Status:
COMPLETED
Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®
Lead Sponsor:
Polpharma Biologics S.A.
Conditions:
Relapsing-Remitting Multiple Sclerosis (RRMS)
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 scle...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT04115488
Start Date
October 1 2019
End Date
February 7 2022
Last Update
July 3 2023
Active Locations (48)
Enter a location and click search to find clinical trials sorted by distance.
1
Grodno Regional Clinical Hospital
Grodno, Belarus, 230017
2
Minsk City Clinical Hospital #5
Minsk, Belarus, 220026
3
Republican Research and Development Center for Neurology and Neurosurgery
Minsk, Belarus, 220114
4
Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology
Minsk, Belarus, 220116