Back to results

Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

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
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

NCT04338061

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

NCT04338061

Brief Title

Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

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 2)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2, 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 752

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Facility Name

Research Site 741

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Research Site 704

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Research Site 751

City

Hanford

State/Province

California

ZIP/Postal Code

93230

Country

United States

Facility Name

Research Site 737

City

West Hollywood

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Research Site 759

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Research Site 725

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Research Site 746

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32714

Country

United States

Facility Name

Research Site 718

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Research Site 702

City

Naples

State/Province

Florida

ZIP/Postal Code

34105

Country

United States

Facility Name

Research Site 740

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Research Site 726

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Research Site 719

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34243

Country

United States

Facility Name

Research Site 743

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Research Site 707

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Research Site 732

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Research Site 705

City

Weeki Wachee

State/Province

Florida

ZIP/Postal Code

34607

Country

United States

Facility Name

Research Site 753

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Research Site 742

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

Research Site 715

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Research Site 714

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

Research Site 744

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47904

Country

United States

Facility Name

Research Site 717

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

Research Site 735

City

Nicholasville

State/Province

Kentucky

ZIP/Postal Code

40356

Country

United States

Facility Name

Research Site 706

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Research Site 738

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Research Site 723

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Research Site 724

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Research Site 736

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28006

Country

United States

Facility Name

Research Site 712

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Research Site 728

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Research Site 711

City

Canton

State/Province

Ohio

ZIP/Postal Code

44735

Country

United States

Facility Name

Research Site 757

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Research Site 734

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Research Site 748

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Research Site 703

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Research Site 721

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Research Site 144

City

Gomel

Country

Belarus

Facility Name

Research Site 143

City

Grodno

Country

Belarus

Facility Name

Research Site 142

City

Minsk

Country

Belarus

Facility Name

Research Site 141

City

Vitebsk

Country

Belarus

Facility Name

Research Site 145

City

Vitebsk

Country

Belarus

Facility Name

Research Site 603

City

Belo Horizonte

Country

Brazil

Facility Name

Research Site 599

City

Curitiba

Country

Brazil

Facility Name

Research Site 604

City

Goiânia

Country

Brazil

Facility Name

Research Site 600

City

Joinville

Country

Brazil

Facility Name

Research Site 614

City

Passo Fundo

Country

Brazil

Facility Name

Research Site 591

City

Porto Alegre

Country

Brazil

Facility Name

Research Site 594

City

Porto Alegre

Country

Brazil

Facility Name

Research Site 596

City

Porto Alegre

Country

Brazil

Facility Name

Research Site 609

City

Vitória

Country

Brazil

Facility Name

Research Site 155

City

Blagoevgrad

Country

Bulgaria

Facility Name

Research Site 156

City

Dupnitsa

Country

Bulgaria

Facility Name

Research Site 157

City

Pleven

Country

Bulgaria

Facility Name

Research Site 801

City

Pleven

Country

Bulgaria

Facility Name

Research Site 804

City

Pleven

Country

Bulgaria

Facility Name

Research Site 805

City

Plovdiv

Country

Bulgaria

Facility Name

Research Site 151

City

Sofia

Country

Bulgaria

