A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-
A Randomized, Parallel-Group Double-Blind, Biosimilar Trial to Compare Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of PB018 Versus Ocrevus® in Participants With Multiple Sclerosis (MS)
What it found
No result yet.
What was tested
Treatment tested
- PB018
Compared with
- US-Ocrevus
- EU-Ocrevus
What it measured
Main measures
Area under the concentration time curve
Week 0 to Week 24
How the body handles the medicine
Other measures (19)
Time to reach Maximum serum concentration (Cmax)
Week 0 and Week 2
How the body handles the medicineArea under the concentration time curve in participants treated with PB018 versus US-licensed Ocrevus
Week 0 to Week 16
Area under the concentration time curve in participants treated with PB018 versus EU-approved Ocrevus
Week 0 to Week 16
Tmax (W0)
Week 0
Tmax (W2)
Week 2
T1/2
Week 0 to Week 24
MRI lesionsClearance
Week 0 to Week 24
How the body handles the medicineElimination rate constant
Week 0 to Week 24
Volume of Distribution (Vz)
Week 0 to Week 24
Ctrough
Week 0 to Week 24
How the body handles the medicine
Who could take part
Relapsing and progressive · 18 to 65 · EDSS 0 to 6.0
Show the full criteria
Inclusion criteria
* Male or female participants diagnosed with RMS and PPMS forms of MS in accordance with the revised McDonald criteria * Evidence of recent disease activity as defined in study protocol * Neurological stability for ≥ 30 days before both screening and first study treatment * Baseline EDSS score between 0 to 6.0 (both inclusive) for RMS patients and between 3.0 and 6.5 (both inclusive) for PPMS patients. Key Exclusion Criteria: * Patient diagnosed with RMS for more than 10 years duration with an EDSS score ≤2.0 at Screening * Patients diagnosed with PPMS \< 10 years with an EDSS at screening ≤ 5.0 or \< 15 years with an EDSS at screening > 5 * Patient unable to complete or has a contraindication to an MRI * Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or interventions defined in the study protocol. * Patient who has currently or history of any of medical conditions described in the study protocol. * Patients who have received or are going to receive any of prohibited medications or treatments defined in the study protocol.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
This is a randomized, parallel group, double-blind, active-controlled, clinical pharmacology study to compare Pharmacokinetics, Pharmacodynamics and safety of PB018 versus Ocrevus in patients with Multiple Sclerosis.
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History
Started
Oct 2026
Main results due
Dec 2027
Finished
Apr 2028