Comparing a proposed biosimilar, PB018, with Ocrevus in adults with multiple sclerosis
Compares PB018 with Ocrevus for safety and body response in multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus
Key facts
- Where
- Hradec Králové, Jihlava 1, Olomouc, Teplice, and Zlin, CzechiaSee the 5 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07606521, who can take part
Where in Czechia
- Fakultni nemocnice Hradec KraloveHradec Králové, CzechiaNot yet recruiting
- Nemocnice Jihlava prispevkova organizaceJihlava 1, CzechiaNot yet recruiting
- University Hospital OlomoucOlomouc, CzechiaNot yet recruiting
- Krajska zdravotni a.s.Teplice, CzechiaNot yet recruiting
- Krajska Nemocnice T Bati a.s.Zlin, CzechiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Polpharma Biologics International AG
- Trial code
- NCT07606521EU 2026-525314-61-00
- Record updated
- 28 May 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: Patients who have received or are going to receive any of prohibited medications or treatments defined in the study protocol; 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 diagnosed with PPMS < 10 years with an EDSS at screening ≤ 5.0 or < 15 years with an EDSS at screening > 5; Patient diagnosed with RMS for more than 10 years duration with an EDSS score ≤2.0 at Screening; Patient unable to complete or has a contraindication to an MRI.