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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis (RRMS)

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Intravenous (IV) infusions

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis (RRMS)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients (age ≥18 to 60 years), with relapsing-remitting multiple sclerosis (RRMS) defined by the 2010 revised McDonald 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:

Manifestation of multiple sclerosis (MS) other than relapsing-remitting multiple sclerosis (RRMS)
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-fokal Leukencephalopathy (PML) diagnosis
Severe renal function impairment as defined by serum creatinine values >120 micromol per litre

Sites / Locations

Grodno Regional Clinical Hospital
Minsk City Clinical Hospital #5
Republican Research and Development Center for Neurology and Neurosurgery
Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
Vitebsk Regional Diagnostic Center
Vitebsk Regional Clinical Hospital
Clinical Hospital Center Osijek, Clinic of Neurology
Clinical Hospital Center Split, Clinic of Neurology
University Hospital Centre Zagreb, Clinic of Neurology
P. Sarajishvili Institute of Neurology, LTD
LTD Saint Michael Archangel Multifunctional Clinical Hospital
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
LTD S.Khechinashvili University Hospital
LTD Aversi Clinic
Pineo Medical Ecosystem
Institute for Emergency Medicine, Department of Neurology
Institute for Emergency Medicine, Department of Neurology
National Institute of Neurology and Neurosurgery, Vascular Neurology Department
COPERNICUS Podmiot Leczniczy Sp. z o.o N. Copernicus Hospital, Department of Neurology
Neuro-Medic
Neurology Center Krzysztof Selmaj
Provincial Specialist Hospital in Olsztyn, Department of Neurology
MED-Polonia, Sp. z o.o. (LLC)
NeuroProtect Medical Center
Clinical Center of Serbia, Clinic of Neurology
Clinical Hospital Center Zemun, Department of Neurology
Clinical Center Kragujevac, Clinic of Neurology
Clinical Center of Vojvodina, Clinic of Neurology
Cherkasy Regional Hospital of Cherkasy Oblast Council
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
Ivano-Frankivsk City Clinical Hospital #1
Regional Clinical Hospital
City Clinical Hospital #7
Institute of Neurology, Psychiatry and Narcology
Kharkiv Railway Clinical Hospital
Kyiv City Clinical Hospital
Medical Center of First Private Clinic
National Research Center for Radiation Medicine
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv City Clinical Hospital #5
Center for Reconstructive and Restorative Medicine (University Clinic)
Sklifosovskyi Regional Clinical Hospital
Ternopil Regional Clinical Psychonevrological Hospital
Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
Clinical Hospital No. 9 under Zaporizhia City Council
City Clinical Hospital #2
Zaporizhia Regional Clinical Hospital
O.F. Herbachevskyi Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PB006

Tysabri

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Cumulative Number of New Active Lesions Over 24 Weeks

Cumulative number of new active lesions over 24 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted and new/enlarging T2-weighted lesion. Assessment was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.

Secondary Outcome Measures

Cumulative Number of New Active Lesions Over 48 Weeks

Cumulative number of new active lesions over 48 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted and new/enlarging T2-weighted lesion. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent was administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].

Cumulative Number of New GdE T1-weighted Lesions Over 24 Weeks

Cumulative number of new GdE T1-weighted lesions over 24 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].

Cumulative Number of New GdE T1-weighted Lesions Over 48 Weeks

Cumulative number of new GdE T1-weighted lesions over 48 weeks, calculated as the sum of all new gadolinium-enhancing (GdE) T1-weighted. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].

Number of Patients Without New GdE T1-weighted Lesions Over 24 Weeks

Number of patients without new GdE T1-weighted lesions over 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].

Number of Patients Without New GdE T1-weighted Lesions Over 48 Weeks

Number of patients without new GdE T1-weighted lesions over 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].

Cumulative Number of New/Enlarging T2-weighted Lesions Over 24 Weeks

Cumulative number of new/enlarging T2-weighted lesions over 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.

Cumulative Number of New/Enlarging T2-weighted Lesions Over 48 Weeks

Cumulative number of new/enlarging T2-weighted lesions over 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.

Number of Persistent Lesions After 24 Weeks

Number of persistent lesions after 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].

Number of Persistent Lesions After 48 Weeks

Number of persistent lesions after 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of GdE T1-weighted lesions and T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center. A macrocyclic Gd-based contrast agent (gadobutrol, gadoteric acid, or gadoteridol) was to be administered as an Intravenous infusion of 0.1 Millimole per kilogram [mmol/kg].

