Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®
NCT ID: NCT04115488
Last Updated: 2023-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
265 participants
INTERVENTIONAL
2019-10-01
2022-02-07
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PB006
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of PB006 at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions.
Intravenous (IV) infusions
Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
Tysabri
Patients with relapsing-remitting multiple sclerosis (RRMS) received intravenous (IV) infusions every 4 weeks of Tysabri at a dose of 300 milligram (mg) starting at Visit 1 (Week 0) through Visit 12 (Week 44), for a total of 12 infusions. At Week 24, patients in the Tysabri group were re-randomized through a re-randomization step. Patients re-randomized and switched from Tysabri to PB006 at Week 24 still received a total of 12 infusions (6 infusions of Tysabri and 6 infusions of PB006).
Intravenous (IV) infusions
Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
Interventions
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Intravenous (IV) infusions
Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
Eligibility Criteria
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Inclusion Criteria
* At least 1 documented relapse within the previous year and either ≥1 GdE T1-weighted brain lesions or ≥9 T2-weighted brain lesions at Screening
* Kurtzke Expanded Disability Status Scale (EDSS) score from 0 to 5 (inclusive) at Screening
Exclusion Criteria
* Relapse within the 30 days prior Screening and until administration of the first dose of 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 micromol per litre
18 Years
60 Years
ALL
No
Sponsors
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Polpharma Biologics S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Karsten Roth, Dr.
Role: STUDY_DIRECTOR
Polpharma Biologics S.A.
Locations
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Grodno Regional Clinical Hospital
Grodno, , Belarus
Minsk City Clinical Hospital #5
Minsk, , Belarus
Republican Research and Development Center for Neurology and Neurosurgery
Minsk, , Belarus
Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
Minsk, , Belarus
Vitebsk Regional Diagnostic Center
Vitebsk, , Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, , Belarus
Clinical Hospital Center Osijek, Clinic of Neurology
Osijek, , Croatia
Clinical Hospital Center Split, Clinic of Neurology
Split, , Croatia
University Hospital Centre Zagreb, Clinic of Neurology
Zagreb, , Croatia
P. Sarajishvili Institute of Neurology, LTD
Tbilisi, , Georgia
LTD Saint Michael Archangel Multifunctional Clinical Hospital
Tbilisi, , Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi, , Georgia
LTD S.Khechinashvili University Hospital
Tbilisi, , Georgia
LTD Aversi Clinic
Tbilisi, , Georgia
Pineo Medical Ecosystem
Tbilisi, , Georgia
Institute for Emergency Medicine, Department of Neurology
Chisinau, , Moldova
Institute for Emergency Medicine, Department of Neurology
Chisinau, , Moldova
National Institute of Neurology and Neurosurgery, Vascular Neurology Department
Chisinau, , Moldova
COPERNICUS Podmiot Leczniczy Sp. z o.o N. Copernicus Hospital, Department of Neurology
Gdansk, Pomeranian Voivodeship, Poland
Neuro-Medic
Katowice, , Poland
Neurology Center Krzysztof Selmaj
Lodz, , Poland
Provincial Specialist Hospital in Olsztyn, Department of Neurology
Olsztyn, , Poland
MED-Polonia, Sp. z o.o. (LLC)
Poznan, , Poland
NeuroProtect Medical Center
Warsaw, , Poland
Clinical Center of Serbia, Clinic of Neurology
Belgrade, , Serbia
Clinical Hospital Center Zemun, Department of Neurology
Belgrade, , Serbia
Clinical Center Kragujevac, Clinic of Neurology
Kragujevac, , Serbia
Clinical Center of Vojvodina, Clinic of Neurology
Novi Sad, , Serbia
Cherkasy Regional Hospital of Cherkasy Oblast Council
Cherkasy, , Ukraine
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
Dnipro, , Ukraine
Ivano-Frankivsk City Clinical Hospital #1
Ivano-Frankivsk, , Ukraine
Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
City Clinical Hospital #7
Kharkiv, , Ukraine
Institute of Neurology, Psychiatry and Narcology
Kharkiv, , Ukraine
Kharkiv Railway Clinical Hospital
Kharkiv, , Ukraine
Kyiv City Clinical Hospital
Kyiv, , Ukraine
Medical Center of First Private Clinic
Kyiv, , Ukraine
National Research Center for Radiation Medicine
Kyiv, , Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv, , Ukraine
Lviv City Clinical Hospital #5
Lviv, , Ukraine
Center for Reconstructive and Restorative Medicine (University Clinic)
Odesa, , Ukraine
Sklifosovskyi Regional Clinical Hospital
Poltava, , Ukraine
Ternopil Regional Clinical Psychonevrological Hospital
Ternopil, , Ukraine
Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
Vinnytsia, , Ukraine
Clinical Hospital No. 9 under Zaporizhia City Council
Zaporizhia, , Ukraine
City Clinical Hospital #2
Zaporizhzhya, , Ukraine
Zaporizhia Regional Clinical Hospital
Zaporizhzhya, , Ukraine
O.F. Herbachevskyi Regional Clinical Hospital
Zhytomyr, , Ukraine
Countries
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References
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Hemmer B, Wiendl H, Roth K, Wessels H, Hofler J, Hornuss C, Liedert B, Selmaj K. Efficacy and Safety of Proposed Biosimilar Natalizumab (PB006) in Patients With Relapsing-Remitting Multiple Sclerosis: The Antelope Phase 3 Randomized Clinical Trial. JAMA Neurol. 2023 Mar 1;80(3):298-307. doi: 10.1001/jamaneurol.2022.5007.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PB006-03-01
Identifier Type: -
Identifier Source: org_study_id
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