Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous I… (NCT06293365) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States, Argentina, Canada155 participantsStarted 2024-07-02
Plain-language summary
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).
A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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):…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically comparing how the body absorbs ianalumab from two different injection devices — a 2mL auto-injector versus a 1mL pre-filled syringe — rather than testing whether ianalumab works better than existing treatments, so is the main goal here just to validate the delivery device, and what does that mean for any direct benefit to me as a participant?
2Since this is a Phase 2 crossover study where I would receive both injection methods at different points, can you walk me through what the study schedule actually looks like in terms of clinic visits, blood draws, and time commitment, and is that realistic given my current health and life situation?
3The trial is listed as active but no longer recruiting, so could I still potentially be considered for participation, or would you recommend I focus my energy on other options?
4Given that I have Sjögren's disease, lupus, or rheumatoid arthritis, are there standard-of-care treatments I should be trying first, or would participating in a pharmacokinetics study like this fit alongside my existing treatment plan rather than replace it?
5Since the study is measuring drug concentration levels in my blood rather than tracking whether my disease symptoms improve, how would you and I know if ianalumab itself is actually helping my condition, and is there a separate pathway for me to access this drug therapeutically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
Timeframe: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
2
Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
Timeframe: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
3
Cohort 2: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab
Timeframe: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).
4
Cohort 2: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab
Timeframe: Over a dosing interval after 3rd (between Week 8 and 12) and 6th dose (between Week 20 and 24).