Annualized Relapse Rate After 24 Weeks

Annualized relapse rate after 24 weeks. Relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality had to be present for at least 24 hours and have occurred in the absence of fever or infection. Annualized relapse rate: A: Number of medically confirmed relapses overall. B: Duration of follow-up time overall, where follow-up time was defined as: (last day of follow-up - day of randomization + 1) / 365.25. The ratio of relapses per patient-year: A/B. Annualized Relapse Rate was calculated across the entire group.

Annualized Relapse Rate After 48 Weeks

Annualized relapse rate after 48 weeks. Relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality had to be present for at least 24 hours and have occurred in the absence of fever or infection. Annualized relapse rate: A: Number of medically confirmed relapses overall. B: Duration of follow-up time overall, where follow-up time was defined as: (last day of follow-up - day of randomization + 1) / 365.25. The ratio of relapses per patient-year: A/B. Annualized Relapse Rate was calculated across the entire group.

Change From Baseline in Expanded Disability Status Scale (EDSS) After 24 Weeks

Change from baseline in Expanded Disability Status Scale (EDSS) after 24 weeks. The Kurtzke EDSS, commonly used to evaluate the degree of neurologic impairment in multiple sclerosis (MS), is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. Based on a standard neurological examination, the 7 functional systems (plus "other") are rated. These ratings are then used in conjunction with observations and information concerning gait and use of assistive devices to rate the EDSS. EDSS ratings were performed by independent examining neurologists. After re-randomization, Week 24 is considered baseline.

Change From Baseline in Expanded Disability Status Scale (EDSS) After 48 Weeks

Change from baseline in Expanded Disability Status Scale (EDSS) after 48 weeks. The Kurtzke EDSS, commonly used to evaluate the degree of neurologic impairment in MS, is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. Based on a standard neurological examination, the 7 functional systems (plus "other") are rated. These ratings are then used in conjunction with observations and information concerning gait and use of assistive devices to rate the EDSS. EDSS ratings were performed by independent examining neurologists.

Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 24 Weeks

Percentage of subjects with anti-drug (natalizumab) antibodies (ADA) and persistent antibodies after 24 weeks. A positive ADA patient was defined as a patient who had at least 1 positive ADA result in any post-baseline sample. A persistently positive ADA patient was defined as a patient with confirmed positive ADAs in 2 or more consecutive positive ADA samples at post-dose visits.

Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 48 Weeks

Percentage of subjects with anti-drug (natalizumab) antibodies (ADA) and persistent antibodies after 48 weeks. A positive ADA patient was defined as a patient who had at least 1 positive ADA result in any post-baseline sample. A persistently positive ADA patient was defined as a patient with confirmed positive ADAs in 2 or more consecutive positive ADA samples at post-dose visits.

Percentage of Subjects With Neutralizing Antibodies After 24 Weeks

Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 24 weeks.

Percentage of Subjects With Neutralizing Antibodies After 48 Weeks

Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 48 weeks.

Number of Subjects With Any Treatment-Emergent Adverse Event (TEAE) or Any Treatment-Emergent Serious Adverse Event (SAE) After 24 Weeks

Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 24 weeks.

Number of Subjects With Any Treatment-Emergent Adverse Event (TEAE) or Any Treatment-Emergent Serious Adverse Event (SAE) After 48 Weeks

Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 48 weeks.

Natalizumab Trough Concentration (Ctrough) Over Time, Week 8

Natalizumab trough concentration (Ctrough) over time, week 8. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Natalizumab Trough Concentration (Ctrough) Over Time, Week 16

Natalizumab trough concentration (Ctrough) over time, week 16. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Natalizumab Trough Concentration (Ctrough) Over Time, Week 24

Natalizumab trough concentration (Ctrough) over time, week 24. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Natalizumab Trough Concentration (Ctrough) Over Time, Week 32

Natalizumab trough concentration (Ctrough) over time, week 32. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Natalizumab Trough Concentration (Ctrough) Over Time, Week 48

Natalizumab trough concentration (Ctrough) over time, week 48. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Number of Patients Without New/Enlarging T2-weighted Lesions Over 24 Weeks

Number of patients without new/enlarging T2-weighted lesions over 24 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.

