Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ARGX-113-2211: Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients with primary Sjögren’s Syndrome (pSS) who complete qualifying efgartigimod pSS studies

This research is an open-label extension study exploring the safety of a new medicine, efgartigimod, for adults with primary Sjögren's Syndrome (pSS). This means that both the patients and the doctors will know they are receiving the study medicine. The study will look closely at any side effects, how severe they are, and any serious health issues that might come up. Researchers will also check changes in blood tests, blood pressure, heart rhythm, and other measures to get a full picture of how the medicine affects the body. This study is for people who have already completed a previous study on efgartigimod for pSS.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Argenx

Enrolment target

Start

25 Sep 2023

Primary Sjögren's Syndrome

What is this study about?

This clinical trial is designed to learn more about a new medicine called efgartigimod for people living with primary Sjögren's Syndrome (pSS). Sjögren's Syndrome is a long-term condition that affects parts of the body that produce fluids, like tears and saliva, leading to dryness and sometimes affecting other organs. Medicines like efgartigimod are being developed to help manage the symptoms and effects of pSS.

This particular study is what's called an "open-label extension." This means that people taking part, as well as their doctors, will know they are receiving the study medicine, efgartigimod – there are no placebos in this specific part of the research. It's for people who have already finished a previous study with efgartigimod for their pSS, and it aims to gather more information about the medicine's safety over a longer period.

The main goal is to carefully track any side effects that might happen, how serious they are, and any other changes in health, such as blood test results or heart readings. Researchers will also look at whether the medicine helps improve symptoms or reduce disease activity in pSS, using different ways to measure how people feel and how the disease is affecting them. This helps doctors understand if the medicine is safe and if it could be a helpful treatment option in the future.

Key takeaways

This study is testing a new medicine called efgartigimod for primary Sjögren's Syndrome.
It's an extension study for people who have already taken part in a previous efgartigimod trial.
The main focus is to understand the safety and any side effects of the medicine.
You'll have regular check-ups, blood tests, and heart monitoring.
Your participation will last for about 48 weeks.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you must be an adult aged 18 or older. It is open to both men and women.

Crucially, you must have previously participated in and completed a qualifying study looking into efgartigimod for primary Sjögren's Syndrome. This study is designed as a follow-up for those previous participants.

Your study doctor will discuss all the specific requirements with you to make sure this is the right study for you to join.

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?
Have you already completed another study with efgartigimod for Sjögren's Syndrome?
Are you able to attend regular clinic visits for about a year?
Do you want to learn more about a potential new treatment for Sjögren's Syndrome?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study medicine, efgartigimod. You will have regular visits to the clinic where the study team will carry out various checks. These will include blood tests, monitoring your vital signs (like blood pressure and heart rate), and performing heart rhythm checks (ECGs). They will also ask you about any side effects you might be experiencing. The study will track your health and how the medicine is affecting your Sjögren's Syndrome for a total of 48 weeks, which is nearly one year.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit could be access to a new medicine that might help manage your Sjögren's Syndrome. However, as with any medicine, efgartigimod may cause side effects, some of which could be serious. The study team will explain these to you fully before you decide to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Poland
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Unverified
Hungary
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Unverified
Belgium

Common questions

What is primary Sjögren's Syndrome?

It's a long-term immune system condition that causes dryness in parts of the body, especially eyes and mouth, and can affect other organs.

What does 'open-label' mean?

It means both you and your doctor will know you are receiving the study medicine, efgartigimod. There is no placebo in this part of the study.

How long will I be in the study?

The study treatment period and follow-up will last for 48 weeks, which is just under a year.

Will this medicine cure my Sjögren's Syndrome?

This is a research study to assess the safety and potential effects of a new medicine. It's not aiming for a cure, but rather to find ways to better manage the condition.

Do I have to pay to participate?

No, you will not have to pay to take part in the study. All study-related care and medicine will be provided.