Clinical trial NCT05730699: Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)
Official title: An Open-Label Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neuromyelitis Optica Spectrum Disorders
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Adjudicated annualized relapse rate [Week 24]
timeFrame: Week 24
Secondary outcomes:
measure: Time to the first adjudicated relapse
timeFrame: Week 100
measure: Adjudicated annualized relapse rate
timeFrame: Week 52, 100
measure: Proportion of subjects without adjudicated relapses
timeFrame: Weeks 24, 52, 100
measure: Change in the Expanded Disability Status Scale (EDSS) score
timeFrame: Week 24, 52, 100
measure: Proportion of subjects with confirmed increase in disability
timeFrame: Weeks 24, 26, 48, 52, 100
measure: Vision acuity change
timeFrame: Week 24, 52, 100
measure: Change in the Timed 25-Foot (7.62 m) Walk (T25-FW) test
timeFrame: Up to Week 100
measure: Changes in the severity of pain using a Numeric Rating Scale
timeFrame: Week 4, 24, 52, 100
measure: Change in the quality of life using a SF-36
timeFrame: Week 24, 52, 100
measure: CUA
timeFrame: Week 24
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Llc "Profimed"
city: Chelyabinsk
country: Russian Federation
facility: Municipal Autonomous Healthcare Institution of the Order of the Red Banner of Labor "City Clinical Hospital No.1"
city: Chelyabinsk
country: Russian Federation
facility: Regional Clinical Hospital No.3
city: Kemerovo
country: Russian Federation
facility: Kuzbass Clinical Hospital named after S.V. Belyaev
city: Khanty-Mansiysk
country: Russian Federation
facility: Khanty-Mansiysk autonomous district - Ugra "The district clinical hospital"
city: Kirov
country: Russian Federation
facility: Center for Cardiology and Neurology
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital № 1 named after Professor S. V. Ochapovsky
city: Moscow
country: Russian Federation
facility: Moscow Regional Clinical Research Institute named after M.F. Vladimirsky (MONIKI)
city: Nischni Nowgorod
country: Russian Federation
facility: Semashko Regional Clinical Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: LLC "Medis"
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk City Clinical Hospital No.2
city: Rostov-on-Don
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University"
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Samara
country: Russian Federation
facility: Seredavin Regional Clinical Hospital
city: Saransk
country: Russian Federation
facility: Republican Clinical Hospital No.4
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Tyumen
country: Russian Federation
facility: Medical and Sanitary Unit "Neftyanik"
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital
Study officials:
References: