Relapsing-remitting Multiple Sclerosis (RRMS)Phase 3NCT06700343
Comparison Between ABP 692 and Ocrevus® (Ocrelizumab)
A Phase 3 study testing Ocrelizumab (US), Ocrelizumab (EU) and ABP 692 in people with Relapsing-remitting Multiple Sclerosis (RRMS), run by Amgen at 109 sites in 22 countries.
Trial summary
The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis (RRMS)
- What is being tested?
- Ocrelizumab (US), Ocrelizumab (EU) and ABP 692
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 109 sitesin 22 countries
- Study dates
- 13 Jan 2025to 4 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of RRMS in accordance with the revised McDonald Criteria 2017 (Thompson et al, 2018).
- Expanded Disability Status Scale score at screening ≥ 0 and ≤ 5.5 inclusive.
- Evidence of recent MS activity as defined by the study protocol.
- Neurologically stable subject, with no relapse for ≤ 28 days before randomization.
Who cannot join
- Diagnosis of primary progressive or with secondary progressive MS (Thompson et al, 2018).
- Multiple sclerosis disease duration of ≥ 10 years in Participants with Expanded Disability Status Scale (EDSS) score of ≤ 2.5 at screening.
- Any contraindications to study procedures or medications as outlined in the study protocol.
- Any prohibited medication as defined in the study protocol.
- Any significant concomitant disease that may require chronic treatment with systemic corticosteroids and/or systemic immunosuppressants during the study.
- Current or history of any significant medical conditions as described in the study protocol.
- Any abnormal laboratory blood values as defined in the study protocol.
Trial locations and contacts
109 sites in 22 countries.
109 sites in 22 countries
United States27 sites
University of NM/Mind Imaging center
Albuquerque, New Mexico, 87131
Mountain Neurological Research Center
Basalt, Colorado, 81621
Neurology Offices of South Florida
Boca Raton, Florida, 33428
Profound Research - Neurology Center of Southern California
Carlsbad, California, 92011
Rush University Medical Center, Rush University Cancer Center
Chicago, Illinois, 60612-3841
Singlepoint Healthcare Opco, LLC
Columbus, Ohio, 43235
NDx Clinical Research, Inc
Dayton, Ohio, 45459
Henry Ford Health
Detroit, Michigan, 48202
JFK Medical Center
Edison, New Jersey, 08820
Michigan Institute For Neurological Disorders (Glendale Neurological Associates) - Farmington Hills
Farmington, Michigan, 48334-2979
Advanced Neurosciences Research, Llc
Fort Collins, Colorado, 80528
Lone Star Neurology
Frisco, Texas, 75035
Premier Neurology, PC
Greenville, South Carolina, 29650
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
University of Kansas Medical Center
Kansas City, Kansas, 66160
Hope Neurology
Knoxville, Tennessee, 37922
Froedtert Hospital-Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of South Alabama
Mobile, Alabama, 36617
Aqualane Clinical Research
Naples, Florida, 34105
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37215
Hasbani Neurology
New Haven, Connecticut, 06511
Hackensack Meridian Health
Paramus, New Jersey, 07652
Emerald Coast Neurology/Synergy Clinical Research
Pensacola, Florida, 32504
Knight Neurology
Rockledge, Florida, 32955
Clinical Endpoints, LLC
Scottsdale, Arizona, 85258
Premiere Research Institute Palm Beach
West Palm Beach, Florida, 33407
Triad Neurological Associates
Winston-Salem, North Carolina, 27103
Spain13 sites
Hospital Universitario Fundacion Alcorcon
Alcorcón, 28922
Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)
Barcelona, 08036
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, 41950
Hospital de Denia Marina Salud
Dénia, 03700
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
Vithas Hospital Parque San Antonio
Malag, 29016
Hospital Regional Universitario de Malaga
Málaga, 29010
Hospital Santa Caterina
Salt, 17190
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario de Torrejon
Torrejón de Ardoz, 28850
Hospital Universitario Doctor Peset
Valencia, 46017
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulev
Valencia, 46026
Hospital Alvaro Cunqueiro
Vigo, 36312
Germany12 sites
Zentrum fur klinische Forschung Dr.Scholl
Bad Homburg, 61348
Studienzentrum Dr. Bischof GmbH
Böblingen, 71034
University Hospital Carl Gustav Carus
Dresden, 01307
Curiositas-ad-Sanum GmbH
Ebersberg, 85560
Universitaetsklinikum Essen
Essen, 45147
Klinische Forschung Hamburg GmbH
Hamburg, 20253
Multipel Studies Institut fuer klinische Studien GbR
Hamburg, 22179
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Universitaetsklinikum Leipzig
Leipzig, 04103
Praxisgemeinschaft fuer Neurologie, Psychiatrie und Psychotherapie - Regensburg
Regensburg, 93059
ZNS Siegen GmbH
Siegen, 57076
Neuropraxis Munchen Sud - Unterhaching
Unterhaching, 82008
Poland12 sites
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079
Neurocentrum Bydgoszcz
Bydgoszcz, 85-796
MA-LEK Clinical Sp. z o.o.