Facility Name

Research Site 152

City

Sofia

Country

Bulgaria

Facility Name

Research Site 153

City

Sofia

Country

Bulgaria

Facility Name

Research Site 158

City

Sofia

Country

Bulgaria

Facility Name

Research Site 159

City

Sofia

Country

Bulgaria

Facility Name

Research Site 160

City

Sofia

Country

Bulgaria

Facility Name

Research Site 802

City

Sofia

Country

Bulgaria

Facility Name

Research Site 803

City

Sofia

Country

Bulgaria

Facility Name

Research Site 808

City

Sofia

Country

Bulgaria

Facility Name

Research Site 154

City

Veliko Tarnovo

Country

Bulgaria

Facility Name

Research Site 106

City

Burnaby

Country

Canada

Facility Name

Research Site 107

City

London

Country

Canada

Facility Name

Research Site 105

City

Montreal

Country

Canada

Facility Name

Research Site 101

City

Ottawa

Country

Canada

Facility Name

Research Site 455

City

Bordeaux Cedex

Country

France

Facility Name

Research Site 459

City

Brest cedex 2

Country

France

Facility Name

Reserach Site 451

City

Clermont Ferrand Cedex

Country

France

Facility Name

Research Site 458

City

Limoges cedex

Country

France

Facility Name

Research Site 456

City

Nimes

Country

France

Facility Name

Research Site 453

City

Paris

Country

France

Facility Name

Research Site 457

City

Pringy cedex

Country

France

Facility Name

Research Site 452

City

Strasbourg cedex

Country

France

Facility Name

Research Site 454

City

Tours cedex 9

Country

France

Facility Name

Research Site 172

City

Augsburg

Country

Germany

Facility Name

Research Site 177

City

Berlin

Country

Germany

Facility Name

Research Site 180

City

Berlin

Country

Germany

Facility Name

Research Site 178

City

Bonn

Country

Germany

Facility Name

Research Site 184

City

Dresden

Country

Germany

Facility Name

Research Site 174

City

Hamburg

Country

Germany

Facility Name

Research Site 182

City

Heidelberg

Country

Germany

Facility Name

Research Site 179

City

Koeln

Country

Germany

Facility Name

Research Site 181

City

Leipzig

Country

Germany

Facility Name

Research Site 173

City

Mainz

Country

Germany

Facility Name

Research Site 176

City

Minden

Country

Germany

Facility Name

Research Site 171

City

Regensburg

Country

Germany

Facility Name

Research Site 183

City

Rostock

Country

Germany

Facility Name

Research Site 175

City

Tuebingen

Country

Germany

Facility Name

Research Site 194

City

Athens

Country

Greece

Facility Name

Research Site 196

City

Athens

Country

Greece

Facility Name

Research Site 197

City

Athens

Country

Greece

Facility Name

Research Site 201

City

Athens

Country

Greece

Facility Name

Research Site 202

City

Athens

Country

Greece

Facility Name

Research Site 205

City

Athens

Country

Greece

Facility Name

Research Site 207

City

Athens

Country

Greece

Facility Name

Reserach Site 206

City

Athens

Country

Greece

Facility Name

Research Site 198

City

Heraklion

Country

Greece

Facility Name

Research Site 204

City

Ioannina

Country

Greece

Facility Name

Research Site 192

City

Larissa

Country

Greece

Facility Name

Research Site 199

City

Marousi

Country

Greece

Facility Name

Research Site 191

City

Patras

Country

Greece

Facility Name

Research Site 203

City

Patra

Country

Greece

Facility Name

Research Site 195

City

Thessaloniki

Country

Greece

Facility Name

Research Site 445

City

Ahmedabad

Country

India

Facility Name

Research Site 444

City

Bangalore

Country

India

Facility Name

Research Site 443

City

Mangalore

Country

India

Facility Name

Research Site 442

City

New Delhi

Country

India

Facility Name

Research Site 218

City

Bari

Country

Italy

Facility Name

Research Site 216

City

Catania

Country

Italy

Facility Name

Research Site 214

City

Cefalù

Country

Italy

Facility Name

Research Site 219

City

Firenze

Country

Italy

Facility Name

Research Site 221

City

Milano

Country

Italy

Facility Name

Research Site 211

City

Napoli

Country

Italy

Facility Name

Research Site 215

City

Napoli

Country

Italy

Facility Name

Research Site 220

City

Orbassano

Country

Italy

Facility Name

Research Site 217

City

Palermo

Country

Italy

Facility Name

Research Site 212

City

Pozzilli

Country

Italy

Facility Name

Research Site 213

City

Roma

Country

Italy

Facility Name

Research Site 222

City

Roma

Country

Italy

Facility Name

Research Site 231

City

Riga

Country

Latvia

Facility Name

Research Site 232

City

Riga

Country

Latvia

Facility Name

Research Site 233

City

Riga

Country

Latvia

Facility Name

Research site 241

City

Kaunas

Country

Lithuania

Facility Name

Research site 244

City

Klaipeda

Country

Lithuania

Facility Name

Research site 243

City

Siauliai

Country

Lithuania

Facility Name

Research site 242

City

Vilnius

Country

Lithuania

Facility Name

Research Site 551

City

Kuala Lumpur

Country

Malaysia

Facility Name

Research Site 554

City

