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

25. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

222

Fase

  • Fase 1

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: US-Ocrevus
USA-lisensiert Ocrevus (Ocrelizumab)
Intravenøs (IV) infusjon
Aktiv komparator: EU-Ocrevus
EU-godkjent Ocrevus (Ocrelizumab)
Intravenøs (IV) infusjon
Eksperimentell: PB018
PB018 (Ocrelizumab)
Intravenous(IV) infusion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere