Actively Recruiting

Phase 3
Age: 18Years - 99Years
All Genders
ID06700343

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety Between ABP 692 and Ocrevus4 (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis

Led by Amgen · Updated on 2026-05-29

444

Participants Needed

109

Research Sites

48 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pharmacokinetics and pharmacodynamics of ABP 692 compared to Ocrelizumab in people with relapsing-remitting multiple sclerosis (RRMS). The study aims to show that ABP 692 and Ocrelizumab have similar effects by measuring the suppression of new active brain lesions over 24 weeks using MRI scans. This is a phase 3, randomized, double-blind study sponsored by Amgen. Participants with RRMS will receive intravenous infusions of either ABP 692 or Ocrelizumab from the US or EU. The ABP 692 group receives 300 mg on Day 1 and Day 15, followed by 600 mg at Week 24. The Ocrelizumab (US) group receives 300 mg doses on Day 1 and Day 15, then switches to 600 mg of ABP 692 at Week 24. The Ocrelizumab (EU) group receives 300 mg on Day 1 and Day 15, then 600 mg at Week 24. Throughout the study, participants will undergo blood tests and MRI scans to monitor drug levels, brain lesions, and immune cell counts. Researchers will assess safety by tracking adverse events up to 96 weeks. The main outcomes include measuring drug concentration in the blood and counting new brain lesions during the first 24 weeks. Participants will be followed for safety and treatment effects up to nearly two years from the start of the study.

CONDITIONS

Brief Title

Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of relapsing-remitting multiple sclerosis according to the revised McDonald Criteria 2017
  • Expanded Disability Status Scale score between 0 and 5.5 inclusive at screening
  • Evidence of recent multiple sclerosis activity as defined by the study
  • Neurologically stable with no relapse within 28 days before randomization
Not Eligible

You will not qualify if you...

  • Diagnosis of primary progressive or secondary progressive multiple sclerosis
  • Multiple sclerosis duration of 10 years or more if Expanded Disability Status Scale score is 2.5 or less at screening
  • Contraindications to study procedures or medications
  • Use of prohibited medications as defined by the study
  • Significant concomitant disease requiring chronic systemic corticosteroids or immunosuppressants during the study
  • Current or history of significant medical conditions as described in the study
  • Abnormal laboratory blood values as defined by the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants receive intravenous infusions of either ABP 692 or Ocrelizumab for relapsing-remitting multiple sclerosis. The initial treatment includes two 300 mg doses given on Day 1 and Day 15, followed by a 600 mg dose at Week 24.

3 infusion visits: Day 1, Day 15, and Week 24

Follow-up

Duration - Up to 72 weeks after Week 24 infusion (total up to 96 weeks)

Participants are monitored for safety, clinical effects, and disease activity after treatment infusions.

Periodic visits for assessments up to Week 96

Trial Site Locations

Total: 109 locations

1

University of South Alabama

Mobile, Alabama, United States, 36617

Actively Recruiting

2

Clinical Endpoints, LLC

Scottsdale, Arizona, United States, 85258

Actively Recruiting

3

Profound Research - Neurology Center of Southern California

Carlsbad, California, United States, 92011

Actively Recruiting

4

Mountain Neurological Research Center

Basalt, Colorado, United States, 81621

Actively Recruiting

5

Advanced Neurosciences Research, Llc

Fort Collins, Colorado, United States, 80528

Actively Recruiting

6

Hasbani Neurology

New Haven, Connecticut, United States, 06511

Actively Recruiting

7

Neurology Offices of South Florida

Boca Raton, Florida, United States, 33428

Actively Recruiting

8

Aqualane Clinical Research

Naples, Florida, United States, 34105

Actively Recruiting

9

Emerald Coast Neurology/Synergy Clinical Research

Pensacola, Florida, United States, 32504

Actively Recruiting

10

Knight Neurology

Rockledge, Florida, United States, 32955

Actively Recruiting

11

Premiere Research Institute Palm Beach

West Palm Beach, Florida, United States, 33407

Actively Recruiting

12

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

Actively Recruiting

13

Rush University Medical Center, Rush University Cancer Center

Chicago, Illinois, United States, 60612-3841

Completed

14

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

15

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

16

Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills

Farmington, Michigan, United States, 48334-2979

Actively Recruiting

17

JFK Medical Center

Edison, New Jersey, United States, 08820

Actively Recruiting

18

Hackensack Meridian Health

Paramus, New Jersey, United States, 07652

Actively Recruiting

19

University of NM/Mind Imaging center

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

20

Triad Neurological Associates

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

21

Singlepoint Healthcare Opco, LLC

Columbus, Ohio, United States, 43235

Actively Recruiting

22

NDx Clinical Research, Inc

Dayton, Ohio, United States, 45459

Actively Recruiting

23

Premier Neurology, PC

Greenville, South Carolina, United States, 29650

Actively Recruiting

24

Hope Neurology

Knoxville, Tennessee, United States, 37922

Actively Recruiting

25

Vanderbilt University Medical Center (VUMC)

