- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07606521
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
Forhold
Intervensjon / Behandling
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PB018-01-01
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
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