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Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Primary Purpose

Relapsing Multiple Sclerosis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Evobrutinib

Placebo (match to Teriflunomide)

Teriflunomide

Placebo (match to Evobrutinib)

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis focused on measuring Evobrutinib, Teriflunomide, Aubagio®, Relapsing Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evobrutinib + Teriflunomide matched Placebo: DB Period

Teriflunomide + Evobrutinib matched Placebo: DB Period

Arm Description

Outcomes

Primary Outcome Measures

DBTP: Annualized Relapse Rate (ARR)

The annualized relapse rates up to 156 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).

DBE Period: ARR

The annualized relapse rates up to 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).

OLE Period: Number of Participants with Adverse Events and Serious Adverse Events (SAE)s

Secondary Outcome Measures

DBTP: Time to First Occurrence of 12-Week Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) Progression

DBTP: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression

DBTP: Time to First Occurrence of 24-Week Confirmed Disability Improvement (CDI) as measured by EDSS Improvement

DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score

DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score

DBTP: Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by all Available Magnetic Resonance Imaging (MRI) Scans

DBTP: Total Number of New or Enlarging T2 Lesions Assessed by the Last Available Magnetic Resonance Imaging (MRI) Scan Relative to Baseline MRI Scan

DBTP: Neurofilament light chain (NfL) Serum Concentration

DBTP: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.

DBTP: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings

Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.

DBTP: Absolute Concentrations of Immunoglobulin (Ig) Levels

DBTP: Change From Baseline in Immunoglobulin (Ig) Levels

DBE Period: Time to First Occurrence of 12-Week CDP as measured by EDSS Progression

DBE Period: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression

DBE Period: Time to First Occurrence of 24-Week CDI as measured by EDSS Improvement

DBE Period: Change From Baseline in PROMIS MS PF Short Form Score

DBE Period: Change From Baseline in PROMIS MS Fatigue Short Form Score

DBE Period: Total Number of Gd+ T1 Lesions Assessed by all Available MRI Scans

DBE Period: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available MRI Scans Relative to Baseline MRI Scan

DBE Period: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.

DBE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings

Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.

DBE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels

DBE Period: Change From Baseline in Immunoglobulin (Ig) Levels

OLE Period: ARR based on protocol-defined qualified relapses

OLE Period: Time to first occurrence of 24-week CDP as measured by EDSS

OLE Period: Time to first occurrence of 24-week CDI as measured by EDSS

OLE Period: Symbol Digital Modalities Test Over time

OLE Period: PROMISnq PF (MS) 15a score change over time

OLE Period: PROMIS Fatigue (MS) 8a Score Change Over Time

OLE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Findings

OLE: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available Magnetic Resonance Imaging (MRI) Scans

OLE: Change from Baseline in T2 lesion Volume Over Time

Full Information

NCT ID

NCT04338022

First Posted

April 6, 2020

Last Updated

October 2, 2023

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Collaborators

EMD Serono Research & Development Institute, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04338022

Brief Title

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

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 (evolutionRMS 1)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 12, 2020 (Actual)

Primary Completion Date

October 2, 2023 (Actual)

Study Completion Date

June 26, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Collaborators

EMD Serono Research & Development Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Multiple Sclerosis

Keywords

Evobrutinib, Teriflunomide, Aubagio®, Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Evobrutinib + Teriflunomide matched Placebo: DB Period

Arm Type

Experimental

Arm Title

Teriflunomide + Evobrutinib matched Placebo: DB Period

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Evobrutinib

Other Intervention Name(s)

M2951

Intervention Description

Evobrutinib twice daily (BID) in DBTP.

Intervention Type

Drug

Intervention Name(s)

Placebo (match to Teriflunomide)

Intervention Description

Placebo match to Teriflunomide once daily in DBTP.

Intervention Type

Drug

Intervention Name(s)

Teriflunomide

Intervention Description

Teriflunomide once daily in DBTP.

Intervention Type

Drug

Intervention Name(s)

Placebo (match to Evobrutinib)

Intervention Description

Placebo match to Evobrutinib BID in DBTP.

