Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411639
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multicenter Open-label Single-arm Multiple-dose Study to Characterize the Pharmacokinetics Safety and Tolerability of Subcutaneous Ianalumab in Chinese Adult Participants With Autoimmune Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 pharmacokinetic PK study is to describe the PK profile of ianalumab following sc administration in Chinese participants with systemic lupus erythematosus SLE andor Sjögrens disease SjD Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 NCT05349214 and lupus nephritis LN CVAY736K12301 NCT05126277 on an optional basis This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies
Detailed Description:
The study consists of the following periods
Screening Period up to 4 weeks
Treatment Period Week 0 - Week 12 12 weeks
Extended Treatment Period after the completion of Week 12 - Week 52 End of Treatment EoT 40 weeks
After completion of the 12-week treatment participants will have the option to enter the Extended Treatment Period If a participant does not enter the Extended Treatment Period the EoT visit will be performed at the next planned visit following the completion of Week 12 followed by the Post-treatment Follow-up Period
Post-treatment Follow-up Period at least 20 weeks and up to 2 years from the last dose of study treatment
Screening Period up to 4 weeks
Treatment Period Week 0 - Week 12 12 weeks
Extended Treatment Period after the completion of Week 12 - Week 52 End of Treatment EoT 40 weeks
After completion of the 12-week treatment participants will have the option to enter the Extended Treatment Period If a participant does not enter the Extended Treatment Period the EoT visit will be performed at the next planned visit following the completion of Week 12 followed by the Post-treatment Follow-up Period
Post-treatment Follow-up Period at least 20 weeks and up to 2 years from the last dose of study treatment
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