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A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus

Not Yet RecruitingPhase 1

Sponsor: Polpharma Biologics International AG

Conditions: Multiple Sclerosis

Interventions: US-Ocrevus, PB018, EU-Ocrevus

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.