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

Korábbi kezelés

• Use of prohibited therapies.
• Plans for administration of live vaccines during the study period.
• 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.

Más betegség

• Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection.
• Uncontrolled co-existing serious disease.

Egyéb

• Pregnant or nursing (lactating) women.
• 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.

• 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.