Nashville, Tennessee, United States, 37215

Actively Recruiting

26

Lone Star Neurology

Frisco, Texas, United States, 75035

Actively Recruiting

27

Froedtert Hospital-Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

28

Algemeen Ziekenhuis Delta

Roeselare, West-Vlaanderen, Belgium, 8800

Actively Recruiting

29

MS-Netwerk Limburg - Revalidatie & MS Centrum

Overpelt, Belgium, 3900

Actively Recruiting

30

Diagnostic Consultative Center Convex Ltd

Sofia, Sofiiska, Bulgaria, 1680

Actively Recruiting

31

UMHAT Dr.Georgi Stranski EAD

Pleven, Bulgaria, 5800

Actively Recruiting

32

University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski

Sofia, Bulgaria, 1431

Actively Recruiting

33

Medical Center Hera EOOD

Sofia, Bulgaria, 1510

Actively Recruiting

34

UMHATEM N.I. Pirogov

Sofia, Bulgaria, 1606

Actively Recruiting

35

Foothills Medical Centre

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

36

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

37

Sestre milosrdnice University Hospital Center

Zagreb, Croatia, 10000

Actively Recruiting

38

University Hospital Centre Zagreb

Zagreb, Croatia, 10000

Actively Recruiting

39

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia, 656 91

Actively Recruiting

40

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia, 500 05

Actively Recruiting

41

Privatni ordinace neurologie

Hradec Králové, Czechia, 50003

Actively Recruiting

42

Regional Hospital Jihlava

Jihlava, Czechia, 58601

Actively Recruiting

43

Nemocnice Teplice

Teplice, Czechia, 415 01

Actively Recruiting

44

Aarhus Universitetshospital, Skejby

Aarhus N, Central Jutland, Denmark, 8200

Actively Recruiting

45

Sydvestjysk Sygehus

Esbjerg, Region Syddanmark, Denmark, 6700

Actively Recruiting

46

Dansk Multipel Sklerose Center

Glostrup Municipality, Denmark, 2600

Actively Recruiting

47

Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

Nîmes, France, 30029

Actively Recruiting

48

LTD Pineo Medical Ecosystem

Tbilisi, Georgia, 0114

Actively Recruiting

49

Jo Ann University Hospital

Tbilisi, Georgia, 0159

Actively Recruiting

50

Zentrum fur klinische Forschung Dr.Scholl

Bad Homburg, Germany, 61348

Actively Recruiting

51

Studienzentrum Dr. Bischof GmbH

Böblingen, Germany, 71034

Actively Recruiting

52

University Hospital Carl Gustav Carus

Dresden, Germany, 01307

Actively Recruiting

53

Curiositas-ad-Sanum GmbH

Ebersberg, Germany, 85560

Actively Recruiting

54

Universitaetsklinikum Essen

Essen, Germany, 45147

Actively Recruiting

55

Klinische Forschung Hamburg GmbH

Hamburg, Germany, 20253

Actively Recruiting

56

Multipel Studies Institut fuer klinische Studien GbR

Hamburg, Germany, 22179

Actively Recruiting

57

Universitaetsklinikum Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

58

Universitaetsklinikum Leipzig

Leipzig, Germany, 04103

Actively Recruiting

59

Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg

Regensburg, Germany, 93059

Completed

60

ZNS Siegen GmbH

Siegen, Germany, 57076

Actively Recruiting

61

Neuropraxis Munchen Sud - Unterhaching

Unterhaching, Germany, 82008

Actively Recruiting

62

Bellaria-Maggiore Hospital-Azienda USL Bologna

Bologna, Italy, 40139

Actively Recruiting

63

Casa di Cura Privata del Policlinico Igea S.p.A

Milan, Italy, 20144

Actively Recruiting

64

Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi Mul

Naples, Italy, 80138

Actively Recruiting

65

Ospedale Sant'Andrea Hospital

Rome, Italy, 00189

Actively Recruiting

66

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, Lithuania, 50161

Actively Recruiting

67

Klaipedas University Hospital

Klaipėda, Lithuania, LT-92288

Actively Recruiting

68

Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079

Actively Recruiting

69

MA-LEK Clinical Sp. z o.o.