Number of Patients Without New/Enlarging T2-weighted Lesions Over 48 Weeks

Number of patients without new/enlarging T2-weighted lesions over 48 weeks. Assessment of lesions was performed using Magnetic Resonance Imaging (MRI). Identification of T2-weighted lesions was done by a trained and certified radiology reviewer according to standard procedures at the MRI central reading center.

Number of Patients With Abnormal Clinical Laboratory Tests at Week 24

Number of patients with abnormal clinical laboratory tests at week 24.

Number of Patients With Abnormal Clinical Laboratory Tests at Week 48

Number of patients with abnormal clinical laboratory tests at week 48.

Number of Patients With Abnormal Findings in Physical Examination at Week 24

Number of patients with abnormal findings in physical examination at week 24.

Number of Patients With Abnormal Findings in Physical Examination at Week 48

Number of patients with abnormal findings in physical examination at week 48.

Change From Baseline in Blood Pressure at Week 24

Change from baseline in diastolic and systolic blood Pressure at week 24.

Change From Baseline in Blood Pressure at Week 48

Change from baseline in diastolic and systolic blood Pressure at week 48.

Change From Baseline in Heart Rate at Week 24

Change from baseline in heart rate at week 24.

Change From Baseline in Heart Rate at Week 48

Change from baseline in heart rate at week 48.

Full Information

NCT ID

NCT04115488

First Posted

September 10, 2019

Last Updated

June 13, 2023

Sponsor

Polpharma Biologics S.A.

1. Study Identification

Unique Protocol Identification Number

NCT04115488

Brief Title

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

Acronym

Antelope

Official Title

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

August 23, 2021 (Actual)

Study Completion Date

February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polpharma Biologics S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing-Remitting Multiple Sclerosis (RRMS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PB006

Arm Type

Experimental

Arm Description

Arm Title

Tysabri

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Intravenous (IV) infusions

Intervention Description

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

Primary Outcome Measure Information:

Title

Cumulative Number of New Active Lesions Over 24 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20 and 24.

Secondary Outcome Measure Information:

Title

Cumulative Number of New Active Lesions Over 48 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.

Title

Cumulative Number of New GdE T1-weighted Lesions Over 24 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20 and 24.

Title

Cumulative Number of New GdE T1-weighted Lesions Over 48 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.

Title

Number of Patients Without New GdE T1-weighted Lesions Over 24 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20 and 24.

Title

Number of Patients Without New GdE T1-weighted Lesions Over 48 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.

Title

Cumulative Number of New/Enlarging T2-weighted Lesions Over 24 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20 and 24.

Title

Cumulative Number of New/Enlarging T2-weighted Lesions Over 48 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.

Title

Number of Persistent Lesions After 24 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20 and 24.

Title

Number of Persistent Lesions After 48 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.

Title

Annualized Relapse Rate After 24 Weeks

Description

Time Frame

Up to 24 weeks.

Title

Annualized Relapse Rate After 48 Weeks

Description

Time Frame

Up to 48 weeks.

Title

Change From Baseline in Expanded Disability Status Scale (EDSS) After 24 Weeks

Description

Time Frame

Baseline and week 24.

Title

Change From Baseline in Expanded Disability Status Scale (EDSS) After 48 Weeks

Description

Time Frame

FAS: Baseline (week 0) and week 48. SSW: Baseline (week 24) and week 48.

Title

Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 24 Weeks

Description

Time Frame

Up to 24 weeks.

Title

Percentage of Subjects With Anti-drug (Natalizumab) Antibodies (ADA) and Persistent Antibodies After 48 Weeks

Description

Time Frame

Up to 48 weeks.

Title

Percentage of Subjects With Neutralizing Antibodies After 24 Weeks

Description

Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 24 weeks.

Time Frame

Up to 24 weeks.

Title

Percentage of Subjects With Neutralizing Antibodies After 48 Weeks

Description

Percentage of subjects with positive (transient and persistent) neutralizing antibodies after 48 weeks.

Time Frame

Up to 48 weeks.

Title

Number of Subjects With Any Treatment-Emergent Adverse Event (TEAE) or Any Treatment-Emergent Serious Adverse Event (SAE) After 24 Weeks

Description

Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 24 weeks.

