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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
Are there results?
Not yet: the study is under way

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
Show all 14Show fewer
  • 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

Other trials in United States

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

Other trials in Spain

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

Other trials in Italy

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

Other trials in Argentina

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

Other trials in Brazil

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

Other trials in Germany

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

Other trials in Poland

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

Other trials in Mexico

France2 sites

  • Hôpital Guillaume et René Laënnec

    Nantes, 44805

  • CHU de Nimes - Hopital Universitaire Caremeau

    Nîmes, 30900

Other trials in France

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.

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 groups in NCT07074886
Study groupRoleWhat they receive
Ocrelizumab Test FormulationExperimentalParticipants 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 FormulationActive comparatorParticipants 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.

  1. Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab

    Measured: Up to 12 weeks

  2. Maximum Serum Concentration (Cmax) of Ocrelizumab

    Measured: Up to 12 weeks

Secondary outcomes (1)

  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.

  1. First posted20 Jul 2025
  2. Study start13 Nov 2025
  3. Primary completion17 Sep 2026
  4. Study completion31 Mar 2030 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Spain, Italy, Argentina, Brazil and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07074886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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