Clinical trial NCT06987851: An Extension Clinical Study of the Efficacy and Safety of BCD-132 in Patients With Multiple Sclerosis Who Previously Received Therapy in Clinical Studies of JSC BIOCAD
Official title: An Extension, Multicenter, Open-Label, Non-Comparative Clinical Study of the Efficacy and Safety of Long-Term Use of BCD-132 (JSC BIOCAD) in Patients With Multiple Sclerosis Who Previously Received Therapy in Clinical Studies of JSC BIOCAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis, relapsing multiple sclerosis, anti-CD20, DMT, divosilimab
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Written informed consent of the subject to participate in the study has been obtained.
* The subject was in the BCD-132 500 mg group in BCD-132-2, then transferred to BCD-132-4/MIRANTIBUS and completed it according to the Protocol (completed all scheduled study visits).
* Last administration of BCD-132 in BCD-132-4/MIRANTIBUS was performed at least 22 weeks before the planned date of the first drug administration in this clinical study.

Exclusion Criteria:

* Heart failure (NYHA class III/IV).
* Malignancies detected after completion of study BCD-132-4/MIRANTIBUS and prior to signing the informed consent to participate in this study, as well as conditions (acute and chronic) precluding further treatment and participation in the study in the Investigator's opinion.
* Metabolic abnormalities according to blood chemistry (including increased creatinine, urea, ALT, AST) and/or blood count abnormalities (including decreased white blood cell count, absolute lymphocyte count, absolute neutrophil count, platelet count, decreased hemoglobin concentration) identified at the screening and precluding further treatment and participation in the study in the Investigator's opinion.
* Pregnancy, breastfeeding, or planned pregnancy at any time during the participation in the study and 48 weeks after the scheduled last administration of the product in this study.
* Use, between the completion of participation in BCD-132-4/MIRANTIBUS and the signing of the informed consent for this study, of the following drugs: anti-B cell therapies (e.g., rituximab, ocrelizumab, abatacept, belimumab, ofatumumab, and others); alemtuzumab, daclizumab, teriflunomide, mitoxantrone, cladribine; cyclophosphamide, cyclosporine, azathioprine; mycophenolate mofetil, fingolimod and other sphingosine-1-phosphate (S1P) receptor modulators, natalizumab.
* Known intolerance, including hypersensitivity to any component of BCD-132, premedication drugs, or conditions in which the above drugs are contraindicated in the Investigator's opinion.
* Historical evidence of progressive multifocal leukoencephalopathy (PML).
* Contraindications to MRI and the use of gadolinium-containing contrast agents, including, but not limited to, the presence of metal foreign bodies, artificial heart valves, electronic middle ear implants, pacemakers; allergies to gadolinium or gadolinium-containing contrast agents.

Primary outcomes:
measure: Annualized relapse rate
timeFrame: 48 and 96 weeks
Secondary outcomes:
measure: Time to first relapse
timeFrame: 102 weeks
measure: Proportion of patients without confirmed relapses
timeFrame: 48 and 96 weeks
measure: Total number of T1 Gd+ lesions (per scan)
timeFrame: 48 and 100 weeks
measure: Proportion of patients without contrast-enhancing lesions
timeFrame: 48 and 100 weeks
measure: Proportion of patients without new or enlarging T2 lesions
timeFrame: 48 and 100 weeks
measure: Number of new or enlarged T2 lesions
timeFrame: 48 and 100 weeks
measure: Number of CUA (Combined Unique Active) lesions
timeFrame: 48 and 100 weeks
measure: Changes over time in neurological deficit parameters according to the Expanded Disability Status Scale (EDSS)
timeFrame: 102 weeks
measure: Changes over time in Timed 25-Foot Walk Test
timeFrame: 102 weeks
measure: Changes over time in 9-Hole Peg Test
timeFrame: 102 weeks
measure: Changes over time in Symbol Digit Modalities Test (SDMT)
timeFrame: 102 weeks
measure: Changes over time in quality of life indicators assessed with the SF-36 questionnaire
timeFrame: 102 weeks
Other outcomes:
Locations:
city: Kirov
country: Russian Federation
facility: Vyacheslav Andreyevich Dudin
city: Krasnoyarsk
country: Russian Federation
facility: Dmitry Vladimirovich Pokhabov
city: Moscow
country: Russian Federation
facility: Ivan Aleksandrovich Shchukin
city: Moscow
country: Russian Federation
facility: Sergey Viktorovich Kotov
city: Nizhny Novgorod
country: Russian Federation
facility: Elena Vladimirovna Parshina
city: Nizhny Novgorod
country: Russian Federation
facility: Irina Aleksandrovna Sokolova
city: Pyatigorsk
country: Russian Federation
facility: Gennady Nikolayevich Mishin
city: Rostov-on-don
country: Russian Federation
facility: Yuri Vladimirovich Trinitatsky
city: Rostov-on-Don
country: Russian Federation
facility: Zoya Aleksandrovna Goncharova
city: Samara
country: Russian Federation
facility: Irina Yevgenyevna Poverennova
city: St. Petersburg
country: Russian Federation
facility: Leonid Grigoryevich Zaslavsky
city: St. Petersburg
country: Russian Federation
facility: Natalya Agafonovna Totolyan
city: Tomsk
country: Russian Federation
facility: Valentina Mikhaylovna Alifirova
city: Tyumen
country: Russian Federation
facility: Stella Anatolyevna Sivertseva
city: Ulyanovsk
country: Russian Federation
facility: Irina Vladimirovna Greshnova
Study officials:
References: