The aim of this clinical study is to assess the long-term efficacy and safety of BCD-132 (divozilimab) in patients with multiple sclerosis who previously participaded in BCD-132-2 and BCD-132-4/MIRANTIBUS studies
Clinical study BCD-132-EXT is a Phase III study extension conducted after completion of BCD-132 500 mg therapy by subjects of clinical studies BCD-132-2 and BCD-132-4/MIRANTIBUS. The study is designed as a multicenter, open-label, non-randomized, non-comparative, single-arm clinical study. The study consists of a screening period (14 days), a treatment period (96 weeks) and a follow-up period (4 weeks). During treatment period, the subjects will receive the investigational product BCD-132 (divozilimab). The duration of participation for each subject will be approximately 102 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Intravenous infusion of BCD-132 every 24 weeks
Vyacheslav Andreyevich Dudin
Kirov, Russia
Dmitry Vladimirovich Pokhabov
Krasnoyarsk, Russia
Ivan Aleksandrovich Shchukin
Moscow, Russia
Annualized relapse rate
Time frame: 48 and 96 weeks
Time to first relapse
Time frame: 102 weeks
Proportion of patients without confirmed relapses
Time frame: 48 and 96 weeks
Total number of T1 Gd+ lesions (per scan)
Time frame: 48 and 100 weeks
Proportion of patients without contrast-enhancing lesions
Time frame: 48 and 100 weeks
Proportion of patients without new or enlarging T2 lesions
Time frame: 48 and 100 weeks
Number of new or enlarged T2 lesions
Time frame: 48 and 100 weeks
Number of CUA (Combined Unique Active) lesions
Total number of new contrast-enhancing T1 lesions and new T2 lesions or enlarged T2-weighted lesions without double counting on MRI (Combined Unique Active)
Time frame: 48 and 100 weeks
Changes over time in neurological deficit parameters according to the Expanded Disability Status Scale (EDSS)
Time frame: 102 weeks
Changes over time in Timed 25-Foot Walk Test
Time frame: 102 weeks
Changes over time in 9-Hole Peg Test
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Sergey Viktorovich Kotov
Moscow, Russia
Elena Vladimirovna Parshina
Nizhny Novgorod, Russia
Irina Aleksandrovna Sokolova
Nizhny Novgorod, Russia
Gennady Nikolayevich Mishin
Pyatigorsk, Russia
Yuri Vladimirovich Trinitatsky
Rostov-on-Don, Russia
Zoya Aleksandrovna Goncharova
Rostov-on-Don, Russia
Leonid Grigoryevich Zaslavsky
Saint Petersburg, Russia
...and 5 more locations
Time frame: 102 weeks
Changes over time in Symbol Digit Modalities Test (SDMT)
Time frame: 102 weeks
Changes over time in quality of life indicators assessed with the SF-36 questionnaire
Time frame: 102 weeks