Loading clinical trials...

ACTIVE_NOT_RECRUITINGPHASE3

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

An Open-Label Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders

NCT05730699•Biocad

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (19)

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

Key Dates

Start Date

December 12, 2022

Primary Completion Date

January 1, 2025

Completion Date

September 1, 2026

Last Updated

November 7, 2024

Enrollment

105

ESTIMATED participants

Conditions

Neuromyelitis Optica Spectrum Disorders

Interventions

divozilimab

BIOLOGICAL

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

NCT06620809

Neuromyelitis Optica Spectrum Disorders

View study

RECRUITING

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

NCT07202494

Multiple SclerosisNeuromyelitis Optica Spectrum Disorders+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging

A Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)

Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.

An Open Label Study of the Effects of SHR1459 in NMOSDs Patients

The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)