Primary Outcome Measure Information:

Title

DBTP: Annualized Relapse Rate (ARR)

Description

Time Frame

Up to 156 weeks

Title

DBE Period: ARR

Description

Time Frame

Up to 96 weeks

Title

OLE Period: Number of Participants with Adverse Events and Serious Adverse Events (SAE)s

Time Frame

Baseline OLE up to 96 weeks

Secondary Outcome Measure Information:

Title

DBTP: Time to First Occurrence of 12-Week Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) Progression

Time Frame

Up to 156 weeks

Title

DBTP: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression

Time Frame

Up to 156 weeks

Title

DBTP: Time to First Occurrence of 24-Week Confirmed Disability Improvement (CDI) as measured by EDSS Improvement

Time Frame

Up to 156 weeks

Title

DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score

Time Frame

Baseline up to 96 weeks

Title

DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score

Time Frame

Baseline up to 96 weeks

Title

DBTP: Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by all Available Magnetic Resonance Imaging (MRI) Scans

Time Frame

Up to Week 156

Title

DBTP: Total Number of New or Enlarging T2 Lesions Assessed by the Last Available Magnetic Resonance Imaging (MRI) Scan Relative to Baseline MRI Scan

Time Frame

Up to Week 156

Title

DBTP: Neurofilament light chain (NfL) Serum Concentration

Time Frame

At Week 12

Title

DBTP: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

Description

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.

Time Frame

Baseline up to 156 weeks

Title

DBTP: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings

Description

Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.

Time Frame

Baseline up to 156 weeks

Title

DBTP: Absolute Concentrations of Immunoglobulin (Ig) Levels

Time Frame

Baseline up to 156 weeks

Title

DBTP: Change From Baseline in Immunoglobulin (Ig) Levels

Time Frame

Baseline up to 156 weeks

Title

DBE Period: Time to First Occurrence of 12-Week CDP as measured by EDSS Progression

Time Frame

Up to 96 weeks

Title

DBE Period: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression

Time Frame

Up to 96 weeks

Title

DBE Period: Time to First Occurrence of 24-Week CDI as measured by EDSS Improvement

Time Frame

Up to 96 weeks

Title

DBE Period: Change From Baseline in PROMIS MS PF Short Form Score

Time Frame

Baseline up to 96 weeks

Title

DBE Period: Change From Baseline in PROMIS MS Fatigue Short Form Score

Time Frame

Baseline up to 96 weeks

Title

DBE Period: Total Number of Gd+ T1 Lesions Assessed by all Available MRI Scans

Time Frame

Up to Week 96

Title

DBE Period: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available MRI Scans Relative to Baseline MRI Scan

Time Frame

Up to Week 96

Title

DBE Period: Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)

Description

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.

Time Frame

Baseline up to 96 weeks

Title

DBE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings

Description

Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.

Time Frame

Baseline up to 96 weeks

Title

DBE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels

Time Frame

Baseline up to 96 weeks

Title

DBE Period: Change From Baseline in Immunoglobulin (Ig) Levels

Time Frame

Baseline up to 96 weeks

Title

OLE Period: ARR based on protocol-defined qualified relapses

Time Frame

Baseline OLE up to 96 weeks

Title

OLE Period: Time to first occurrence of 24-week CDP as measured by EDSS

Time Frame

Baseline OLE up to 96 weeks

Title

OLE Period: Time to first occurrence of 24-week CDI as measured by EDSS

Time Frame

Baseline OLE up to 96 weeks

Title

OLE Period: Symbol Digital Modalities Test Over time

Time Frame

Baseline OLE up to 96 weeks

Title

OLE Period: PROMISnq PF (MS) 15a score change over time

Time Frame

Baseline OLE up to 96 weeks

Title

OLE Period: PROMIS Fatigue (MS) 8a Score Change Over Time

Time Frame

Baseline OLE up to 96 weeks

Title

OLE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Findings

Time Frame

Baseline OLE up to 96 weeks

Title

OLE: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available Magnetic Resonance Imaging (MRI) Scans

Time Frame

Baseline OLE up to 96 weeks

Title

OLE: Change from Baseline in T2 lesion Volume Over Time

Time Frame

Baseline OLE up to 96 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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 (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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Responsible

Organizational Affiliation

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Official's Role

Study Director

Facility Information:

