Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)

NCT ID: NCT05730699

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2026-09-30

Brief Summary

The goal of this clinical trial is to study the efficacy and safety of BCD-132 (divozilimab) in subjects with neuromyelitis optica spectrum disorders (NMOSD).

Detailed Description

BCD-132-6/AQUARELLE is an open-label phase 3 clinical study in subjects with NMOSD. Approximately 105 subjects will be enrolled.

The study consists of a screening period, a treatment period and a follow-up period. During treatment period, the subjects will receive the investigational product divozilimab.

The duration of participation for each subject will be approximately 104 weeks.

Conditions

Neuromyelitis Optica Spectrum Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BCD-132 (divozilimab)

Intravenous infusion of BCD-132 every 24 weeks

Group Type: EXPERIMENTAL

divozilimab

Intervention Type: BIOLOGICAL

anti-CD20 monoclonal antibody

Interventions

divozilimab

anti-CD20 monoclonal antibody

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria
• Documented evidence of at least 1 relapse within 12 months before signing the informed consent form, or 2 relapses within 24 months before signing the informed consent form
• A total EDSS score of ≤ 7
• Presence of IgG antibodies to the Varicella Zoster virus at screening
• A CD19+ cell proportion of ≥ 1 % of the total lymphocyte count in patients exposed to other anti-B-cell therapies more than 6 months before signing the informed consent form

Exclusion Criteria

• A relapse occurring less than 30 days before signing the informed consent form or at screening (patients may be re-screened)
• Intrathecal oligoclonal or monoclonal IgG production (in patients who are anti-AQP4 seronegative)
• Other nervous system disorders (including multiple sclerosis) that can mask or affect the assessment of NMOSD symptoms
• History of other autoimmune diseases requiring immunosuppressive therapy
• Prior exposure to: alemtuzumab, total lymphatic irradiation, bone marrow transplantation; anti-B-cell therapy drugs, abatacept, satralizumab within 6 months prior to signing the informed consent form; mitoxantrone, cyclophosphamide, methotrexate, cyclosporine A, tacrolimus, eculizumab, tocilizumab, natalizumab, interferon beta, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate within 3 months before signing the informed consent form; immunoglobulin products within 30 days before signing the informed consent form; transfusion of blood or blood components within 30 days before signing the informed consent form; systemic corticosteroids at the time of signing the informed consent form

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Llc "Profimed"

Barnaul, , Russia

Municipal Autonomous Healthcare Institution of the Order of the Red Banner of Labor "City Clinical Hospital No.1"

Chelyabinsk, , Russia

Regional Clinical Hospital No.3

Chelyabinsk, , Russia

Kuzbass Clinical Hospital named after S.V. Belyaev

Kemerovo, , Russia

Khanty-Mansiysk autonomous district - Ugra "The district clinical hospital"

Khanty-Mansiysk, , Russia

Center for Cardiology and Neurology

Kirov, , Russia

Regional Clinical Hospital № 1 named after Professor S. V. Ochapovsky

Krasnodar, , Russia

Moscow Regional Clinical Research Institute named after M.F. Vladimirsky (MONIKI)

Moscow, , Russia

LLC "Medis"

Nizhny Novgorod, , Russia

Semashko Regional Clinical Hospital

Nizhny Novgorod, , Russia

State Novosibirsk Regional Clinical Hospital

Novosibirsk, , Russia

Pyatigorsk City Clinical Hospital No.2

Pyatigorsk, , Russia

Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"

Rostov-on-Don, , Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Seredavin Regional Clinical Hospital

Samara, , Russia

Republican Clinical Hospital No.4

Saransk, , Russia

Siberian State Medical University

Tomsk, , Russia

Medical and Sanitary Unit "Neftyanik"

Tyumen, , Russia

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, , Russia

Countries

Russia

Other Identifiers

BCD-132-6

Identifier Type: -

Identifier Source: org_study_id