Kuala Lumpur

Country

Malaysia

Facility Name

Research Site 556

City

Kuala Lumpur

Country

Malaysia

Facility Name

Research Site 552

City

Kuching

Country

Malaysia

Facility Name

Research Site 553

City

Seberang Jaya

Country

Malaysia

Facility Name

Research Site 251

City

Chisinau

Country

Moldova, Republic of

Facility Name

Research Site 252

City

Chisinau

Country

Moldova, Republic of

Facility Name

Research Site 481

City

Bergen

Country

Norway

Facility Name

Research site 483

City

Drammen

Country

Norway

Facility Name

Research Site 482

City

Namsos

Country

Norway

Facility Name

Research Site 562

City

Baguio City

Country

Philippines

Facility Name

Research Site 561

City

Cebu City

Country

Philippines

Facility Name

Reserach Site 267

City

Bydgoszcz

Country

Poland

Facility Name

Reserach Site 268

City

Bydgoszcz

Country

Poland

Facility Name

Research site 274

City

Katowice-Ochojec

Country

Poland

Facility Name

Research Site 273

City

Katowice

Country

Poland

Facility Name

Research site 846

City

Katowice

Country

Poland

Facility Name

Research Site 276

City

Krakow

Country

Poland

Facility Name

Research Site 263

City

Lodz

Country

Poland

Facility Name

Research Site 266

City

Nowa Sol

Country

Poland

Facility Name

Research Site 270

City

Poznan

Country

Poland

Facility Name

Research Site 262

City

Rzeszow

Country

Poland

Facility Name

Research Site 265

City

Siemianowice

Country

Poland

Facility Name

Research Site 271

City

Szczecin

Country

Poland

Facility Name

Research Site 264

City

Warszawa

Country

Poland

Facility Name

Research Site 277

City

Warszawa

Country

Poland

Facility Name

Reserach Site 275

City

Warszawa

Country

Poland

Facility Name

Research Site 261

City

Zabrze

Country

Poland

Facility Name

Research Site 278

City

Zamosc

Country

Poland

Facility Name

Research Site 272

City

Łódź

Country

Poland

Facility Name

Research Site 293

City

Aveiro

Country

Portugal

Facility Name

Research Site 282

City

Braga

Country

Portugal

Facility Name

Research Site 289

City

Coimbra

Country

Portugal

Facility Name

Research Site 281

City

Lisboa

Country

Portugal

Facility Name

Research Site 283

City

Lisboa

Country

Portugal

Facility Name

Research Site 287

City

Lisboa

Country

Portugal

Facility Name

Research SIte 284

City

Matosinhos

Country

Portugal

Facility Name

Research Site 292

City

Porto

Country

Portugal

Facility Name

Research Site 288

City

Pragal

Country

Portugal

Facility Name

Research Site 291

City

Santa Maria da Feira

Country

Portugal

Facility Name

Research Site 286

City

Torres Vedras

Country

Portugal

Facility Name

Research Site 791

City

Guaynabo

Country

Puerto Rico

Facility Name

Research Site 314

City

Brasov

Country

Romania

Facility Name

Research Site 307

City

București

Country

Romania

Facility Name

Research Site 309

City

Caracal

Country

Romania

Facility Name

Research Site 302

City

Targu Mures

Country

Romania

Facility Name

Research Site 325

City

Kazan

Country

Russian Federation

Facility Name

Research Site 329

City

Kazan

Country

Russian Federation

Facility Name

Research Site 323

City

Kemerovo

Country

Russian Federation

Facility Name

Research Site 344

City

Kirov

Country

Russian Federation

Facility Name

Research Site 340

City

Krasnodar

Country

Russian Federation

Facility Name

Research Site 334

City

Krasnoyarsk

Country

Russian Federation

Facility Name

Research Site 341

City

Moscow

Country

Russian Federation

Facility Name

Research Site 343

City

Moscow

Country

Russian Federation

Facility Name

Research Site 345

City

Moscow

Country

Russian Federation

Facility Name

Research Site 332

City

Nizhniy Novgorod

Country

Russian Federation

Facility Name

Research Site 327

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site 330

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site 331

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site 335

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site 328

City

Rostov-on-Don

Country

Russian Federation

Facility Name

Research Site 346

City

Saint Petersburg

Country

Russian Federation

Facility Name

Research Site 324

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site 338

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site 339

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site 342

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site 326

City

Saransk

Country

Russian Federation

Facility Name

Research Site 321

City

Sestroretsk

Country

Russian Federation

Facility Name

Research Site 337

City

Tyumen

Country

Russian Federation

Facility Name

Research Site 493

City

Riyadh

Country

Saudi Arabia

Facility Name

Research Site 571

City

Singapore

Country

Singapore

Facility Name

Research site 572

City

Singapore

Country

Singapore

Facility Name

Research Site 351

City

Banska Bystrica

Country

Slovakia

Facility Name