Facility Name

Research Site 629

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36693-7003

Country

United States

Facility Name

Research Site 614

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Research Site 677

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Research Site 642

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Research Site 644

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Research Site 672

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

Research Site 634

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Research Site 656

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Research Site 616

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33428

Country

United States

Facility Name

Research Site 625

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Research Site 617

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Research Site 643

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Research site 645

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Research Site 652

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Research Site 621

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Research Site 649

City

Northbrook

State/Province

Illinois

ZIP/Postal Code

60062

Country

United States

Facility Name

Research Site 675

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61637

Country

United States

Facility Name

Research Site 628

City

Rolling Meadows

State/Province

Illinois

ZIP/Postal Code

60008

Country

United States

Facility Name

Research Site 624

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Research Site 632

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Research Site 653

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Research Site 623

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Research Site 633

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site 639

City

Foxboro

State/Province

Massachusetts

ZIP/Postal Code

02035

Country

United States

Facility Name

Research Site 635

City

Lawrence

State/Province

Massachusetts

ZIP/Postal Code

01843

Country

United States

Facility Name

Research Site 636

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Research Site 613

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Research Site 612

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Research Site 638

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Research Site 664

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

Research Site 668

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Research Site 626

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Research Site 667

City

Audubon

State/Province

New Jersey

ZIP/Postal Code

08106

Country

United States

Facility Name

Research Site 620

City

Patchogue

State/Province

New York

ZIP/Postal Code

11772

Country

United States

Facility Name

Research Site 663

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

Research Site 630

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614-2598

Country

United States

Facility Name

Research Site 611

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Research Site 641

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Research Site 615

City

Springfield

State/Province

Oregon

ZIP/Postal Code

97477

Country

United States

Facility Name

Research Site 647

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Research Site 648

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Facility Name

Research Site 627

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Research Site 637

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Research Site 662

City

Dallas

State/Province

Texas

ZIP/Postal Code

75214

Country

United States

Facility Name

Research Site 631

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site 650

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Research Site 619

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Research Site 676

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

Research Site 673

City

Alexandria

State/Province

Virginia

ZIP/Postal Code

22310

Country

United States

Facility Name

Research Site 654

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23456

Country

United States

Facility Name

Research Site 651

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226-3596

Country

United States

Facility Name

Research Site 566

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Research Site 567

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Research Site 574

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Research Site 579

City

Ciudad Autonoma Buenos Aires

Country

Argentina

Facility Name

Research Site 561

City

Ciudad Autonoma de Buenos Aires

Country

Argentina

Facility Name

Research Site 562

City

Ciudad Autonoma de Buenos Aires

Country

Argentina

Facility Name

Research Site 577

City

Ciudad Autonoma de Buenos Aires

Country

Argentina

Facility Name

Research Site 564

City

Cordoba

Country

Argentina

Facility Name

Research Site 568

City

Godoy Cruz

Country

Argentina

Facility Name

Research Site 576

City

Guaymallen

