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Tests treatment safety and results for Multiple Sclerosis
Official title A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis
ClinicalTrials.gov ID: NCT07667322
What this study is testing
What is Ocrelizumab Co-formulated With rHuPH20?
Ocrelizumab Co-formulated With rHuPH20 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple sclerosis.
Also referred to as RO4964913; Ocrevus®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria...
- Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
You likely can't join if
- Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening
- Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring...
- 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
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
See the full eligibility criteria
- Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
- Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
- Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening
- Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks...
- 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
- 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 (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant...
- Lack of peripheral venous access
- Previous treatment with cladribine, atacicept, and alemtuzumab
- Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline
- 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
- Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
The study team makes the final eligibility decision.
Where it's taking place
- Carlsbad, California, United States
- Maitland, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Knoxville, Tennessee, United States
- Curitiba, Paraná, Brazil
- São Paulo, São Paulo, Brazil
- Guadalajara, Jalisco, Mexico
- Mexico City, Mexico CITY (federal District), Mexico
- Nottingham, United Kingdom
- Swansea, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carlsbad, California, United States; Maitland, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States; Knoxville, Tennessee, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.