Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572384
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease ILD Associated With Connective Tissue Disease CTD
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEconneCTD-ILD
Brief Summary:
Interstitial lung disease ILD is a lung condition resulting in inflammation and stiffening of the lung often associated with connective tissue diseases CTDs ILD causes reduction in lung volume shortness of breath cough and fatigue therefore has high impact on quality of life and is also the leading cause of death in participants with these conditions The study will assess whether treatment of CTD-ILD participants with belimumab in addition to standard therapy will result in the stabilization andor improvement of lung function and improve symptoms associated with ILD with an acceptable safety profile
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None