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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
The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's 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 .
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Start Date
November 25, 2024
Primary Completion Date
December 17, 2025
Completion Date
June 24, 2028
Last Updated
January 27, 2025
ianalumab
DRUG
Lead Sponsor
Novartis Pharmaceuticals
NCT06647069
NCT07371468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06333483