Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Launched by NOVARTIS PHARMACEUTICALS · May 8, 2024

Keywords

ClinConnect Summary

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 Peri...

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Male and female patients 18 years to 70 years of age (inclusive)
• • Body weight at least 35 kg and not more than 120 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 at screening
• • Diagnosed with SjD and/or SLE as determined by the investigator
• • Have active disease (SjD and/or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
• • Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment
• Key Exclusion Criteria:
• • Use of prohibited therapies
• • Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection
• • Receipt of live/attenuated vaccine within a 4-week period before first dosing
• • Uncontrolled co-existing serious disease
• • Pregnant or nursing (lactating) women
• • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug
• • Other protocol-defined inclusion/exclusion criteria may apply.