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Multiple SclerosisPhase 1NCT07606521

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

A Phase 1 study testing US-Ocrevus, PB018 and EU-Ocrevus in people with Multiple Sclerosis, run by Polpharma Biologics International AG.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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 more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
US-Ocrevus, PB018 and EU-Ocrevus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
No sites listed yet
Study dates
Oct 2026to Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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.

About this study

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)

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 the detailed description

PB018, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus. The purpose of this study is to demonstrate similar PK, PD and safety of PB018 and Ocrevus in patients with Multiple Sclerosis.

Being tested
US-Ocrevus, PB018, EU-Ocrevus
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • US-OcrevusBiological

    Intravenous(IV) infusion

  • PB018Biological

    Intravenous(IV) infusion

  • EU-OcrevusBiological

    Intravenous(IV) infusion

Study groups in NCT07606521
Study groupRoleWhat they receive
PB018ExperimentalPB018 (Ocrelizumab)
Receives: Biological: PB018
US-OcrevusActive comparatorUS-licensed Ocrevus(Ocrelizumab)
Receives: Biological: US-Ocrevus
EU-OcrevusActive comparatorEU-approved Ocrevus(Ocrelizumab)
Receives: Biological: EU-Ocrevus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration time curve

    Demonstrate similar PK between Ocrevus and PB018

    Measured: Week 0 to Week 24

Secondary outcomes (19)

  1. Time to reach Maximum serum concentration (Cmax)

    Measured: Week 0 and Week 2

  2. Area under the concentration time curve in participants treated with PB018 versus US-licensed Ocrevus

    Measured: Week 0 to Week 16

  3. Area under the concentration time curve in participants treated with PB018 versus EU-approved Ocrevus

    Measured: Week 0 to Week 16

  4. Tmax (W0)

    Measured: Week 0

  5. Tmax (W2)

    Measured: Week 2

  6. T1/2

    Measured: Week 0 to Week 24

  7. Clearance

    Measured: Week 0 to Week 24

  8. Elimination rate constant

    Measured: Week 0 to Week 24

  9. Volume of Distribution (Vz)

    Measured: Week 0 to Week 24

  10. Ctrough

    Measured: Week 0 to Week 24

  11. Mean residence time (MRT)

    Measured: Week 0 to Week 24

  12. B-cell Depletion (CD19+ Cells)

    Assessment of pharmacodynamic similarity between PB018 and reference ocrelizumab products based on the proportion of participants with CD19+ B-cell counts below predefined thresholds.

    Measured: Week 0 to Week 24

  13. MRI Lesion Activity

    Assessment of similarity in MRI disease activity between PB018 and reference ocrelizumab products by evaluating new or enlarging brain lesions.

    Measured: Week 0; Week 12; Week 24

  14. Expanded Disability Status Scale (EDSS) score

    Use of Disability Status Scale to measure for disability progression.

    Measured: Screening to Week 24

  15. Total number of participants with positive anti-drug antibodies (ADAs)

    Measured: Week 0 to Week 24

  16. Total number of participants with neutralizing antibodies (Nab)

    Measured: Week 0 to Week 24

  17. Number of participants with treatment-emergent adverse events (TEAE) as assessed by CTCAE v6.0

    Measured: Week 0 to Week 24

  18. Number of participants discontinued due to adverse events / serious adverse events as assessed by CTCAE v6.0

    Measured: Week 0 to Week 24

  19. Number of participants with treatment-emergent adverse events of special interest (TEAESI) as assessed by CTCAE v6.0

    Measured: Week 0 to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606521
Sponsor's protocol ID
PB018-01-01
Status last verified
May 2026
First submitted
11 May 2026
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing US-Ocrevus, PB018 and EU-Ocrevus in people with Multiple Sclerosis, run by Polpharma Biologics International AG.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration time curve (time frame: Week 0 to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07606521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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