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

Sponsor
Polpharma Biologics International AG
Study ID
NCT07606521
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • US-Ocrevus — BIOLOGICAL
    Intravenous(IV) infusion
  • PB018 — BIOLOGICAL
    Intravenous(IV) infusion
  • EU-Ocrevus — BIOLOGICAL
    Intravenous(IV) infusion

Study Details

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.

Key Dates

First listed
May 26, 2026
Start date
Oct 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PB018
    PB018 (Ocrelizumab)
  • Active Comparator: US-Ocrevus
    US-licensed Ocrevus(Ocrelizumab)
  • Active Comparator: EU-Ocrevus
    EU-approved Ocrevus(Ocrelizumab)

Primary Outcome Measure

Area under the concentration time curve [ Time Frame: Week 0 to Week 24 ]

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