Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-11-13
Brief Title:
A Randomized Double-blind Placebo-controlled Phase II Clinical Study to Evaluate the Safety Tolerability Efficacy and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease
Sponsor:
Changchun GeneScience Pharmaceutical Co Ltd
Organization:
Changchun GeneScience Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase II Clinical Study to Evaluate the Safety Tolerability Efficacy and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
This study was conducted in a randomized double-blind placebo-controlled design to evaluate the efficacy and safety of Genakumab injection in the treatment of CTD-ILD including Rheumatoid Arthritis associated Interstitial Lung Disease RA-ILD and Systemic Sclerosis associated Interstitial Lung Disease SSc-ILD
Detailed Description:
None
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