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Comparing two methods of administering ianalumab for autoimmune diseases

A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Phase 2 Interventional Novartis · NCT06293365

This study is testing two different ways to give a treatment called ianalumab to see which method works better for people with autoimmune diseases like rheumatoid arthritis, Sjögren's disease, or systemic lupus erythematosus.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment140 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsianalumab
Locations36 sites (Anniston, Alabama and 35 other locations)
Trial IDNCT06293365 on ClinicalTrials.gov

What this trial studies

This study aims to compare the pharmacokinetics of ianalumab, a treatment for autoimmune diseases, administered via two different methods: a 2 mL auto-injector and a 1 mL pre-filled syringe. Participants will be randomized into two treatment sequences over a 24-week period, receiving either method of administration while also receiving standard of care (SoC) treatment. The study will evaluate both the safety and tolerability of ianalumab in patients diagnosed with rheumatoid arthritis, Sjögren's disease, or systemic lupus erythematosus. A second cohort will further assess the comparability of pharmacokinetics between different dosing regimens of the pre-filled syringe.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with active rheumatoid arthritis, Sjögren's disease, or systemic lupus erythematosus who may benefit from B-cell depletion therapy.

Not a fit: Patients with active infections or those using prohibited therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and convenient method of administering ianalumab for patients with autoimmune diseases.

How similar studies have performed: Other studies have shown success with similar pharmacokinetic comparisons, suggesting this approach is promising.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Anniston, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sjögrens DiseaseSystemic Lupus ErythematosusRheumatoid ArthritisSystemic lupus erythematosusPharmacokinetic comparability2 mL auto-injector1 mL pre-filled syringe2 mL pre-filled syringe
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.