Country

Argentina

Facility Name

Research Site 565

City

Rosario

Country

Argentina

Facility Name

Research Site 569

City

Rosario

Country

Argentina

Facility Name

Research Site 571

City

Salta

Country

Argentina

Facility Name

Research Site 572

City

San Juan

Country

Argentina

Facility Name

Research Site 563

City

San Miguel de Tucuman

Country

Argentina

Facility Name

Research Site 104

City

Auchenflower

Country

Australia

Facility Name

Research Site 107

City

Concord

Country

Australia

Facility Name

Research Site 109

City

Hobart

Country

Australia

Facility Name

Research Site 101

City

Liverpool

Country

Australia

Facility Name

Research Site 102

City

New Lambton Heights

Country

Australia

Facility Name

Research Site 103

City

St Leonards

Country

Australia

Facility Name

Research Site 151

City

Innsbruck

Country

Austria

Facility Name

Research Site 156

City

Linz

Country

Austria

Facility Name

Research Site 154

City

Salzburg

Country

Austria

Facility Name

Research Site 153

City

Vienna

Country

Austria

Facility Name

Research Site 474

City

Bruxelles

Country

Belgium

Facility Name

Research Site 475

City

Bruxelles

Country

Belgium

Facility Name

Research Site 473

City

Kortrijk

Country

Belgium

Facility Name

Research Site 471

City

La Louvière

Country

Belgium

Facility Name

Research Site 472

City

Liège

Country

Belgium

Facility Name

Research Site 478

City

Overpelt

Country

Belgium

Facility Name

Research Site 476

City

Roeselare

Country

Belgium

Facility Name

Research Site 161

City

Bihac

Country

Bosnia and Herzegovina

Facility Name

Research Site 163

City

Mostar

Country

Bosnia and Herzegovina

Facility Name

Research Site 162

City

Sarajevo

Country

Bosnia and Herzegovina

Facility Name

Research Site 171

City

Pleven

Country

Bulgaria

Facility Name

Research Site 174

City

Pleven

Country

Bulgaria

Facility Name

Reasearch Site 175

City

Plovdiv

Country

Bulgaria

Facility Name

Research Site 177

City

Plovdiv

Country

Bulgaria

Facility Name

Research Site 172

City

Sofia

Country

Bulgaria

Facility Name

Research Site 173

City

Sofia

Country

Bulgaria

Facility Name

Research Site 176

City

Sofia

Country

Bulgaria

Facility Name

Research Site 178

City

Sofia

Country

Bulgaria

Facility Name

Research Site 179

City

Sofia

Country

Bulgaria

Facility Name

Research Site 180

City

Sofia

Country

Bulgaria

Facility Name

Research Site 126

City

Greenfield Park

Country

Canada

Facility Name

Research Site 125

City

Levis

Country

Canada

Facility Name

Research Site 128

City

Moncton

Country

Canada

Facility Name

Research Site 129

City

Montreal

Country

Canada

Facility Name

Research Site 124

City

Toronto

Country

Canada

Facility Name

Research Site 591

City

Barranquilla

Country

Colombia

Facility Name

Research Site 597

City

Barranquilla

Country

Colombia

Facility Name

Research Site 592

City

Medellin

Country

Colombia

Facility Name

Research Site 600

City

Medellin

Country

Colombia

Facility Name

Research Site 193

City

Osijek

Country

Croatia

Facility Name

Research Site 197

City

Rijeka

Country

Croatia

Facility Name

Research Site 195

City

Varazdin

Country

Croatia

Facility Name

Research Site 192

City

Zagreb

Country

Croatia

Facility Name

Research Site 194

City

Zagreb

Country

Croatia

Facility Name

Research Site 212

City

Brno

Country

Czechia

Facility Name

Research Site 218

City

Brno

Country

Czechia

Facility Name

Research Site 219

City

Hradec Kralove

Country

Czechia

Facility Name

Research Site 222

City

Hradec Kralove

Country

Czechia

Facility Name

Research Site 211

City

Jihlava

Country

Czechia

Facility Name

Research Site 223

City

Ostrava

Country

Czechia

Facility Name

Research Site 215

City

Pardubice

Country

Czechia

Facility Name

Research Site 216

City

Plzen-Bory

Country

Czechia

Facility Name

Research Site 217

City

Praha 10

Country

Czechia

Facility Name

Research Site 220

City

Praha 2

Country

Czechia

Facility Name

Research Site 213

City

Praha 4 - Krc

Country

Czechia

Facility Name

Research Site 224

City

Praha 5

Country

Czechia

Facility Name

Research Site 231

City

Tallinn

Country

Estonia

Facility Name

Research Site 232

City

Tartu

Country

Estonia

Facility Name

Research Site 491

City

Turku

Country

Finland

Facility Name

Research Site 510

City

Bron cedex

Country

France

Facility Name

Research Site 509

City

Caen cedex 9

Country

France

Facility Name

Research Site 502

City

Grenoble cedex 09

Country

France

Facility Name

Research Site 504

City

Lille cedex

Country

France

Facility Name

Research Site 508

City

Lille

Country

France

Facility Name

Reserach Site 505

City

Montpellier

Country

France

Facility Name

Research Site 511

City

Nantes cedex 1

Country

France

Facility Name

Research Site 506

City

Nice Cedex 1

Country

France

Facility Name

Research Site 507

City

Rennes cedex 09

Country

France

Facility Name

Research Site 501

City

Rouen Cedex

Country

France

Facility Name

Research Site 503

City

Toulouse cedex 9

Country

