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

NCT07606521
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Phase
Phase 1
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Recruitment status
Not yet recruiting
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Participants
222
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Lead sponsor
Polpharma Biologics International AG
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Start date
2026-10-01
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Summary
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.
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Short title
A Biosimilar Trial to Investigate PK, PD, Safety With PB018 Versus US-licensed Ocrevus and EU-approved Ocrevus
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Official title
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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-04-01
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First posted
2026-05-26
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Registry last updated
2026-05-28
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Primary completion date
2027-12-01
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Start date
2026-10-01
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Participants
222
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Participant count basis
Estimated
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Planned participants
222
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Protocol amendments
0
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Registry sponsor category
Industry
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Lead sponsor
Polpharma Biologics International AG
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07606521
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ClinicalTrials.gov ID
NCT07606521
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Area under the concentration time curve

    Timeframe: Week 0 to Week 24

    Demonstrate similar PK between Ocrevus and PB018

  1. Time to reach Maximum serum concentration (Cmax)

    Timeframe: Week 0 and Week 2

  2. Area under the concentration time curve in participants treated with PB018 versus US-licensed Ocrevus

    Timeframe: Week 0 to Week 16

  3. Area under the concentration time curve in participants treated with PB018 versus EU-approved Ocrevus

    Timeframe: Week 0 to Week 16

  4. Tmax (W0)

    Timeframe: Week 0

  5. Tmax (W2)

    Timeframe: Week 2

  6. T1/2

    Timeframe: Week 0 to Week 24

  7. Clearance

    Timeframe: Week 0 to Week 24

  8. Elimination rate constant

    Timeframe: Week 0 to Week 24

  9. Volume of Distribution (Vz)

    Timeframe: Week 0 to Week 24

  10. Ctrough

    Timeframe: Week 0 to Week 24

  11. Mean residence time (MRT)

    Timeframe: Week 0 to Week 24

  12. B-cell Depletion (CD19+ Cells)

    Timeframe: 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.

  13. MRI Lesion Activity

    Timeframe: 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.

  14. Expanded Disability Status Scale (EDSS) score

    Timeframe: Screening to Week 24

    Use of Disability Status Scale to measure for disability progression.

  15. Total number of participants with positive anti-drug antibodies (ADAs)

    Timeframe: Week 0 to Week 24

  16. Total number of participants with neutralizing antibodies (Nab)

    Timeframe: Week 0 to Week 24

  17. Number of participants with treatment-emergent adverse events (TEAE) as assessed by CTCAE v6.0

    Timeframe: Week 0 to Week 24

  18. Number of participants discontinued due to adverse events / serious adverse events as assessed by CTCAE v6.0

    Timeframe: Week 0 to Week 24

  19. Number of participants with treatment-emergent adverse events of special interest (TEAESI) as assessed by CTCAE v6.0

    Timeframe: Week 0 to Week 24

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  • 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.
Sources for eligibility
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)