Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An open-label, non-randomized, biopsy-based mechanistic study on pharmacokinetics, pharmacodynamics, safety and tolerability of ianalumab in patients with Sjögren's syndrome

This study is exploring a new medication, ianalumab, for people with Sjögren's syndrome. Sjögren's syndrome is a condition that often causes dry eyes and mouth. Researchers want to understand how ianalumab works in the body and specifically how it affects certain cells in the salivary glands, which are important for producing spit. The study will also carefully check for any side effects and how well people tolerate the treatment. This is a "Phase II" study, which means it's an early step to gather more information about a potential new medicine after initial safety tests. The main goal is to see if ianalumab can change the balance of certain immune cells in the salivary glands.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Novartis Pharma AG

Enrolment target

Start

22 Mar 2024

Sjögren's syndrome

What is this study about?

This study is looking into a new treatment called ianalumab for a condition called Sjögren's syndrome. If you have Sjögren's syndrome, your immune system mistakenly attacks healthy parts of your body, often leading to very dry eyes and mouth. This can be uncomfortable and affect your daily life.

The researchers want to understand how this new medicine works. Specifically, they will be taking small tissue samples (biopsies) from the salivary glands to see how ianalumab affects certain immune cells called B cells and T cells. They will also be studying how the body processes the medicine, which is called pharmacokinetics, and how the medicine affects the body, known as pharmacodynamics.

This study is in an early stage (Phase II), which means it's designed to get a better understanding of the medicine's effects, safety, and how it's handled by the body, rather than confirming its effectiveness in a large group of people. The information gathered here will help decide if this medicine should be studied further.

Key takeaways

This study is for people with Sjögren's syndrome.
It's testing a new medicine called ianalumab.
The main goal is to see how the medicine affects salivary glands and its safety.
It's an early-stage study (Phase II).
Participation involves clinic visits, taking the medicine, and tissue samples.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. There is no upper age limit, meaning older adults are also welcome to participate if they meet other health criteria.

Both men and women can take part in this research. The study is open to anyone over 18, regardless of their gender.

Specific health conditions or medications might prevent someone from joining, but these will be discussed in detail by the study team to make sure it's safe for you to participate.

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 18 years old or older?
Do you have Sjögren's syndrome?
Are you able to attend appointments regularly?
Are you comfortable with having small tissue samples (biopsies) taken from your salivary glands?
Are you willing to take an experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, ianalumab, for a period of time. The study is designed to be "open-label," which means both you and the study team will know you are receiving ianalumab. You will have regular visits to the clinic where the study team will monitor your health, take blood samples, and perform examinations, including checking your salivary glands. You will also have follow-up visits after you finish taking the medication to ensure you remain well and to track any lasting effects. The total duration of your participation, including treatment and follow-up, will be explained fully by the study team, but it will involve multiple clinic visits over several months.

Potential risks and benefits

Taking part in this study could offer a potential benefit by giving you access to a new experimental treatment for Sjögren's syndrome that isn't yet widely available. However, as with any new medicine, there are potential risks, including side effects that are not yet fully known. The study team will monitor you closely for any adverse reactions. You will be given a complete list of known and potential risks before you decide to join. 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 medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Sjögren's syndrome?

Sjögren's syndrome is a long-term condition where your immune system mistakenly attacks parts of your body, often causing very dry eyes and mouth, and sometimes affecting other organs.

What is ianalumab?

Ianalumab is a new medicine being tested in this study to see if it can help people with Sjögren's syndrome. It's not yet approved for general use.

What does 'Phase II study' mean?

A Phase II study is an early stage of research where doctors learn more about the safety of a new medicine, how it works in the body, and what its effects might be, in a relatively small group of people.

Will I know if I'm getting the active medicine?

Yes, this is an 'open-label' study, which means both you and the study doctors will know you are receiving ianalumab, not a placebo.

Will I have to have a biopsy?

Yes, this particular study involves taking small tissue samples (biopsies) from your salivary glands to understand how the medicine affects them. The study team will explain this procedure in detail.