Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730699
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2023-02-07
Brief Title:
Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders AQUARELLE
Sponsor:
Biocad
Organization:
Biocad
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AQUARELLE
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-132-6AQUARELLE is a randomized double-blind placebo-controlled phase 3 clinical study in subjects with NMOSD Eligible subjects will be randomized at a 21 ratio to the divozilimab and placebo groups respectively At randomization subjects will be stratified according to the presence of anti-AQP4 antibodies and number of relapses during the past 12 months Approximately 105 subjects will be enrolled
The study consists of a screening period a treatment period Stage 1 and Stage 2 and a follow-up periodThe maximum duration of Stage 1 will be about 24 weeks During Stage 1 the subjects will receive one dose of the investigational product divozilimabplacebo During Stage 2 all subjects both in the divozilimab and placebo groups will receive therapy with divozilimab
The duration of participation for each subject will be approximately 56 weeks
The study consists of a screening period a treatment period Stage 1 and Stage 2 and a follow-up periodThe maximum duration of Stage 1 will be about 24 weeks During Stage 1 the subjects will receive one dose of the investigational product divozilimabplacebo During Stage 2 all subjects both in the divozilimab and placebo groups will receive therapy with divozilimab
The duration of participation for each subject will be approximately 56 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None