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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

Study comparing ianalumab injections for autoimmune disease patients.

Recruiting
18-70 years
All
Phase 2

Ianalumab is a medicine given by injection to help people with autoimmune diseases like rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). This study compares two ways of giving ianalumab: a 2 mL auto-injector (AI) and a 1 mL pre-filled syringe (PFS). The goal is to see if both methods work similarly and are safe. The study lasts up to 88 weeks, with an optional extended period up to 176 weeks.

Key points:

  • The study has three parts: screening (up to 4 weeks), treatment (up to 72 weeks), and follow-up (up to 176 weeks).
  • Participants must be adults (18-70 years old) with specific autoimmune diseases and meet other health criteria.
  • Participants will not receive live vaccines and must use contraception if they can become pregnant.
Study details
    Sjögrens Disease
    Systemic Lupus Erythematosus
    Rheumatoid Arthritis

NCT06293365

Novartis Pharmaceuticals

5 January 2025

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