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A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
NCT07074886 · View on ClinicalTrials.gov ↗
Study 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). 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 Studied
Interventions
- DRUG Ocrelizumab Test Formulation
- DRUG Ocrelizumab Reference Formulation
Study Locations (20)
Other
- IME - Instituto Médico Especializado — Buenos Aires
- Centro de Investigacion en Enfermedades Reumaticas CIER — Ciudad Autonoma Buenos Aires
- Sanatorio del Sur S.A. — San Miguel de Tucumán
- Charite - Universitätsmedizin Berlin — Berlin
Rio Grande do Sul
- Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda — Porto Alegre
- Núcleo de Pesquisa do Rio Grande do Sul — Porto Alegre
- Instituto do Cerebro do Rio Grande do Sul — Porto Alegre
California
- Profound Research, LLC — Carlsbad
Colorado
- Advanced Neurology of Colorado, LLC — Fort Collins
Florida
- Neurology Associates PA — Maitland
Tennessee
- Hope Neurology — Knoxville
Buenos Aires
- Centro de Especialidades Neurológicas y Rehabilitación - CENyR — CABA
CABA / Buenos Aires
- Focus CECIC — CABA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2025-11-13 |
| Est. Completion | 2030-10-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07074886
The ClinicalTrials.gov registry entry for NCT07074886 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Ocrelizumab Test Formulation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07074886 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Rio Grande do Sul, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07074886 about?
NCT07074886 is a clinical study titled "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 co...
What is the current status of trial NCT07074886?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2025-11-13. Estimated completion is 2030-10-30.
What conditions does trial NCT07074886 study?
This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07074886?
The interventions under investigation include: Ocrelizumab Test Formulation (DRUG), Ocrelizumab Reference Formulation (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07074886?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07074886 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Tennessee, Buenos Aires. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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