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

Last updated: June 13, 2023
Sponsor: Polpharma Biologics S.A.
Overall Status: Completed

Phase

3

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

Intravenous (IV) infusions

Clinical Study ID

NCT04115488
PB006-03-01
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients (age ≥18 to 60 years), with relapsing-remitting multiplesclerosis (RRMS) defined by the 2010 revised McDonald criteria
  • At least 1 documented relapse within the previous year and either ≥1 GdE T1-weightedbrain lesions or ≥9 T2-weighted brain lesions at Screening
  • Kurtzke Expanded Disability Status Scale (EDSS) score from 0 to 5 (inclusive) atScreening

Exclusion

Exclusion Criteria:

  • Manifestation of multiple sclerosis (MS) other than relapsing-remitting multiplesclerosis (RRMS)
  • Relapse within the 30 days prior Screening and until administration of the first doseof study drug
  • Prior treatment with natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab,cladribine, or other B- and T-cell targeting therapies
  • Prior total lymphoid irradiation or bone marrow or organ transplantation
  • Patients with John Cunningham Virus (JCV) index >1.5 at Screening
  • Past or current Progressive Multi-focal leukoencephalopathy (PML) diagnosis
  • Severe renal function impairment as defined by serum creatinine values >120 micromolper litre

Study Design

Total Participants: 265
Treatment Group(s): 1
Primary Treatment: Intravenous (IV) infusions
Phase: 3
Study Start date:
October 01, 2019
Estimated Completion Date:
February 07, 2022

Study Description

This is a Phase 3 multicenter, double-blind, active-controlled, randomized, parallel-group study to assess the equivalence in efficacy and similarity in safety of biosimilar PB006 compared to Tysabri in patients with RRMS.

All eligible patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, to receive a total of twelve intravenous (IV) infusion of either PB006 or Tysabri at a dose of 300 mg at each intravenous (IV) infusion administered with every single one intravenous (IV) infusion administered every 4 weeks of either PB006 or Tysabri at a dose of 300 mg starting at visit 1 (week 0) through visit 12 (week 44), for a total of 12 infusions. The End-of-Study Visit (visit 13, week 48) will be performed 4 weeks after the last infusion

Connect with a study center

  • Grodno Regional Clinical Hospital

    Grodno, 230017
    Belarus

    Site Not Available

  • Minsk City Clinical Hospital #5

    Minsk, 220026
    Belarus

    Site Not Available

  • Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology

    Minsk, 220116
    Belarus

    Site Not Available

  • Republican Research and Development Center for Neurology and Neurosurgery

    Minsk, 220114
    Belarus

    Site Not Available

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037
    Belarus

    Site Not Available

  • Vitebsk Regional Diagnostic Center

    Vitebsk, 210023
    Belarus

    Site Not Available

  • Clinical Hospital Center Osijek, Clinic of Neurology

    Osijek, 31000
    Croatia

    Site Not Available

  • Clinical Hospital Center Split, Clinic of Neurology

    Split, 21000
    Croatia

    Site Not Available

  • University Hospital Centre Zagreb, Clinic of Neurology

    Zagreb, 10000
    Croatia

    Site Not Available

  • LTD Aversi Clinic

    Tbilisi,
    Georgia

    Site Not Available

  • LTD S.Khechinashvili University Hospital

    Tbilisi, 0179
    Georgia

    Site Not Available

  • LTD Saint Michael Archangel Multifunctional Clinical Hospital

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

    Tbilisi, 0172
    Georgia

    Site Not Available

  • P. Sarajishvili Institute of Neurology, LTD

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Pineo Medical Ecosystem

    Tbilisi,
    Georgia

    Site Not Available

  • Institute for Emergency Medicine, Department of Neurology

    Chisinau, 2028
    Moldova, Republic of

    Site Not Available

  • National Institute of Neurology and Neurosurgery, Vascular Neurology Department

    Chisinau, 2028
    Moldova, Republic of

    Site Not Available

  • COPERNICUS Podmiot Leczniczy Sp. z o.o N. Copernicus Hospital, Department of Neurology

    Gdansk, Pomerania 80-803
    Poland

    Site Not Available

  • Neuro-Medic

    Katowice, 40-555
    Poland

    Site Not Available

  • Neurology Center Krzysztof Selmaj

    Lodz, 90-324
    Poland

    Site Not Available

  • Provincial Specialist Hospital in Olsztyn, Department of Neurology

    Olsztyn, 10-561
    Poland

    Site Not Available

  • MED-Polonia, Sp. z o.o. (LLC)

    Poznan,
    Poland

    Site Not Available

  • NeuroProtect Medical Center

    Warszawa, 01-684
    Poland

    Site Not Available

  • Clinical Center of Serbia, Clinic of Neurology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center Zemun, Department of Neurology

    Belgrade, 11080
    Serbia

    Site Not Available

  • Clinical Center Kragujevac, Clinic of Neurology

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Clinical Center of Vojvodina, Clinic of Neurology

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Cherkasy Regional Hospital of Cherkasy Oblast Council

    Cherkasy,
    Ukraine

    Site Not Available

  • Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital

    Dnipro,
    Ukraine

    Site Not Available

  • Ivano-Frankivsk City Clinical Hospital #1

    Ivano-Frankivs'k,
    Ukraine

    Site Not Available

  • Regional Clinical Hospital

    Ivano-Frankivs'k,
    Ukraine

    Site Not Available

  • City Clinical Hospital #7

    Kharkiv,
    Ukraine

    Site Not Available

  • Institute of Neurology, Psychiatry and Narcology

    Kharkiv,
    Ukraine

    Site Not Available

  • Kharkiv Railway Clinical Hospital

    Kharkiv,
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital

    Kyiv,
    Ukraine

    Site Not Available

  • Medical Center of First Private Clinic

    Kyiv,
    Ukraine

    Site Not Available

  • National Research Center for Radiation Medicine

    Kyiv,
    Ukraine

    Site Not Available

  • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

    Lviv,
    Ukraine

    Site Not Available

  • Lviv City Clinical Hospital #5

    Lviv,
    Ukraine

    Site Not Available

  • Center for Reconstructive and Restorative Medicine (University Clinic)

    Odesa,
    Ukraine

    Site Not Available

  • Sklifosovskyi Regional Clinical Hospital

    Poltava,
    Ukraine

    Site Not Available

  • Ternopil Regional Clinical Psychonevrological Hospital

    Ternopil',
    Ukraine

    Site Not Available

  • Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital

    Vinnytsia,
    Ukraine

    Site Not Available

  • Clinical Hospital No. 9 under Zaporizhia City Council

    Zaporizhia,
    Ukraine

    Site Not Available

  • City Clinical Hospital #2

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • Zaporizhia Regional Clinical Hospital

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • O.F. Herbachevskyi Regional Clinical Hospital

    Zhytomyr, 10008
    Ukraine

    Site Not Available

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