NCT07074886Active, not recruitingPhase 2
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 193 (actual)
- First submitted
- 17 Jul 2025
- Start date
- 13 Nov 2025
- Primary completion date
- 17 Sept 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Multiple sclerosis
- NCT number
- NCT07074886
- EU CT number
- 2024-517980-22-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 193
- From 13 Nov 2025 to the primary completion date, 17 Sept 2026
- 54 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- Previous treatment with cladribine, atacicept, and alemtuzumab
- Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
- Any previous history of transplantation or anti-rejection therapy
Other illness
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
- Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)
Lab values
- Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons
Other
- Immunocompromised state
- Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
- Lack of peripheral venous access
Who the study is looking for
- Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
- Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (54)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Médico Rivarola IMR Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| IME - Instituto Médico Especializado Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro de Especialidades Neurológicas y Rehabilitación - CENyR Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Focus CECIC Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Sanatorio del Sur S.A. Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Instituto de Neurologia de Curitiba Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Clinica Neurologica e Neurocirurgica de Joinville Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
| Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto do Cerebro do Rio Grande do Sul Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Santa Casa de Misericordia de Salvador Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Centro de Pesquisas Clinicas - CPCLIN Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Ruhr University Coordinator of this site? Confirm its status | Bochum | Germany | Active, not recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Hospital General Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. Coordinator of this site? Confirm its status | Pozzilli | Italy | Active, not recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Neurociencias Estudios Clinicos S.C. Coordinator of this site? Confirm its status | Culiacán | Mexico | Unknown status |
| Inovacion y Desarrollo en ciencias de la salud Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Neurociencias PRISMA A.C. Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Neurocentrum Bydgoszcz sp. z o.o Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakowie | Poland | Active, not recruiting |
| Centrum Neurologii Krzysztof Selmaj Coordinator of this site? Confirm its status | Łódź | Poland | Active, not recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Active, not recruiting |
| Nmedis sp. z o.o. Coordinator of this site? Confirm its status | Rzeszów | Poland | Active, not recruiting |
| IBISMED Wielospecjalistyczne Centrum Medyczne Coordinator of this site? Confirm its status | Zabrze | Poland | Active, not recruiting |
| ProNeuro Centrum Medyczne Coordinator of this site? Confirm its status | Zory | Poland | Active, not recruiting |
| Johns Hopkins University School Of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Profound Research LLC Coordinator of this site? Confirm its status | Carlsbad | United States | Unknown status |
| Advanced Neurology of Colorado, LLC Coordinator of this site? Confirm its status | Fort Collins | United States | Unknown status |
| Hope Neurology Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Neurology Associates PA Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| University of Massachusetts Medical School Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.