- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07606521
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
Intervention / Behandling
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PB018-01-01
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ja
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Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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