France

Facility Name

Research Site 241

City

Tbilisi

Country

Georgia

Facility Name

Research Site 242

City

Tbilisi

Country

Georgia

Facility Name

Research Site 243

City

Tbilisi

Country

Georgia

Facility Name

Research Site 244

City

Tbilisi

Country

Georgia

Facility Name

Research Site 245

City

Tbilisi

Country

Georgia

Facility Name

Research Site 246

City

Tbilisi

Country

Georgia

Facility Name

Research Site 247

City

Tbilisi

Country

Georgia

Facility Name

Research Site 248

City

Tbilisi

Country

Georgia

Facility Name

Research Site 249

City

Tbilisi

Country

Georgia

Facility Name

Research Site 250

City

Tbilisi

Country

Georgia

Facility Name

Research Site 265

City

Bamberg

Country

Germany

Facility Name

Research Site 267

City

Bayreuth

Country

Germany

Facility Name

Research Site 271

City

Berlin

Country

Germany

Facility Name

Research Site 264

City

Bochum

Country

Germany

Facility Name

Research Site 274

City

Bonn

Country

Germany

Facility Name

Research Site 270

City

Erbach

Country

Germany

Facility Name

Research Site 268

City

Essen

Country

Germany

Facility Name

Research Site 263

City

Frankfurt

Country

Germany

Facility Name

Research Site 275

City

Hannover

Country

Germany

Facility Name

Research Site 272

City

Mannheim

Country

Germany

Facility Name

Research Site 262

City

Muenchen

Country

Germany

Facility Name

Research Site 266

City

Muenster

Country

Germany

Facility Name

Research Site 261

City

Potsdam

Country

Germany

Facility Name

Research Site 273

City

Siegen

Country

Germany

Facility Name

Research Site 269

City

Ulm

Country

Germany

Facility Name

Research Site 700

City

Hong Kong

Country

Hong Kong

Facility Name

Research Site 704

City

Hongkong

Country

Hong Kong

Facility Name

Research Site 701

City

Shatin

Country

Hong Kong

Facility Name

Research Site 282

City

Budapest

Country

Hungary

Facility Name

Research Site 285

City

Budapest

Country

Hungary

Facility Name

Research Site 286

City

Budapest

Country

Hungary

Facility Name

Research Site 288

City

Budapest

Country

Hungary

Facility Name

Research Site 290

City

Budapest

Country

Hungary

Facility Name

Research Site 281

City

Kistarcsa

Country

Hungary

Facility Name

Research Site 284

City

Pecs

Country

Hungary

Facility Name

Research Site 289

City

Tatabanya

Country

Hungary

Facility Name

Research Site 291

City

Vac

Country

Hungary

Facility Name

Research Site 457

City

Hyderabad

Country

India

Facility Name

Research Site 456

City

Nashik

Country

India

Facility Name

Research Site 451

City

New Delhi

Country

India

Facility Name

Research Site 303

City

Ashkelon

Country

Israel

Facility Name

Research Site 305

City

Jerusalem

Country

Israel

Facility Name

Research Site 307

City

Petah Tikva

Country

Israel

Facility Name

Research Site 308

City

Ramat Gan

Country

Israel

Facility Name

Research Site 301

City

Rechovot

Country

Israel

Facility Name

Research Site 304

City

Safed

Country

Israel

Facility Name

Research Site 319

City

Bologna

Country

Italy

Facility Name

Research Site 321

City

Chieti

Country

Italy

Facility Name

Research Site 322

City

Genova

Country

Italy

Facility Name

Research Site 320

City

Messina

Country

Italy

Facility Name

Research Site 315

City

Milano

Country

Italy

Facility Name

Research Site 314

City

Montichiari

Country

Italy

Facility Name

Research Site 316

City

Napoli

Country

Italy

Facility Name

Research Site 317

City

Napoli

Country

Italy

Facility Name

Research Site 311

City

Reggio Calabria

Country

Italy

Facility Name

Research Site 318

City

Roma

Country

Italy

Facility Name

Research Site 312

City

Salerno

Country

Italy

Facility Name

Research Site 313

City

Verona

Country

Italy

Facility Name

Research Site 462

City

Goyang-si

Country

Korea, Republic of

Facility Name

Research Site 461

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site 463

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site 464

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site 465

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site 466

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site 467

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site 133

City

Aguascalientes

Country

Mexico

Facility Name

Research Site 134

City

Culiacan

Country

Mexico

Facility Name

Research Site 534

City

Hoorn

Country

Netherlands

Facility Name

Research Site 531

City

Nieuwegein

Country

Netherlands

Facility Name

Research Site 535

City

Rotterdam

Country

Netherlands

Facility Name

Research Site 532

City

Sittard-Geleen

Country

Netherlands

Facility Name

Research Site 332

City

Bydgoszcz

Country

Poland

Facility Name

Research Site 335

City

Gdansk

Country

Poland

Facility Name

Research Site 336

City

Katowice

Country

Poland

Facility Name

Research Site 340

City

Knurow

Country

Poland

Facility Name

Research Site 339

City

Lodz

Country

Poland

Facility Name

Research Site 337

City

Lublin

Country

Poland

Facility Name

Research Site 331

City

Oswiecim

Country

Poland

