BridgeMD
New treatment option for Multiple Sclerosis
Official title A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
ClinicalTrials.gov ID: NCT07074886
What this study is testing
What is Ocrelizumab Test Formulation?
Ocrelizumab Test Formulation 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.
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 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.
- Phase 2: a mid-size study of how well it works
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 RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of...
- 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 (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...
- 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
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Carlsbad, California, United States
- Fort Collins, Colorado, United States
- Maitland, Florida, United States
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Worcester, Massachusetts, United States
- Syracuse, New York, United States
- Knoxville, Tennessee, United States
- Seattle, Washington, United States
- CABA, Buenos Aires, Argentina
- CABA, CABA / Buenos Aires, Argentina
- Rosario, Santa Fe Province, Argentina
- Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- San Miguel de Tucumán, Argentina
- Salvador, Estado de Bahia, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Curitiba, Paraná, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Joinville, Santa Catarina, Brazil
+ 30 more site(s).
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; Fort Collins, Colorado, United States; Maitland, Florida, United States; Tampa, Florida, United States; Baltimore, Maryland, United States; Worcester, Massachusetts, United States and 44 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.