Bioequivalence Study of Ocrelizumab Test and Reference Formulations in Human Patients with MS
This Phase II study is designed to compare the bioequivalence of two subcutaneous formulations of ocrelizumab in patients with multiple sclerosis, specifically relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).
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- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
Determining bioequivalence is important for ensuring that new formulations of drugs provide the same efficacy and safety profile as existing ones. This can lead to more accessible treatment options for MS patients.
What this does not prove
Results have not yet been posted, and as such, the planned enrollment and endpoints are not findings themselves, limiting understanding of the study's outcomes.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (7)
study phaseA Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis
subjects"briefSummary": "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).
interventionThereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.",
comparator"description": "Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase.
primary endpoint"measure": "Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab",
findings"briefSummary": "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).
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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