Neuromyelitis Optica Spectrum DisordersPhase 3AQUARELLENCT05730699
Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)
A Phase 3 study testing divozilimab in people with Neuromyelitis Optica Spectrum Disorders, run by Biocad at 19 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders
- What is being tested?
- divozilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 19 sitesRussia
- Study dates
- 12 Dec 2022to Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Llc "Profimed"
Barnaul
Municipal Autonomous Healthcare Institution of the Order of the Red Banner of Labor "City Clinical Hospital No.1"
Chelyabinsk
Regional Clinical Hospital No.3
Chelyabinsk
Kuzbass Clinical Hospital named after S.V. Belyaev
Kemerovo
Khanty-Mansiysk autonomous district - Ugra "The district clinical hospital"
Khanty-Mansiysk
Center for Cardiology and Neurology
Kirov
Regional Clinical Hospital № 1 named after Professor S. V. Ochapovsky
Krasnodar
Moscow Regional Clinical Research Institute named after M.F. Vladimirsky (MONIKI)
Moscow
LLC "Medis"
Nizhny Novgorod
Semashko Regional Clinical Hospital
Nizhny Novgorod
State Novosibirsk Regional Clinical Hospital
Novosibirsk
Pyatigorsk City Clinical Hospital No.2
Pyatigorsk
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
Rostov-on-Don
Pavlov First Saint Petersburg State Medical University
Saint Petersburg
Seredavin Regional Clinical Hospital
Samara
Republican Clinical Hospital No.4
Saransk
Siberian State Medical University
Tomsk
Medical and Sanitary Unit "Neftyanik"
Tyumen
Ulyanovsk Regional Clinical Hospital
Ulyanovsk
About this study
Official title: An Open-Label Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders
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).
Read the 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
- Being tested
- divozilimab
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
divozilimabBiological
anti-CD20 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| BCD-132 (divozilimab) | Experimental | Intravenous infusion of BCD-132 every 24 weeks Receives: Biological: divozilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated annualized relapse rate [Week 24]
Adjudicated annualized relapse rate
Measured: Week 24
Secondary outcomes (10)
Time to the first adjudicated relapse
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
Measured: Week 100
Adjudicated annualized relapse rate
Adjudicated annualized relapse rate
Measured: Week 52, 100
Proportion of subjects without adjudicated relapses
Proportion of subjects without adjudicated relapses at week 24, 52, 100
Measured: Weeks 24, 52, 100
Change in the Expanded Disability Status Scale (EDSS) score
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.
Measured: Week 24, 52, 100
Proportion of subjects with confirmed increase in disability
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
Measured: Weeks 24, 26, 48, 52, 100
Vision acuity change
Vision acuity change at Week 24, 52, 100 relative to baseline
Measured: Week 24, 52, 100
Change in the Timed 25-Foot (7.62 m) Walk (T25-FW) test
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.
Measured: Up to Week 100
Changes in the severity of pain using a Numeric Rating Scale
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.
Measured: Week 4, 24, 52, 100
Change in the quality of life using a SF-36
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.
Measured: Week 24, 52, 100
CUA
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
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start12 Dec 2022
- Primary completionJan 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730699
- Sponsor's protocol ID
- BCD-132-6
- Acronym
- AQUARELLE
- Status last verified
- Nov 2024
- First submitted
- 7 Feb 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders
- ClinicalTrials.gov ID
- NCT05730699
- Acronym / sponsor ID
- AQUARELLE / BCD-132-6
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCD-132 (divozilimab) | Experimental | Biological: divozilimabIntravenous infusion of BCD-132 every 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| divozilimabanti-CD20 monoclonal antibody | Biological | BCD-132 (divozilimab) |
Primary outcome
Adjudicated annualized relapse rate [Week 24]
Time frame: Week 24
Adjudicated annualized relapse rate
10 secondary outcomes
Time to the first adjudicated relapse
Time frame: Week 100
Adjudicated annualized relapse rate
Time frame: Week 52, 100
Proportion of subjects without adjudicated relapses
Time frame: Weeks 24, 52, 100
Change in the Expanded Disability Status Scale (EDSS) score
Time frame: Week 24, 52, 100
Proportion of subjects with confirmed increase in disability
Time frame: Weeks 24, 26, 48, 52, 100
Vision acuity change
Time frame: Week 24, 52, 100
Change in the Timed 25-Foot (7.62 m) Walk (T25-FW) test
Time frame: Up to Week 100
Changes in the severity of pain using a Numeric Rating Scale
Time frame: Week 4, 24, 52, 100
Change in the quality of life using a SF-36
Time frame: Week 24, 52, 100
CUA
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing divozilimab in people with Neuromyelitis Optica Spectrum Disorders, run by Biocad at 19 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjudicated annualized relapse rate [Week 24] (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.