Research Site 352

City

Bratislava

Country

Slovakia

Facility Name

Research Site 353

City

Bratislava

Country

Slovakia

Facility Name

Research Site 354

City

Bratislava

Country

Slovakia

Facility Name

Research Site 356

City

Bratislava

Country

Slovakia

Facility Name

Research Site 359

City

Dubnica nad Vahom

Country

Slovakia

Facility Name

Research Site 358

City

Trencin

Country

Slovakia

Facility Name

Research Site 357

City

Trnava

Country

Slovakia

Facility Name

Research Site 373

City

Celje

Country

Slovenia

Facility Name

Research Site 372

City

Ljubljana

Country

Slovenia

Facility Name

Research Site 371

City

Maribor

Country

Slovenia

Facility Name

Research Site 501

City

Cape Town

Country

South Africa

Facility Name

Research Site 502

City

Cape Town

Country

South Africa

Facility Name

Research Site 503

City

Cape Town

Country

South Africa

Facility Name

Research Site 504

City

Pretoria

Country

South Africa

Facility Name

Research Site 384

City

Alcorcon

Country

Spain

Facility Name

Research Site 391

City

Barakaldo

Country

Spain

Facility Name

Research Site 390

City

Barcelona

Country

Spain

Facility Name

Research Site 382

City

Cordoba

Country

Spain

Facility Name

Research Site 389

City

El Palmar

Country

Spain

Facility Name

Research Site 388

City

Madrid

Country

Spain

Facility Name

Research Site 392

City

Majadahonda

Country

Spain

Facility Name

Research Site 383

City

Malaga

Country

Spain

Facility Name

Research Site 387

City

Sevilla

Country

Spain

Facility Name

Research Site 385

City

Valencia

Country

Spain

Facility Name

Research Site 386

City

Valencia

Country

Spain

Facility Name

Research Site 381

City

Vigo

Country

Spain

Facility Name

Research Site 512

City

Göteborg

Country

Sweden

Facility Name

Research site 514

City

Malmö

Country

Sweden

Facility Name

Research Site 511

City

Stockholm

Country

Sweden

Facility Name

Research Site 513

City

Uppsala

Country

Sweden

Facility Name

Research Site 404

City

Aarau

Country

Switzerland

Facility Name

Research Site 402

City

Bern

Country

Switzerland

Facility Name

Research Site 403

City

Lugano

Country

Switzerland

Facility Name

Research Site 583

City

Bangkoknoi

Country

Thailand

Facility Name

Research Site 582

City

Muang

Country

Thailand

Facility Name

Research Site 538

City

Ankara

Country

Turkey

Facility Name

Research Site 544

City

Ankara

Country

Turkey

Facility Name

Research Site 531

City

Istanbul

Country

Turkey

Facility Name

Research Site 534

City

Istanbul

Country

Turkey

Facility Name

Research Site 536

City

Istanbul

Country

Turkey

Facility Name

Research Site 541

City

Istanbul

Country

Turkey

Facility Name

Research Site 543

City

Istanbul

Country

Turkey

Facility Name

Research Site 539

City

Izmir

Country

Turkey

Facility Name

Research Site 533

City

Kocaeli

Country

Turkey

Facility Name

Research Site 537

City

Konya

Country

Turkey

Facility Name

Research Site 540

City

Mersin

Country

Turkey

Facility Name

Research Site 535

City

Samsun

Country

Turkey

Facility Name

Research Site 532

City

Trabzon

Country

Turkey

Facility Name

Research Site 415

City

Chernihiv

Country

Ukraine

Facility Name

Research Site 417

City

Chernihiv

Country

Ukraine

Facility Name

Research Site 414

City

Dnipro

Country

Ukraine

Facility Name

Research Site 416

City

Dnipro

Country

Ukraine

Facility Name

Research Site 420

City

Dnipro

Country

Ukraine

Facility Name

Research Site 413

City

Ivano-Frankivsk

Country

Ukraine

Facility Name

Research Site 624

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 632

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 633

City

Kharkiv

Country

Ukraine

Facility Name

Research Site 419

City

Kherson

Country

Ukraine

Facility Name

Research Site 411

City

Kyiv

Country

Ukraine

Facility Name

Research Site 418

City

Kyiv

Country

Ukraine

Facility Name

Research Site 629

City

Lutsk

Country

Ukraine

Facility Name

Research Site 627

City

Lviv

Country

Ukraine

Facility Name

Research Site 622

City

Poltava

Country

Ukraine

Facility Name

Research Site 625

City

Rivne

Country

Ukraine

Facility Name

Research Site 628

City

Ternopil

Country

Ukraine

Facility Name

Research Site 630

City

Uzhgorod

Country

Ukraine

Facility Name

Research Site 623

City

Vinnytsia

Country

Ukraine

Facility Name

Research Site 412

City

Zaporizhzhia

Country

Ukraine

Facility Name

Research Site 621

City

Zaporizhzhia

Country

Ukraine

Facility Name

Research Site 631

City

Zaporizhzhia

Country

Ukraine

Facility Name

Research Site 626

City

Zhytomyr

Country

Ukraine

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_0082

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 2)

We'll reach out to this number within 24 hrs

Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

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