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Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®

NCT04115488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2023-07-03

Study results available
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Summary

This is a multi-center, randomized, parallel arm, double-blind study with a total duration of subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed Natalizumab.

Conditions

  • Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

BIOLOGICAL

Intravenous (IV) infusions

Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses

Sponsors & Collaborators

  • Polpharma Biologics S.A.

    lead INDUSTRY

Principal Investigators

  • Karsten Roth, Dr. · Polpharma Biologics S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-08-23
Completion
2022-02-07
FDA Drug
Yes

Countries

  • Belarus
  • Croatia
  • Georgia
  • Moldova
  • Poland
  • Serbia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115488 on ClinicalTrials.gov