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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 different injection methods for medication in adults with autoimmune disease.

Recruiting
18-70 years
All
Phase 2

This study tests a medicine called ianalumab, given by injections, to see how well it works and how safe it is for people with autoimmune diseases like rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). The study compares two ways of giving the medicine: one injection of 300 mg in a 2 mL auto-injector (AI) and two injections of 150 mg in 1 mL pre-filled syringes (PFS). There are two main parts: the first lasts from Week 0 to Week 24, and the second is an optional extended period until Week 72. After that, there is a follow-up period for safety checks. The study involves visits and tests to ensure the medicine's safety and to see how it works in the body. Participants must be adults aged 18-70 with active disease and meet certain health criteria. Women who can become pregnant must use effective birth control.

  • The study lasts up to 88 weeks, with an optional extended period.
  • Participants receive monthly injections and undergo regular check-ups.
  • Informed consent is required, and participants are compensated for their time.
Study details
    Sjögrens Disease
    Systemic Lupus Erythematosus
    Rheumatoid Arthritis

NCT06293365

Novartis Pharmaceuticals

7 June 2025

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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