Time Frame

Up to week 24

Title

Number of Subjects With Any Treatment-Emergent Adverse Event (TEAE) or Any Treatment-Emergent Serious Adverse Event (SAE) After 48 Weeks

Description

Number of subjects with any Treatment-Emergent Adverse Event (TEAE) or any Treatment-Emergent Serious Adverse Event (SAE) after 48 weeks.

Time Frame

Up to 48 weeks.

Title

Natalizumab Trough Concentration (Ctrough) Over Time, Week 8

Description

Natalizumab trough concentration (Ctrough) over time, week 8. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Time Frame

Week 8

Title

Natalizumab Trough Concentration (Ctrough) Over Time, Week 16

Description

Natalizumab trough concentration (Ctrough) over time, week 16. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Time Frame

Week 16

Title

Natalizumab Trough Concentration (Ctrough) Over Time, Week 24

Description

Natalizumab trough concentration (Ctrough) over time, week 24. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Time Frame

Week 24

Title

Natalizumab Trough Concentration (Ctrough) Over Time, Week 32

Description

Natalizumab trough concentration (Ctrough) over time, week 32. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Time Frame

Week 32

Title

Natalizumab Trough Concentration (Ctrough) Over Time, Week 48

Description

Natalizumab trough concentration (Ctrough) over time, week 48. Serum samples were collected prior to treatment. Sample was taken prior to treatment for each patient.

Time Frame

Week 48

Title

Number of Patients Without New/Enlarging T2-weighted Lesions Over 24 Weeks

Description

Time Frame

Week 0 (baseline), week 8, 16, 20 and 24.

Title

Number of Patients Without New/Enlarging T2-weighted Lesions Over 48 Weeks

Description

Time Frame

Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.

Title

Number of Patients With Abnormal Clinical Laboratory Tests at Week 24

Description

Number of patients with abnormal clinical laboratory tests at week 24.

Time Frame

At week 24.

Title

Number of Patients With Abnormal Clinical Laboratory Tests at Week 48

Description

Number of patients with abnormal clinical laboratory tests at week 48.

Time Frame

At week 48.

Title

Number of Patients With Abnormal Findings in Physical Examination at Week 24

Description

Number of patients with abnormal findings in physical examination at week 24.

Time Frame

Week 24.

Title

Number of Patients With Abnormal Findings in Physical Examination at Week 48

Description

Number of patients with abnormal findings in physical examination at week 48.

Time Frame

End of study (week 48).

Title

Change From Baseline in Blood Pressure at Week 24

Description

Change from baseline in diastolic and systolic blood Pressure at week 24.

Time Frame

At baseline and week 24.

Title

Change From Baseline in Blood Pressure at Week 48

Description

Change from baseline in diastolic and systolic blood Pressure at week 48.

Time Frame

At baseline and end of study (week 48).

Title

Change From Baseline in Heart Rate at Week 24

Description

Change from baseline in heart rate at week 24.

Time Frame

At baseline and week 24.

Title

Change From Baseline in Heart Rate at Week 48

Description

Change from baseline in heart rate at week 48.

Time Frame

At baseline and end of study (week 48).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients (age ≥18 to 60 years), with relapsing-remitting multiple sclerosis (RRMS) defined by the 2010 revised McDonald 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: Manifestation of multiple sclerosis (MS) other than relapsing-remitting multiple sclerosis (RRMS) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karsten Roth, Dr.

Organizational Affiliation

Polpharma Biologics S.A.

Official's Role

Study Director

Facility Information:

