Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison
Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Intravenous (IV) infusions
Results by group
Cumulative Number of New Active Lesions Over 24 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| PB006 (Per-Protocol) | 1.4 lesions | 3.73 (Standard Deviation) | 111 |
| Tysabri (Per-Protocol) | 1.9 lesions | 3.97 (Standard Deviation) | 118 |
| PB006 (Safety-Switch) | 1.4 lesions | 3.65 (Standard Deviation) | 122 |
| Tysabri Switched to PB006 at Week 24 (Safety-Switch) | 2.1 lesions | 3.78 (Standard Deviation) | 30 |
| Tysabri Continued at Week 24 (Safety-Switch) | 1.9 lesions | 4.09 (Standard Deviation) | 95 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| PB006 | 161 | 3 (1.9%) | 0 |
| Tysabri | 133 | 2 (1.5%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Cumulative Number of New Active Lesions Over 24 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
MRI lesions
Other measures (34)
Cumulative Number of New Active Lesions Over 48 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
MRI lesionsCumulative Number of New GdE T1-weighted Lesions Over 24 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
MRI lesionsCumulative Number of New GdE T1-weighted Lesions Over 48 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
MRI lesionsNumber of Patients Without New GdE T1-weighted Lesions Over 24 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
MRI lesionsNumber of Patients Without New GdE T1-weighted Lesions Over 48 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
MRI lesionsCumulative Number of New/Enlarging T2-weighted Lesions Over 24 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
MRI lesionsCumulative Number of New/Enlarging T2-weighted Lesions Over 48 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
MRI lesionsNumber of Persistent Lesions After 24 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20 and 24.
MRI lesionsNumber of Persistent Lesions After 48 Weeks
Scans performed at week 0 (baseline), week 8, 16, 20, 24 and 48.
MRI lesionsAnnualized Relapse Rate After 24 Weeks
Up to 24 weeks.
Relapses
Who could take part
Relapsing MS · 18 to 60 · EDSS 0 to 5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile.Front Immunol · 2024
Results
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
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History
Started
Oct 2019
Main results due
Aug 2021
Finished
Feb 2022
Results posted
Jul 2023