Katowice, Silesian Voivodeship, 40-571
Neuro-Care
Katowice, Silesian Voivodeship, 40-749
Neuro Medic Clinic
Katowice, 40-686
Resmedica Sp. z o.o.
Kielce, 25-726
Krakowska Akademia Neurologii
Krakow, 31-505
Centrum Neurologii Krzysztof Selmaj
Lodz, 90-324
NZOZ Neuromed M. i M. Nastaj Sp.P
Lublin, 20-064
Nzoz Neuro-Kard Ilkowski I Partnerzy Spolka Partnerska Lekarzy
Poznan, 61-853
Centrum Medyczne Neuroprotect
Warsaw, 01-684
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
Bulgaria5 sites
UMHAT Dr.Georgi Stranski EAD
Pleven, 5800
Diagnostic Consultative Center Convex Ltd
Sofia, Sofiiska, 1680
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
Sofia, 1431
Medical Center Hera EOOD
Sofia, 1510
UMHATEM N.I. Pirogov
Sofia, 1606
Czechia5 sites
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
Privatni ordinace neurologie
Hradec Králové, 50003
Regional Hospital Jihlava
Jihlava, 58601
Nemocnice Teplice
Teplice, 415 01
Italy4 sites
Bellaria-Maggiore Hospital-Azienda USL Bologna
Bologna, 40139
Casa di Cura Privata del Policlinico Igea S.p.A
Milan, 20144
Universita degli Studi della Campania Luigi Vanvitelli - Clinica Neurologia II - Centro Sclerosi Mul
Naples, 80138
Ospedale Sant'Andrea Hospital
Rome, 00189
Denmark3 sites
Aarhus Universitetshospital, Skejby
Aarhus N, Central Jutland, 8200
Sydvestjysk Sygehus
Esbjerg, Region Syddanmark, 6700
Dansk Multipel Sklerose Center
Glostrup Municipality, 2600
Serbia3 sites
Clinical Hospital Center Zvezdara
Belgrade, 11000
University Clinical Centre of Kragujevac
Kragujevac, 34000
Clinic of Neurology, University Clinical Center Nis
Niš, 18000
Slovakia3 sites
Nemocnica Ruzinov-Univerzitna Nemocnica Bratislava (UNB)
Bratislava, 82626
Neurologicka ambulancia Empathy, s.r.o.
Bratislava, 85101
Fakultna Nemocnica Trnava
Trnava, 91775
Turkey (Türkiye)3 sites
Uludag University Medical Faculty
Bursa, 16059
Yeditepe University Kosuyolu Hospital
Kadıköy, Istanbul, 34718
Ondokuz Mayis University Health Practice and Research Hospital
Samsun, 55280
Belgium2 sites
MS-Netwerk Limburg - Revalidatie & MS Centrum
Overpelt, 3900
Algemeen Ziekenhuis Delta
Roeselare, West-Vlaanderen, 8800
Canada2 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Croatia2 sites
Sestre milosrdnice University Hospital Center
Zagreb, 10000
University Hospital Centre Zagreb
Zagreb, 10000
Georgia2 sites
LTD Pineo Medical Ecosystem
Tbilisi, 0114
Jo Ann University Hospital
Tbilisi, 0159
Lithuania2 sites
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, 50161
Klaipedas University Hospital
Klaipėda, LT-92288
Romania2 sites
ARENSIA Clinics
Bucharest, 011658
ARENSIA Exploratory Medicine at County Hospital Cluj-Napoca
Cluj-Napoca, 400006
Sweden2 sites
MS Center Research Unit, Sahlgrenska University Hospital
Gothenburg, 413 45
Academic Specialist Center
Stockholm, SE113 65
Switzerland2 sites
Universitaetsspital Bern - Inselspital
Bern, 3010
Ospedale Regionale di Lugano, Sede Civico
Lugano, 6903
France1 site
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau
Nîmes, 30029
About this study
Official title: A Randomized, Double-blind Study to Demonstrate Pharmacokinetic Similarity, and Evaluate Safety, Immunogenicity, Pharmacodynamics, and Clinical Effects Between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects With Relapsing-remitting Multiple Sclerosis
The Main objectives of the study are to demonstrate pharmacokinetic (PK) similarity between ABP 692 and ocrelizumab (US), as well as between ABP 692 and ocrelizumab (EU).
