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NCT07606521Not yet recruitingPhase 1

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

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)

Source: ClinicalTrials.gov · Last updated 28 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
222 (estimated)
First submitted
11 May 2026
Start date
Oct 2026
Primary completion date
Dec 2027
Lead sponsor
Polpharma Biologics International AG
NCT number
NCT07606521
EU CT number
2026-525314-61-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 222
  • From Oct 2026 to the primary completion date, Dec 2027
  • 13 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received or are going to receive any of prohibited medications or treatments defined in the study protocol.

Other illness

  • 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.

Age

  • Patients diagnosed with PPMS \< 10 years with an EDSS at screening ≤ 5.0 or \< 15 years with an EDSS at screening \> 5

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Center "Galileo" OOD
Coordinator of this site? Confirm its status
PlevenBulgariaNot yet recruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaNot yet recruiting
Medical Center Medica 2005 EOOD
Coordinator of this site? Confirm its status
SofiaBulgariaNot yet recruiting
Acibadem City Clinic Tokuda University Hospital EAD
Coordinator of this site? Confirm its status
SofiyaBulgariaNot yet recruiting
Military Medical Academy
Coordinator of this site? Confirm its status
SofiyaBulgariaNot yet recruiting
Diagnostics And Consultation Center Convex Ltd.
Coordinator of this site? Confirm its status
SofiyaBulgariaNot yet recruiting
Fakultni nemocnice Hradec Kralove
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaNot yet recruiting
Nemocnice Jihlava prispevkova organizace
Coordinator of this site? Confirm its status
Jihlava 1CzechiaNot yet recruiting
University Hospital Olomouc
Coordinator of this site? Confirm its status
OlomoucCzechiaNot yet recruiting
Krajska zdravotni a.s.
Coordinator of this site? Confirm its status
TepliceCzechiaNot yet recruiting
Krajska Nemocnice T Bati a.s.
Coordinator of this site? Confirm its status
ZlinCzechiaNot yet recruiting
University Hospital Centre Zagreb
Coordinator of this site? Confirm its status
ZagrebCroatiaNot yet recruiting
University Hospital Sveti Duh
Coordinator of this site? Confirm its status
ZagrebCroatiaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.