NCT06411639

Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 .

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.

Conditions

• Sjogren Disease
• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	ianalumab	ianalumab will be provided in a pre-filled Syringe (PFS) of 150 mg/1 mL for s.c. administration. Two injections of 1mL each will be administered monthly.

Timeline

• Start date: 2024-11-25
• Primary completion: 2025-12-17
• Completion: 2028-06-24
• First posted: 2024-05-13
• Last updated: 2025-01-27