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
- Diseases
- Multiple sclerosis
- 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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center "Galileo" OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Not yet recruiting |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Not yet recruiting |
| Medical Center Medica 2005 EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Not yet recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Military Medical Academy Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Not yet recruiting |
| Nemocnice Jihlava prispevkova organizace Coordinator of this site? Confirm its status | Jihlava 1 | Czechia | Not yet recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Not yet recruiting |
| Krajska zdravotni a.s. Coordinator of this site? Confirm its status | Teplice | Czechia | Not yet recruiting |
| Krajska Nemocnice T Bati a.s. Coordinator of this site? Confirm its status | Zlin | Czechia | Not yet recruiting |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Not yet recruiting |
| University Hospital Sveti Duh Coordinator of this site? Confirm its status | Zagreb | Croatia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.