Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440746
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Efficacy and Safety of Olokizumab in Patients With Progressive Fibrosing Interstitial Lung Diseases
Sponsor:
R-Pharm International LLC
Organization:
R-Pharm
Study Overview
Official Title:
A Randomized Double-blind Parallel-group Placebo-controlled Multicenter Phase 23 Study of Efficacy and Safety of Olokizumab in Subjects With Progressive Fibrosing Interstitial Lung Diseases
Status:
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 purpose of this study is to evaluate efficacy and safety of olokizumab OKZ compared to placebo in patients progressive fibrosing Interstitial lung diseases ILD
Detailed Description:
This is a phase 23 study with double-blind parallel-group adaptive design
The study will include the following periods
1 Screening period 4 weeks Screening period before the first administration of the test drug Before being included in the study patients will be provided with complete information about this clinical trial and signs the Informed consent Form IF After that the researcher will decide whether or not the patient can be randomized into the study
2 Double-blind Treatment period 48 weeks Following the completion of a Treatment period all patients will be enrolled in Follow-up Period FU
3 Follow-up Period 24 weeks During the FU Period patients will visit study sites after 412 and 24 weeks after the end of the Treatment Period to complete FU-1 Week 52 FU-2 Week 60 and FU-3 Week 72 visits
The overall study duration for the patients will be approximately 76 weeks including the 4 weeks screening period
The analysis will be conducted in two sequential steps
the interim analysis after 60 percent of patients have completed the Treatment period not including the FU period
the final analysis when all patients have completed all periods the Treatment and the FU periods
The study will include the following periods
1 Screening period 4 weeks Screening period before the first administration of the test drug Before being included in the study patients will be provided with complete information about this clinical trial and signs the Informed consent Form IF After that the researcher will decide whether or not the patient can be randomized into the study
2 Double-blind Treatment period 48 weeks Following the completion of a Treatment period all patients will be enrolled in Follow-up Period FU
3 Follow-up Period 24 weeks During the FU Period patients will visit study sites after 412 and 24 weeks after the end of the Treatment Period to complete FU-1 Week 52 FU-2 Week 60 and FU-3 Week 72 visits
The overall study duration for the patients will be approximately 76 weeks including the 4 weeks screening period
The analysis will be conducted in two sequential steps
the interim analysis after 60 percent of patients have completed the Treatment period not including the FU period
the final analysis when all patients have completed all periods the Treatment and the FU periods
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