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

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocad

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