- Being tested
- Ocrelizumab (US), Ocrelizumab (EU), ABP 692
- Keywords
- Neuroscience, Neurology, Neuroimmunology, Immunosuppressants, Ocrelizumab, ABP 692
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocrelizumab (US)Drug
IV infusion
Ocrelizumab (EU)Drug
IV infusion
ABP 692Drug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| ABP 692 | Experimental | Participants affected by relapsing-remitting multiple sclerosis (RRMS) will receive an initial dose of 300 mg ABP 692 intravenous (IV) infusion on Day 1, followed by a second dose of 300 mg ABP 692 IV infusion on Day 15. A subsequent dose of 600 mg ABP 692 IV infusion will be administered 24 weeks after the initial dose. Receives: Drug: ABP 692 |
| Ocrelizumab (US)/ABP 692 | Active comparator | Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (US) IV infusion on Day 1, followed by a second dose of 300 mg Ocrelizumab (US) IV infusion on Day 15. At Week 24, the treatment will switch to a 600 mg IV infusion of ABP 692. Receives: Drug: Ocrelizumab (US); Drug: ABP 692 |
| Ocrelizumab (EU) | Active comparator | Participants affected by RRMS will receive an initial dose of 300 mg Ocrelizumab (EU) IV infusion on Day 1, followed by a 300 mg Ocrelizumab (EU) IV infusion on Day 15. At Week 24, participants will receive a dose of 600 mg Ocrelizumab (EU) IV infusion. Receives: Drug: Ocrelizumab (EU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-time Curve (AUC) From Time 0 to Day15 (AUC0-d15) Following Infusion 1 ofthe Initial Dose of InvestigationalProduct (IP)
Measured: Day 1 to Day 15
AUC From Time 0 Extrapolated toInfinity (AUC0-inf) of the Entire Initial Dose of IP
Measured: Day 1 to Week 16
Secondary outcomes (24)
Maximum Concentration (Cmax) Following Infusion 1 of the Initial Dose of IP at Day 1 (Cmax, d1)
Measured: Day 1 to Day 15
Cmax Following Infusion 2 of theInitial Dose of IP at Day 15 (Cmax,d15)
Measured: Day 15 to Week 16
AUC of the Initial Dose From Time 0 to Week 16 (AUC0-wk16) of IP
Measured: Day 1 to Week 16
AUC of Infusion 2 of IP From Day 15 to Week 16 (AUCd15-wk16)
Measured: Day 15- Week 16
Time at Which Cmax, d1 (Tmax, d1) of IP is Observed
Measured: Day 1 to Day 15
Time at Which Cmax, d15 (Tmax, d15) of IP is Observed
Measured: Day 15 to Week 16
Trough Concentration (Ctrough) of IP at Day 15
Measured: Day 15
Clearance (CL) of IP
Measured: Day 1 to Week 16
Volume of Distribution (Vd) of IP
Measured: Day 1 to Week 16
Terminal Elimination Half-life (T1/2) of IP
Measured: Day 1 to Week 16
Mean Residence Time (MRT) of IP
Measured: Day 1 to Week 16
Total number of new gadolinium enhancing (GdE) T1-weighted lesions at week 12 and week 24
Measured: Up to Week 24
Total number of GdE T1-weighted lesions at week 12 and week 24
Measured: Up to Week 24
Total Number of New or Enlarging T2 Hyperintense Lesion at Week 12 and week 24
Measured: Up to Week 24
Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 24
Measured: At Week 24
Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 24
Measured: At Week 24
Percentage of Participants Achieving < 5 CD19+ B-cells/μL in Peripheral Blood at Week 48
Measured: At Week 48
Percentage of Participants Achieving < 10 CD19+ B-cells/μL in Peripheral Blood at Week 48
Measured: At Week 48
Percentage of Participants who are Relapse-free at Week 24
Measured: At Week 24
Percentage of Participants who are Relapse-free at Week 48
Measured: At Week 48
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a treatment, combination product, medical device, or procedure. A TEAE is defined as an AE that starts or worsens on or after the first IP infusion up to the end of study visit.
Measured: Up to Week 72
Number of Participants Experiencing Treatment-emergent Serious Adverse Events (TESAEs)
Measured: Up to Week 72
Number of Participants Experiencing Treatment-emergent Events of Interest (EOIs)
Measured: Up to Week 72
Percentage of Participants with Anti-drug Antibodies (ADAs)
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start13 Jan 2025
- Primary completion19 Apr 2027 (estimated)
- Study completion4 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple Sclerosis (RRMS)Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700343
- Sponsor's protocol ID
- 20230309
- Other IDs
- 2024-512914-16
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.