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NCT Number: NCT07074886

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro de Especialidades Neurológicas y Rehabilitación - CENyR, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Ocrelizumab Test Formulation

Drug

Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.

Other names: RO4964913

Ocrelizumab Reference Formulation

Drug

Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.

Other names: RO4964913

Primary outcomes

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

    Time frame: Up to 12 weeks

  2. Maximum Serum Concentration (Cmax) of Ocrelizumab

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 168 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: CN45320 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S.)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: PORTAMENTO

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Jul 20, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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