Active not recruitingPHASE2INTERVENTIONAL

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

This research study is looking at a drug called ianalumab, which is used to treat autoimmune conditions such as Sjögren's disease, systemic lupus erythematosus (lupus), and rheumatoid arthritis. The main goal is to check if different ways of giving the drug under the skin – specifically, pre-filled syringes and auto-injectors, and different sizes of these – deliver the medication in the same way. We also want to make sure these devices are safe and well-tolerated by patients. Understanding this will help ensure that people with these conditions can receive their treatment effectively and conveniently in the future. This is a Phase 2 study, meaning it's still in the earlier stages of drug development.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

155

Start

02 Jul 2024

Estimated completion

16 Jan 2029

Sjögrens Disease Systemic Lupus Erythematosus Rheumatoid Arthritis

What is this study about?

This study is about a medication called ianalumab, which is being investigated for managing autoimmune diseases like Sjögren's disease, systemic lupus erythematosus (often called lupus), and rheumatoid arthritis. In these conditions, your immune system mistakenly attacks your own body. Ianalumab is designed to help control this.

The main purpose of this study is to compare different ways of giving ianalumab. Specifically, we're looking at giving the drug through a pre-filled syringe versus an auto-injector. Auto-injectors are often easier for patients to use at home. We also want to check if giving one larger injection or two smaller injections delivers the medicine to your body in the same way. It's really important that these different methods give you the right amount of medicine.

By ensuring these devices deliver the medication consistently and are safe, this study aims to make future treatment options for these autoimmune conditions as effective and user-friendly as possible. This research is a key step in developing better ways for patients to manage their conditions.

Key takeaways

This study is testing a drug called ianalumab for autoimmune diseases like lupus, Sjögren's, and rheumatoid arthritis.
The main goal is to compare different ways of injecting the medicine (syringes vs. auto-injectors).
It's a Phase 2 study focused on safety and how the drug is absorbed by the body.
Participation could last up to 1.5 years, involving monthly injections and regular check-ups.
You will switch between different injection devices during the study.
Your standard care for your condition will continue alongside the study treatment.

Who may be eligible?

This study is looking for adults aged 18 to 70 years old who have been diagnosed with rheumatoid arthritis, Sjögren's disease, or systemic lupus erythematosus. Your doctor must agree that your disease is active and could benefit from this type of treatment.

You also need to be within a certain weight range (at least 35 kg and up to 150 kg) and have a body mass index (BMI) between 18 and 35. If you're taking other medications for your condition, they need to have been at a steady dose for at least four weeks before you start the study. You must also be able to understand what the study involves and agree to follow the study rules.

Some reasons you wouldn't be able to join include if you have active infections, serious uncontrolled health problems, or are pregnant or breastfeeding. Women who could become pregnant and men who are sexually active with women who could become pregnant will need to use effective birth control throughout the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have a diagnosis of rheumatoid arthritis, Sjögren's disease, or lupus?
Is your doctor able to confirm your disease is active and could benefit from this treatment?
Are you able to use suitable birth control if you are a woman who could become pregnant, or a sexually active man with a partner who could become pregnant?
Do you have any infections, serious uncontrolled health issues, or are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a 'screening period' lasting up to 4 weeks. During this time, you'll have checks to see if you're suitable for the study. If you qualify, you'll enter the 'treatment period' which lasts for 24 weeks.

During this time, you'll receive monthly injections of ianalumab. You'll be randomly assigned to one of two groups. In one group, you'll use one type of injection device for the first 12 weeks, then switch to another type for the next 12 weeks. In the other group, you'll use those devices in the opposite order. We'll also be looking at different injection sites on your body. You'll continue with your usual standard treatment for your condition alongside the study medication.

After these 24 weeks, you might have the option to join an 'extended treatment period' for another year, where you'll continue to receive ianalumab monthly. The study will involve regular visits for assessments and blood tests. The total time you could be involved in the study, including follow-up after your last treatment, could be up to 72 weeks (about 1.5 years).

Potential risks and benefits

Taking part in a clinical study could offer potential benefits, such as access to a new medication before it's widely available and closer monitoring of your health by medical professionals. However, there are also potential risks, including side effects from the medication or discomfort from injections and study procedures. The study is designed to carefully monitor your safety throughout. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

Pinnacle Research Group Llc
Verified postcode
Anniston, United States
Providence Medical Foundation
Verified postcode
Fullerton, United States
Advanced Medical Research
Verified postcode
La Palma, United States
Conquest Research
Verified postcode
Winter Park, United States
Parris and Associates Rheumatology
Verified postcode
Lawrenceville, United States
Indiana Univ School of Dentistry
Verified postcode
Indianapolis, United States
Ochsner Health System
Verified postcode
Baton Rouge, United States
Ahmed Arif Medical Research Center
Verified postcode
Grand Blanc, United States
Paramount Med Rsrch and Consult LLC
Verified postcode
Middleburg Heights, United States
RAO Research LLC
Verified postcode
Oklahoma City, United States
Altoona Center for Clin Res
Verified postcode
Duncansville, United States
West Tennessee Research Institute
Verified postcode
Jackson, United States

Common questions

What is an autoimmune disease?

An autoimmune disease is when your body's immune system mistakenly attacks your own healthy tissues, causing inflammation and damage.

What is ianalumab?

Ianalumab is the name of the drug being studied in this trial. It's a type of medication aimed at treating autoimmune conditions.

What are pre-filled syringes and auto-injectors?

These are different devices used to give medicines by injection under the skin. An auto-injector is often a pen-like device that makes self-injection easier.

What does 'Phase 2' mean for a study?

Phase 2 means the drug is still being tested. It's primarily checking how well the drug works and its safety in a larger group of people than in earlier studies.

Will I know which injection device I'm using?

Yes, in this study, you will know which device you are using during each part of the treatment period.