Facility Name

Research Site 338

City

Rzeszów

Country

Poland

Facility Name

Research Site 341

City

Warszawa

Country

Poland

Facility Name

Research Site 342

City

Warszawa

Country

Poland

Facility Name

Research Site 365

City

Barnaul

Country

Russian Federation

Facility Name

Research Site 368

City

Ekaterinburg

Country

Russian Federation

Facility Name

Research Site 355

City

Kaluga

Country

Russian Federation

Facility Name

Research Site 358

City

Kazan

Country

Russian Federation

Facility Name

Research Site 354

City

Kirov

Country

Russian Federation

Facility Name

Research Site 363

City

Krasnoyarsk

Country

Russian Federation

Facility Name

Research Site 353

City

Moscow

Country

Russian Federation

Facility Name

Research Site 359

City

Moscow

Country

Russian Federation

Facility Name

Research Site 352

City

Nizhniy Novgorod

Country

Russian Federation

Facility Name

Research Site 367

City

Perm

Country

Russian Federation

Facility Name

Research Site 362

City

Pyatigorsk

Country

Russian Federation

Facility Name

Research Site 369

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site 360

City

Saratov

Country

Russian Federation

Facility Name

Research Site 361

City

Smolensk

Country

Russian Federation

Facility Name

Research Site 356

City

St.Petersburg

Country

Russian Federation

Facility Name

Research Site 370

City

Tomsk

Country

Russian Federation

Facility Name

Research Site 351

City

Ufa

Country

Russian Federation

Facility Name

Research Site 357

City

Ulyanovsk

Country

Russian Federation

Facility Name

Research Site 366

City

Yaroslavl

Country

Russian Federation

Facility Name

Research Site 382

City

Belgrade

Country

Serbia

Facility Name

Research Site 383

City

Belgrade

Country

Serbia

Facility Name

Research Site 385

City

Belgrade

Country

Serbia

Facility Name

Research Site 389

City

Kragujevac

Country

Serbia

Facility Name

Research Site 390

City

Nis

Country

Serbia

Facility Name

Research Site 388

City

Novi Sad

Country

Serbia

Facility Name

Research Site 384

City

Uzice

Country

Serbia

Facility Name

Research Site 381

City

Valjevo

Country

Serbia

Facility Name

Research Site 406

City

Barcelona

Country

Spain

Facility Name

Research Site 407

City

Barcelona

Country

Spain

Facility Name

Research Site 405

City

Cadiz

Country

Spain

Facility Name

Research Site 401

City

Lleida

Country

Spain

Facility Name

Research Site 403

City

Madrid

Country

Spain

Facility Name

Research Site 408

City

Madrid

Country

Spain

Facility Name

Research Site 409

City

Madrid

Country

Spain

Facility Name

Research Site 411

City

Pozuelo de Alarcon

Country

Spain

Facility Name

Research Site 410

City

Salt

Country

Spain

Facility Name

Research Site 402

City

San Sebastian

Country

Spain

Facility Name

Research Site 404

City

Sevilla

Country

Spain

Facility Name

Research site 713

City

Kaohsiung

Country

Taiwan

Facility Name

Research Site 711

City

Taichung

Country

Taiwan

Facility Name

Research site 714

City

Taipei

Country

Taiwan

Facility Name

Research site 715

City

Taipei

Country

Taiwan

Facility Name

Research Site 432

City

Chernivtsi

Country

Ukraine

Facility Name

Research Site 425

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 429

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 430

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 435

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 436

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 437

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 422

City

Kropyvnytskyi

Country

Ukraine

Facility Name

Research Site 438

City

Kyiv

Country

Ukraine

Facility Name

Research Site 426

City

Lviv

Country

Ukraine

Facility Name

Research Site 424

City

Odesa

Country

Ukraine

Facility Name

Research Site 423

City

Poltava

Country

Ukraine

Facility Name

Research Site 427

City

Sumy

Country

Ukraine

Facility Name

Research Site 431

City

Vinnytsia

Country

Ukraine

Facility Name

Research Site 421

City

Zaporizhzhia

Country

Ukraine

Facility Name

Research Site 428

City

Zaporizhzhia

Country

Ukraine

Facility Name

Research Site 544

City

Exeter

Country

United Kingdom

Facility Name

Research Site 549

City

Glasgow

Country

United Kingdom

Facility Name

Research Site 552

City

Newcastle

Country

United Kingdom

Facility Name

Research Site 547

City

Swansea

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports 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 bit.ly/IPD21

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing URL

http://bit.ly/IPD21

Links:

URL

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200527_0080

Description

Trial Awareness and Transparency website

URL

https://medical.emdserono.com/en_US/home.html

Description

US Medical Information website, Medical Resources

Learn more about this trial

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

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Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Relapsing Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial