] 0 0
OLE: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available Magnetic Resonance Imaging (MRI) Scans
Timepoint [31] 0 0
Baseline OLE up to 96 weeks
Secondary outcome [32] 0 0
OLE: Change from Baseline in T2 lesion Volume Over Time
Timepoint [32] 0 0
Baseline OLE up to 96 weeks

Eligibility
Key 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 (Day 1)
* 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 and Baseline (Day 1)
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/03/2024
Sample size
Target
Accrual to date
Final
1124
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site 104 - Auchenflower
Recruitment hospital [2] 0 0
Research Site 107 - Concord
Recruitment hospital [3] 0 0
Research Site 109 - Hobart
Recruitment hospital [4] 0 0
Research Site 101 - Liverpool
Recruitment hospital [5] 0 0
Research Site 102 - New Lambton Heights
Recruitment hospital [6] 0 0
Research Site 103 - St Leonards
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Liverpool
Recruitment postcode(s) [5] 0 0
- New Lambton Heights
Recruitment postcode(s) [6] 0 0
- St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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California
Country [4] 0 0
United States of America
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Connecticut
Country [5] 0 0
United States of America
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District of Columbia
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United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Utah
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Virginia
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Wisconsin
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Cordoba
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Argentina
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Godoy Cruz
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Argentina
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Guaymallen
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Argentina
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Rosario
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Salta
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San Juan
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San Miguel de Tucuman
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Innsbruck
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Linz
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Mostar
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Varazdin
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Zagreb
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Hradec Kralove
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Pardubice
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Plzen-Bory
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Praha 10
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Czechia
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Praha 2
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Czechia
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Praha 4 - Krc
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Tallinn
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Rennes cedex 09
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France
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Rouen Cedex
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France
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Toulouse cedex 9
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Georgia
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Tbilisi
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Germany
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Bamberg
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Germany
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Bayreuth
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Germany
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Bochum
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Bonn
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Germany
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Erbach
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Essen
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Frankfurt
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Hannover
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Mannheim
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Muenchen
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Muenster
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Potsdam
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Siegen
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Ulm
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Hong Kong
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Hong Kong
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Hongkong
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Shatin
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Hungary
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Budapest
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Kistarcsa
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Hungary
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Pecs
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Tatabanya
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Vac
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India
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Hyderabad
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India
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Nashik
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India
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Ashkelon
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Israel
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Jerusalem
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Petah Tikva
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Ramat Gan
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Israel
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Rechovot
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Israel
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Safed
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Italy
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Bologna
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Chieti
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Genova
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Messina
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Milano
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Montichiari
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Napoli
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Italy
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Reggio Calabria
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Italy
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Roma
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Italy
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Salerno
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Italy
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Verona
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Mexico
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Aguascalientes
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Mexico
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Culiacan
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Netherlands
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Hoorn
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Netherlands
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Nieuwegein
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Rotterdam
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Sittard-Geleen
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Lodz
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Lublin
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Oswiecim
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Rzeszów
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Poland
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Warszawa
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Kaluga
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Kazan
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Russian Federation
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Kirov
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Perm
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Pyatigorsk
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Saint-Petersburg
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Saratov
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Smolensk
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St.Petersburg
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Tomsk
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Ufa
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
EMD Serono Research & Development Institute, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.
Trial website
https://clinicaltrials.gov/study/NCT04338022
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04338022