Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Launched by NOVARTIS PHARMACEUTICALS · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ianalumab, which is being tested to see how well it works and is absorbed in the body when given through two different types of injections for people with autoimmune diseases like rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus. The main goal is to compare the effects of a single 2 mL auto-injector dose with two 1 mL pre-filled syringe doses to find out if they provide similar benefits and to check how safe and tolerable the medication is for participants.

To join the study, participants need to be between 18 and 70 years old, weigh between 35 kg and 150 kg, and have a confirmed diagnosis of one of the targeted autoimmune diseases with active symptoms that could improve with this treatment. Participants will be required to have a stable treatment plan for at least four weeks before starting the study. Throughout the study, participants can expect to receive close monitoring and support from the research team, and they will need to follow specific guidelines regarding other medications and health conditions to ensure their safety.

Gender

ALL

Eligibility criteria

• Key Inclusion criteria:
• • Signed informed consent must be obtained before any assessment is performed.
• • Male and female patients aged 18 years to 70 years (inclusive).
• • Body weight at least 35 kg and not more than 150 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 RA, SjD and/or SLE as determined by the investigator.
• • Have active disease (RA, SjD 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.
• • Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study.
• 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.
• • Plans for administration of live vaccines during the study period.
• • 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.
• • US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment.
• • Other protocol-defined inclusion/exclusion criteria may apply.