A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus
Starting soon · Phase 1
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT07606521
- Run by
- Polpharma Biologics International AG
- People needed
- 222
- Starts
- 2026-10-01
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Full record on ClinicalTrials.gov
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