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NCT Number: NCT05730699

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Llc "Profimed", Barnaul, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Divozilimab

Biological

anti-CD20 monoclonal antibody

Primary outcomes

  1. Adjudicated annualized relapse rate [Week 24]

    Time frame: Week 24

    Adjudicated annualized relapse rate

Secondary outcomes

  1. Time to the first adjudicated relapse

    Time frame: Week 100

    Time to the first adjudicated relapse is defined as the time from the date of randomization in the study to the date of the onset of symptoms of the adjudicated relapse. Each relapse will be adjudicated by an independent neurological commission

  2. Adjudicated annualized relapse rate

    Time frame: Week 52, 100

    Adjudicated annualized relapse rate

  3. Proportion of subjects without adjudicated relapses

    Time frame: Weeks 24, 52, 100

    Proportion of subjects without adjudicated relapses at week 24, 52, 100

  4. Change in the Expanded Disability Status Scale (EDSS) score

    Time frame: Week 24, 52, 100

    Change in the Expanded Disability Status Scale (EDSS) at week 24, 52, 100 relative to baseline.The EDSS ranges from 0 to 10. An increase in EDSS values corresponds to a worsening disability.

  5. Proportion of subjects with confirmed increase in disability

    Time frame: Weeks 24, 26, 48, 52, 100

    Confirmed increase in disability is defined as an increase in the EDSS score (not related to a previous relapse and assuming there is no relapse at assessment) compared to Day 1 (baseline) by at least 1.5 in subjects with a baseline score of 0; by at least 1.0 in subjects with a baseline score of > 0 and ≤ 5.5; and by at least 0.5 in subjects with a baseline score of ≥ 6.0 persisting for ≥ 3 months

  6. Vision acuity change

    Time frame: Week 24, 52, 100

    Vision acuity change at Week 24, 52, 100 relative to baseline

  7. Change in the Timed 25-Foot (7.62 m) Walk (T25-FW) test

    Time frame: Up to Week 100

    Change in the Timed 25-Foot (7.62 m) Walk (T25-FW) test over time compared to baseline.

    T25-FW test is a way to quantify lower limb functions. The subject standing at one end of a clearly marked 25-foot (7.62-meter) course is asked to walk the distance as quickly but as safely as possible. After the first attempt, the subject is asked to walk the same distance again. The results (time in seconds) of both attempts are recorded.

  8. Changes in the severity of pain using a Numeric Rating Scale

    Time frame: Week 4, 24, 52, 100

    Changes in the severity of pain at Week 4, 24, 52, 100 relative to baseline. The Numerical Rating Scale (NRS) will be used to assess the intensity of the subject's pain. NRS consists of consecutive numbers from 0 to 10, where 0 is no pain and 10 is the most severe pain that can be imagined.

  9. Change in the quality of life using a SF-36

    Time frame: Week 24, 52, 100

    Change in the quality of life parameters using a SF-36 questionnaire at week 24, 52, 100 relative to baseline. SF-36 (Short Form-36) questionnaire includes a total of 36 questions.

  10. CUA

    Time frame: Week 24

    CUA (Cumulative Total Active) - • Cumulative number of new Gd-enhancing T1-weighted lesions and new T2-weighted lesions or enlarging T2-weighted lesions without double counting

Sponsors and collaborators

Lead sponsor

Biocad

Industry

Registry information

Official study title

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

Acronym: AQUARELLE

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 16, 2023
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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