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New MS biosimilar PB018 faces first human test against ocrevus

NCT ID NCT07606521

Disease control Sponsor: Polpharma Biologics International AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 1 trial will test PB018, a biosimilar to the MS drug Ocrevus, in 222 people with multiple sclerosis. The study compares how the body processes PB018 versus Ocrevus and checks for safety. Participants will receive either PB018 or Ocrevus, but neither they nor their doctors will know which one. The goal is to see if PB018 behaves similarly in the body, which could lead to a more affordable treatment option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PB018 (a biosimilar to ocrelizumab)
What this could lead to
If successful, PB018 could offer a more affordable treatment option for multiple sclerosis, similar to Ocrevus.
What could go wrong
This is an early Phase 1 trial focused on drug levels and safety, not on effectiveness. The biosimilar may not work as well or have different side effects than Ocrevus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 222 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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