Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333210
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-03-20
Brief Title:
Study of the Efficacy Safety Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis LEVENTA
Sponsor:
Biocad
Organization:
Biocad
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Clinical Study of the Efficacy and Safety of BCD-180 in Patients With Active Axial Spondyloarthritis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The aim of the study is to evaluate the efficacy safety immunogenicity pharmacokinetics and pharmacodynamics of a fixed dose of study drug BCD-180 in comparison with placebo in patients with active axial spondyloarthritis axSpA The study will include HLA-B27 patients with radiographic r-axSpA and non-radiographic nr-axSpA who had no response to prior therapy with non-steroidal anti-rheumatic drugs NSAIDs have not received biologic disease-modifying anti-rheumatic drugs bDMARDs or targeted synthetic disease-modifying antirheumatic drugs tsDMARDs and subjects with insufficient efficacy andor loss of efficacy on bDMARDs andor tsDMARDs
Detailed Description:
Subjects meeting the eligibility criteria will be randomized in 2 groupsbDMARDs andor tsDMARD naive subjects and bDMARDs andor tsDMARD experienced subjects will be randomized independently of each other
bDMARDs and tsDMARD-naive subjects naïve will be randomized into 3 groups
BCD-180 naïve
Placebo naïve
Adalimumab
bDMARDs andor tsDMARD experienced subjects exp will be randomized into 2 groups
BCD-180 exp
Placebo exp
After the primary endpoint assessment all subjects will be switched to BCD-180
bDMARDs and tsDMARD-naive subjects naïve will be randomized into 3 groups
BCD-180 naïve
Placebo naïve
Adalimumab
bDMARDs andor tsDMARD experienced subjects exp will be randomized into 2 groups
BCD-180 exp
Placebo exp
After the primary endpoint assessment all subjects will be switched to BCD-180
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