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Not yet taking people in BulgariaPhase 1

Comparing a proposed biosimilar, PB018, with Ocrevus in adults with multiple sclerosis

Compares PB018 with Ocrevus for safety and body response in multiple sclerosis.

Key facts

Who runs it
Polpharma Biologics International AG
Where
Pleven, Plovdiv, Sofia, and Sofiya, BulgariaSee the 6 sitesAlso in 3 other countries, 19 sites
Trial code
Registry title
A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus
Status
Not yet recruiting
Phase
Phase 1
People taking part
222 people, planned
Started
Oct 2026
Expected to end
Apr 2028
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • US-Ocrevus
  • PB018
  • EU-Ocrevus
Record updated
28 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with relapsing or primary progressive multiple sclerosis who have had recent disease activity. It compares PB018 with Ocrevus.

Age
18 Years to 65 Years
Sex
Men and women
Disease stage
Relapsing MS (RMS) or primary progressive MS (PPMS), diagnosed by the revised McDonald criteria. Recent disease activity as defined in the study protocol. Baseline EDSS score 0 to 6.0 for RMS, 3.0 to 6.5 for PPMS.
Earlier treatment
Neurologically stable for ≥ 30 days before screening and before the first study treatment. People who have received or will receive prohibited medications or treatments defined in the study protocol cannot join.

Main reasons for not taking part

  • RMS for more than 10 years with an EDSS score ≤2.0 at screening
  • PPMS < 10 years with EDSS at screening ≤ 5.0, or < 15 years with EDSS at screening > 5
  • Cannot complete an MRI or has a contraindication to an MRI
  • Severe hypersensitivity or contraindication to corticosteroids including methylprednisolone, or to the study drug excipients
  • Current or past medical conditions described in the study protocol

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Bulgaria

Also in 3 other countries, 19 sites

  • Medical Center "Galileo" OODPleven, BulgariaNot yet recruiting
  • University Multiprofile Hospital For Active Treatment Kaspela EOODPlovdiv, BulgariaNot yet recruiting
  • Medical Center Medica 2005 EOODSofia, BulgariaNot yet recruiting
  • Acibadem City Clinic Tokuda University Hospital EADSofiya, BulgariaNot yet recruiting
  • Diagnostics And Consultation Center Convex Ltd.Sofiya, BulgariaNot yet recruiting
  • Military Medical AcademySofiya, BulgariaNot yet recruiting

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • PB018Treatment being tested

    PB018 (Ocrelizumab)

  • US-OcrevusExisting treatment, for comparison

    US-licensed Ocrevus(Ocrelizumab)

  • EU-OcrevusExisting treatment, for comparison

    EU-approved Ocrevus(Ocrelizumab)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Comparing a proposed biosimilar, PB018, with Ocrevus in adults with multiple sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07606521, who can take part
Record updated
28 May 2026