Facility Name

Grodno Regional Clinical Hospital

City

Grodno

ZIP/Postal Code

230017

Country

Belarus

Facility Name

Minsk City Clinical Hospital #5

City

Minsk

ZIP/Postal Code

220026

Country

Belarus

Facility Name

Republican Research and Development Center for Neurology and Neurosurgery

City

Minsk

ZIP/Postal Code

220114

Country

Belarus

Facility Name

Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology

City

Minsk

ZIP/Postal Code

220116

Country

Belarus

Facility Name

Vitebsk Regional Diagnostic Center

City

Vitebsk

ZIP/Postal Code

210023

Country

Belarus

Facility Name

Vitebsk Regional Clinical Hospital

City

Vitebsk

ZIP/Postal Code

210037

Country

Belarus

Facility Name

Clinical Hospital Center Osijek, Clinic of Neurology

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

Clinical Hospital Center Split, Clinic of Neurology

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

University Hospital Centre Zagreb, Clinic of Neurology

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

P. Sarajishvili Institute of Neurology, LTD

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

LTD Saint Michael Archangel Multifunctional Clinical Hospital

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

City

Tbilisi

ZIP/Postal Code

0172

Country

Georgia

Facility Name

LTD S.Khechinashvili University Hospital

City

Tbilisi

ZIP/Postal Code

0179

Country

Georgia

Facility Name

LTD Aversi Clinic

City

Tbilisi

Country

Georgia

Facility Name

Pineo Medical Ecosystem

City

Tbilisi

Country

Georgia

Facility Name

Institute for Emergency Medicine, Department of Neurology

City

Chisinau

ZIP/Postal Code

2004

Country

Moldova, Republic of

Facility Name

Institute for Emergency Medicine, Department of Neurology

City

Chisinau

ZIP/Postal Code

2028

Country

Moldova, Republic of

Facility Name

National Institute of Neurology and Neurosurgery, Vascular Neurology Department

City

Chisinau

ZIP/Postal Code

2028

Country

Moldova, Republic of

Facility Name

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

City

Gdansk

State/Province

Pomerania

ZIP/Postal Code

80-803

Country

Poland

Facility Name

Neuro-Medic

City

Katowice

ZIP/Postal Code

40-555

Country

Poland

Facility Name

Neurology Center Krzysztof Selmaj

City

Lodz

ZIP/Postal Code

90-324

Country

Poland

Facility Name

Provincial Specialist Hospital in Olsztyn, Department of Neurology

City

Olsztyn

ZIP/Postal Code

10-561

Country

Poland

Facility Name

MED-Polonia, Sp. z o.o. (LLC)

City

Poznan

Country

Poland

Facility Name

NeuroProtect Medical Center

City

Warszawa

ZIP/Postal Code

01-684

Country

Poland

Facility Name

Clinical Center of Serbia, Clinic of Neurology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Clinical Hospital Center Zemun, Department of Neurology

City

Belgrade

ZIP/Postal Code

11080

Country

Serbia

Facility Name

Clinical Center Kragujevac, Clinic of Neurology

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Clinical Center of Vojvodina, Clinic of Neurology

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Cherkasy Regional Hospital of Cherkasy Oblast Council

City

Cherkasy

Country

Ukraine

Facility Name

Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital

City

Dnipro

Country

Ukraine

Facility Name

Ivano-Frankivsk City Clinical Hospital #1

City

Ivano-Frankivs'k

Country

Ukraine

Facility Name

Regional Clinical Hospital

City

Ivano-Frankivs'k

Country

Ukraine

Facility Name

City Clinical Hospital #7

City

Kharkiv

Country

Ukraine

Facility Name

Institute of Neurology, Psychiatry and Narcology

City

Kharkiv

Country

Ukraine

Facility Name

Kharkiv Railway Clinical Hospital

City

Kharkiv

Country

Ukraine

Facility Name

Kyiv City Clinical Hospital

City

Kyiv

Country

Ukraine

Facility Name

Medical Center of First Private Clinic

City

Kyiv

Country

Ukraine

Facility Name

National Research Center for Radiation Medicine

City

Kyiv

Country

Ukraine

Facility Name

Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

City

Lviv

Country

Ukraine

Facility Name

Lviv City Clinical Hospital #5

City

Lviv

Country

Ukraine

Facility Name

Center for Reconstructive and Restorative Medicine (University Clinic)

City

Odesa

Country

Ukraine

Facility Name

Sklifosovskyi Regional Clinical Hospital

City

Poltava

Country

Ukraine

Facility Name

Ternopil Regional Clinical Psychonevrological Hospital

City

Ternopil'

Country

Ukraine

Facility Name

Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital

City

Vinnytsia

Country

Ukraine

Facility Name

Clinical Hospital No. 9 under Zaporizhia City Council

City

Zaporizhia

Country

Ukraine

Facility Name

City Clinical Hospital #2

City

Zaporizhzhya

Country

Ukraine

Facility Name

Zaporizhia Regional Clinical Hospital

City

Zaporizhzhya

Country

Ukraine

Facility Name

O.F. Herbachevskyi Regional Clinical Hospital

City

Zhytomyr

ZIP/Postal Code

10008

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36689214

Citation

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 Jan 23;80(3):298-307. doi: 10.1001/jamaneurol.2022.5007. Online ahead of print.

Results Reference

result

Learn more about this trial

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

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