Katowice, Silesian Voivodeship, Poland, 40-571

Actively Recruiting

70

Neuro-Care

Katowice, Silesian Voivodeship, Poland, 40-749

Actively Recruiting

71

Neurocentrum Bydgoszcz

Bydgoszcz, Poland, 85-796

Actively Recruiting

72

Neuro Medic Clinic

Katowice, Poland, 40-686

Actively Recruiting

73

Resmedica Sp. z o.o.

Kielce, Poland, 25-726

Actively Recruiting

74

Krakowska Akademia Neurologii

Krakow, Poland, 31-505

Actively Recruiting

75

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland, 90-324

Actively Recruiting

76

NZOZ Neuromed M. i M. Nastaj Sp.P

Lublin, Poland, 20-064

Actively Recruiting

77

Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy

Poznan, Poland, 61-853

Actively Recruiting

78

Centrum Medyczne Neuroprotect

Warsaw, Poland, 01-684

Actively Recruiting

79

MTZ Clinical Research Powered by Pratia

Warsaw, Poland, 02-172

Actively Recruiting

80

ARENSIA Clinics

Bucharest, Romania, 011658

Actively Recruiting

81

ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca

Cluj-Napoca, Romania, 400006

Actively Recruiting

82

Clinical Hospital Center Zvezdara

Belgrade, Serbia, 11000

Actively Recruiting

83

University Clinical Centre of Kragujevac

Kragujevac, Serbia, 34000

Actively Recruiting

84

Clinic of Neurology, University Clinical Center Nis

Niš, Serbia, 18000

Actively Recruiting

85

Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)

Bratislava, Slovakia, 82626

Actively Recruiting

86

Neurologicka ambulancia Empathy, s.r.o.

Bratislava, Slovakia, 85101

Actively Recruiting

87

Fakultna Nemocnica Trnava

Trnava, Slovakia, 91775

Actively Recruiting

88

University Medical Centre Ljubljana-UKCL

Ljubljana, Slovenia, 1110

Actively Recruiting

89

Hospital Universitario Fundacion Alcorcon

Alcorcón, Spain, 28922

Actively Recruiting

90

Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)

Barcelona, Spain, 08036

Actively Recruiting

91

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, Spain, 41950

Actively Recruiting

92

Hospital de Denia Marina Salud

Dénia, Spain, 03700

Actively Recruiting

93

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, Spain, 28007

Actively Recruiting

94

Vithas Hospital Parque San Antonio

Malag, Spain, 29016

Actively Recruiting

95

Hospital Regional Universitario de Malaga

Málaga, Spain, 29010

Actively Recruiting

96

Hospital Santa Caterina

Salt, Spain, 17190

Actively Recruiting

97

Universidad de Sevilla - Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Actively Recruiting

98

Hospital Universitario de Torrejon

Torrejón de Ardoz, Spain, 28850

Actively Recruiting

99

Hospital Universitario Doctor Peset

Valencia, Spain, 46017

Actively Recruiting

100

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev

Valencia, Spain, 46026

Actively Recruiting

101

Hospital Alvaro Cunqueiro

Vigo, Spain, 36312

Actively Recruiting

102

MS Center Research Unit, Sahlgrenska University Hospital

Gothenburg, Sweden, 413 45

Actively Recruiting

103

Academic Specialist Center

Stockholm, Sweden, SE113 65

Completed

104

Universitaetsspital Bern - Inselspital

Bern, Switzerland, 3010

Actively Recruiting

105

Ospedale Regionale di Lugano, Sede Civico

Lugano, Switzerland, 6903

Actively Recruiting

106

Yeditepe University Kosuyolu Hospital

Kadıköy, Istanbul, Turkey (Türkiye), 34718

Actively Recruiting

107

Uludag University Medical Faculty

Bursa, Turkey (Türkiye), 16059

Actively Recruiting

108

Ondokuz Mayis University Health Practice and Research Hospital

Samsun, Turkey (Türkiye), 55280

Actively Recruiting

109

Arencia Exploratory Medicine

Kyiv, Ukraine, 01135

Actively Recruiting

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Research Team

A

Amgen Call Center

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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