Trials / Active Not Recruiting
Active Not RecruitingNCT05730699
Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)
An Open-Label Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | divozilimab | anti-CD20 monoclonal antibody |
Timeline
- Start date
- 2022-12-12
- Primary completion
- 2025-01-01
- Completion
- 2026-09-01
- First posted
- 2023-02-16
- Last updated
- 2024-11-07
Locations
19 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05730699. Inclusion in this directory is not an endorsement.