Multiple SclerosisPhase 2PORTAMENTONCT07074886
A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
A Phase 2 study testing Ocrelizumab Test Formulation and Ocrelizumab Reference Formulation in people with Multiple Sclerosis, run by Hoffmann-La Roche at 49 sites in 9 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ocrelizumab Test Formulation and Ocrelizumab Reference Formulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 49 sitesin 9 countries
- Study dates
- 13 Nov 2025to 31 Mar 2030
- Phase
- Phase 2
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening
- 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
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- Immunocompromised state
- Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
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- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
- Lack of peripheral venous access
- 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
- Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
United States9 sites
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21287
Profound Research, LLC
Carlsbad, California, 92011
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, 80528
Hope Neurology
Knoxville, Tennessee, 37922
Neurology Associates PA
Maitland, Florida, 32751
Swedish Medical Center
Seattle, Washington, 98122
SUNY Upstate Medical University
Syracuse, New York, 13210
University of South Florida
Tampa, Florida, 33612
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
Spain8 sites
Hospital General Universitario de Albacete
Albacete, DUMMY_VALUE
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, 08035
Hospital Universitario Virgen de Arrixaca
EL Palmar (EL Palmar), Murcia, 30120
Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, LAS Palmas, 35010
Hospital Universitario de la Princesa
Madrid, 28006
Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario Virgen Macarena
Seville, 41007
Italy7 sites
AO.U. Policlinico Riuniti Foggia
Foggia, Apulia, 71100
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, 20133
AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2
Naples, Campania, 80131
Università degli studi della Campania Luigi Vanvitelli
Naples, Campania, 80138
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, 86077
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, 00133
NCL Institute Neuroscience
Rome, Lazio, 00178
Argentina6 sites
Instituto Médico Rivarola IMR
Buenos Aires, C1015AAB
IME - Instituto Médico Especializado
Buenos Aires, C1405BCH
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
CABA, Buenos Aires, C1424BYD
Focus CECIC
CABA, CABA / Buenos Aires, C1425BKU
INECO Neurociencias Orono
Rosario, Santa Fe Province, S2000DTC
Sanatorio del Sur S.A.
San Miguel de Tucumán, T4000IDK
Brazil6 sites
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville, Santa Catarina, 89202-165
Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda
Porto Alegre, Rio Grande do Sul, 90110-000
Instituto do Cerebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, 40050-410
Centro de Pesquisas Clinicas - CPCLIN
São Paulo, São Paulo, 01244-030
Germany4 sites
Charite - Universitätsmedizin Berlin
Berlin, 12203
St. Josef-Hospital, Klinik für Neurologie
Bochum, 44791
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, 01307
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076
Poland4 sites
ProNeuro Centrum Medyczne
?ory, 44-240
Neurocentrum Bydgoszcz sp z o.o
Bydgoszcz, 85-796
Centrum Neurologii Krzysztof Selmaj
Lodz, 90-324
IBISMED Wielospecjalistyczne Centrum Medyczne
Zabrze, 41-800
Mexico3 sites
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, 80020
Inovacion y Desarrollo en ciencias de la salud
Mexico City, Mexico CITY (federal District), 14090
Neurociencias Prisma, A.C
San Luis Potosí City, San Luis Potosí, 78216
France2 sites
Hôpital Guillaume et René Laënnec
Nantes, 44805
CHU de Nimes - Hopital Universitaire Caremeau
Nîmes, 30900
About this study
Official title: A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab Test Formulation, Ocrelizumab Reference Formulation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocrelizumab Test FormulationDrug
Also called RO4964913
Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
Ocrelizumab Reference FormulationDrug
Also called RO4964913
Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab Test Formulation | Experimental | Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase. Receives: Drug: Ocrelizumab Test Formulation |
| Ocrelizumab Reference Formulation | Active comparator | Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase. Receives: Drug: Ocrelizumab Test Formulation; Drug: Ocrelizumab Reference Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab
Measured: Up to 12 weeks
Maximum Serum Concentration (Cmax) of Ocrelizumab
Measured: Up to 12 weeks
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs)
Measured: Up to 168 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start13 Nov 2025
- Primary completion17 Sep 2026
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074886
- Sponsor's protocol ID
- CN45320
- Other IDs
- 2024-517980-22-00
- Acronym
- PORTAMENTO
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing