Adults 18 to 60, any sex, with Relapsing-Remitting Multiple Sclerosis (RRMS). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cumulative Number of New Active Lesions Over 24 WeeksPrimary· Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
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.
Group
Value
95% CI
PB006 (Per-Protocol)
1.4
± 3.73
Tysabri (Per-Protocol)
1.9
± 3.97
PB006 (Safety-Switch)
1.4
± 3.65
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
2.1
± 3.78
Tysabri Continued at Week 24 (Safety-Switch)
1.9
± 4.09
Cumulative Number of New Active Lesions Over 48 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
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 \[mmol/kg\].
Group
Value
95% CI
PB006 (Full Analysis Set)
1.5
± 3.72
Tysabri (Full Analysis Set)
2.3
± 5.68
PB006 (Safety-Switch)
1.5
± 3.75
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
2.1
± 3.82
Tysabri Continued at Week 24 (Safety-Switch)
2.3
± 5.70
Cumulative Number of New GdE T1-weighted Lesions Over 24 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
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 \[mmol/kg\].
Group
Value
95% CI
PB006 (Full Analysis Set)
0.3
± 1.01
Tysabri (Full Analysis Set)
0.4
± 1.25
PB006 (Safety-Switch)
0.3
± 1.02
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
0.4
± 0.81
Tysabri Continued at Week 24 (Safety-Switch)
0.4
± 1.37
Cumulative Number of New GdE T1-weighted Lesions Over 48 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
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 \[mmol/kg\].
Group
Value
95% CI
PB006 (Full Analysis Set)
0.3
± 1.02
Tysabri (Full Analysis Set)
0.4
± 1.39
PB006 (Safety-Switch)
0.3
± 1.03
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
0.4
± 0.82
Tysabri Continued at Week 24 (Safety-Switch)
0.4
± 1.40
Number of Patients Without New GdE T1-weighted Lesions Over 24 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
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 \[mmol/kg\].
Group
Value
95% CI
PB006 (Full Analysis Set)
109
Tysabri (Full Analysis Set)
105
PB006 (Safety-Switch)
105
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
23
Tysabri Continued at Week 24 (Safety-Switch)
80
Number of Patients Without New GdE T1-weighted Lesions Over 48 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
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 \[mmol/kg\].
Group
Value
95% CI
PB006 (Full Analysis Set)
105
Tysabri (Full Analysis Set)
80
PB006 (Safety-Switch)
102
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
22
Tysabri Continued at Week 24 (Safety-Switch)
79
Cumulative Number of New/Enlarging T2-weighted Lesions Over 24 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
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.
Group
Value
95% CI
PB006 (Full Analysis Set)
1.5
± 3.79
Tysabri (Full Analysis Set)
2.0
± 4.12
PB006 (Safety-Switch)
1.5
± 3.83
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
2.2
± 3.84
Tysabri Continued at Week 24 (Safety-Switch)
2.0
± 4.25
Cumulative Number of New/Enlarging T2-weighted Lesions Over 48 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
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.
Group
Value
95% CI
PB006 (Full Analysis Set)
1.6
± 3.09
Tysabri (Full Analysis Set)
2.4
± 5.79
PB006 (Safety-Switch)
1.6
± 3.93
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
2.2
± 3.89
Tysabri Continued at Week 24 (Safety-Switch)
2.5
± 5.81
Number of Persistent Lesions After 24 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
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 \[mmol/kg\].
Group
Value
95% CI
PB006 (Full Analysis Set)
0.5
± 2.46
Tysabri (Full Analysis Set)
0.4
± 2.92
PB006 (Safety-Switch)
0.5
± 2.49
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
0.1
± 0.31
Tysabri Continued at Week 24 (Safety-Switch)
0.6
± 3.37
Number of Persistent Lesions After 48 WeeksSecondary· Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
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 \[mmol/kg\].
Group
Value
95% CI
PB006 (Full Analysis Set)
0.5
± 2.55
Tysabri (Full Analysis Set)
0.6
± 3.35
PB006 (Safety-Switch)
0.5
± 2.58
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
0.1
± 0.26
Tysabri Continued at Week 24 (Safety-Switch)
0.6
± 3.37
Annualized Relapse Rate After 24 WeeksSecondary· Up to 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) /
Group
Value
95% CI
PB006 (Full Analysis Set)
0.206
Tysabri (Full Analysis Set)
0.152
PB006 (Safety-Switch)
0.194
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
0.143
Tysabri Continued at Week 24 (Safety-Switch)
0.114
Annualized Relapse Rate After 48 WeeksSecondary· Up to 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) /
Group
Value
95% CI
PB006 (Full Analysis Set)
0.174
Tysabri (Full Analysis Set)
0.133
PB006 (Safety-Switch)
0.168
Tysabri Switched to PB006 at Week 24 (Safety-Switch)
0.146
Tysabri Continued at Week 24 (Safety-Switch)
0.113
Adverse events — posted to ClinicalTrials.gov
Time frame: From first infusion till the last + 4 weeks, up to 48 weeks. Deaths (all causes): From first infusion till the last (at Week 44) + 24 ± 2 weeks, up to 68 ± 2 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
PB006
Serious: 3/161 (2%)
Deaths: 0/161
Tysabri
Serious: 2/133 (2%)
Deaths: 0/133
Serious adverse events (5 terms)
Reaction
System
PB006
Tysabri
Hypotension
Vascular disorders
—
—
Tremor
Nervous system disorders
—
—
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
—
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
—
Pneumonia
Infections and infestations
—
—
Other adverse events (152 terms — click to expand)
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Polpharma Biologics S.A.
Last refreshed: 3 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04115488.