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

NCT05730699 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: BCD-132-6
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 19

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).

Conditions

Neuromyelitis Optica Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• Adjudicated annualized relapse rate [Week 24]

  Adjudicated annualized relapse rate

  Week 24

Secondary Outcomes (10)

• Time to the first adjudicated relapse

  Week 100

• Adjudicated annualized relapse rate

  Week 52, 100

• Proportion of subjects without adjudicated relapses

  Weeks 24, 52, 100

• Change in the Expanded Disability Status Scale (EDSS) score

  Week 24, 52, 100

• Proportion of subjects with confirmed increase in disability

  Weeks 24, 26, 48, 52, 100

Study Arms (1)

BCD-132 (divozilimab)

EXPERIMENTAL

Intravenous infusion of BCD-132 every 24 weeks

Biological: divozilimab

Interventions

divozilimab BIOLOGICAL

anti-CD20 monoclonal antibody

BCD-132 (divozilimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocad: lead

Study Sites (19)

Llc "Profimed"

Barnaul, Russia

Location

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

Chelyabinsk, Russia

Location

Regional Clinical Hospital No.3

Chelyabinsk, Russia

Location

Kuzbass Clinical Hospital named after S.V. Belyaev

Kemerovo, Russia

Location

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

Khanty-Mansiysk, Russia

Location

Center for Cardiology and Neurology

Kirov, Russia

Location

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

Krasnodar, Russia

Location

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

Moscow, Russia

Location

LLC "Medis"

Nizhny Novgorod, Russia

Location

Semashko Regional Clinical Hospital

Nizhny Novgorod, Russia

Location

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Russia

Location

Pyatigorsk City Clinical Hospital No.2

Pyatigorsk, Russia

Location

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

Rostov-on-Don, Russia

Location

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Russia

Location

Seredavin Regional Clinical Hospital

Samara, Russia

Location

Republican Clinical Hospital No.4

Saransk, Russia

Location

Siberian State Medical University

Tomsk, Russia

Location

Medical and Sanitary Unit "Neftyanik"

Tyumen, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Russia

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: December 12, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

RU (19)