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

25. maj 2026 opdateret af: Polpharma Biologics International AG

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

222

Fase

  • Fase 1

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: US-Ocrevus
USA-licenseret Ocrevus (Ocrelizumab)
Intravenøs (IV) infusion
Aktiv komparator: EU-Ocrevus
EU-godkendt Ocrevus (Ocrelizumab)
Intravenøs (IV) infusion
Eksperimentel: PB018
PB018 (Ocrelizumab)
Intravenous(IV) infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under the concentration time curve
Tidsramme: Week 0 to Week 24
Demonstrate similar PK between Ocrevus and PB018
Week 0 to Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to reach Maximum serum concentration (Cmax)
Tidsramme: Week 0 and Week 2
Week 0 and Week 2
Area under the concentration time curve in participants treated with PB018 versus US-licensed Ocrevus
Tidsramme: Week 0 to Week 16
Week 0 to Week 16
Area under the concentration time curve in participants treated with PB018 versus EU-approved Ocrevus
Tidsramme: Week 0 to Week 16
Week 0 to Week 16
Tmax (W0)
Tidsramme: Week 0
Week 0
Tmax (W2)
Tidsramme: Week 2
Week 2
T1/2
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Clearance
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Elimination rate constant
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Volume of Distribution (Vz)
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Ctrough
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Mean residence time (MRT)
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
B-cell Depletion (CD19+ Cells)
Tidsramme: Week 0 to Week 24
Assessment of pharmacodynamic similarity between PB018 and reference ocrelizumab products based on the proportion of participants with CD19+ B-cell counts below predefined thresholds.
Week 0 to Week 24
MRI Lesion Activity
Tidsramme: Week 0; Week 12; Week 24
Assessment of similarity in MRI disease activity between PB018 and reference ocrelizumab products by evaluating new or enlarging brain lesions.
Week 0; Week 12; Week 24
Expanded Disability Status Scale (EDSS) score
Tidsramme: Screening to Week 24
Use of Disability Status Scale to measure for disability progression.
Screening to Week 24
Total number of participants with positive anti-drug antibodies (ADAs)
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Total number of participants with neutralizing antibodies (Nab)
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Number of participants with treatment-emergent adverse events (TEAE) as assessed by CTCAE v6.0
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Number of participants discontinued due to adverse events / serious adverse events as assessed by CTCAE v6.0
Tidsramme: Week 0 to Week 24
Week 0 to Week 24
Number of participants with treatment-emergent adverse events of special interest (TEAESI) as assessed by CTCAE v6.0
Tidsramme: Week 0 to Week 24
Week 0 to Week 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

26. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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