Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study evaluating the safety, tolerability, and efficacy of GLPG5101 in adults with treatment-refractory active systemic lupus erythematosus

This research study is about a new medicine, GLPG5101, designed for adults who have a specific type of lupus called systemic lupus erythematosus. This type of lupus is considered 'active' and 'treatment-refractory', meaning it hasn't improved with standard treatments. The main goals of this study are to see if GLPG5101 is safe to use and if people taking it experience any uncomfortable side effects (this is called 'tolerability'). We also want to find out if this new medicine can help improve the symptoms of lupus for these patients. This is one of the earliest stages of testing a new medicine in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Galapagos

Enrolment target

Start

02 Oct 2023

Treatment-refractory active systemic lupus erythematosus

What is this study about?

Lupus is a long-term condition that causes the body's immune system to mistakenly attack its own tissues and organs. This can lead to inflammation and damage in many different parts of the body, such as the joints, skin, kidneys, brain, heart, and lungs. When lupus is 'active', it means symptoms are currently flaring up. Some people with lupus find that their condition doesn't get better with the usual treatments; this is what we mean by 'treatment-refractory'.

This study is looking at a new medicine called GLPG5101. The aim is to understand if this medicine could be a helpful new option for adults who are struggling with active lupus that hasn't responded to other medicines. By taking part, volunteers will help us learn more about this potential treatment.

This is an early-stage study, which means it's one of the first times this medicine is being tested in people. This phase primarily focuses on safety and how the body handles the medicine, rather than its full effects. The information gathered from studies like this is really important for developing new and better ways to treat conditions like lupus in the future.

Key takeaways

Tests a new medicine (GLPG5101) for lupus.
For adults (18+) with active lupus that hasn't responded to other treatments.
Main goals are to check safety, tolerability, and early signs of effectiveness.
It's an early-stage study (Phase I).
Participation involves regular clinic visits for checks and medicine.
You can stop participating at any time.

Who may be eligible?

To join this study, participants must be adults, aged 18 or older. The study is open to both men and women.

The main requirement for joining is that you must have systemic lupus erythematosus that is currently active and hasn't improved with other treatments you've tried. The doctors involved in the study will check if your current lupus condition matches what they are looking for.

There will be other health checks and criteria that the study team will discuss with you to make sure it's safe and appropriate 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 systemic lupus erythematosus?
Is your lupus currently active (having symptoms)?
Have you tried other lupus treatments that haven't fully helped?
Are you able to attend regular appointments at a study clinic?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you will be given the new medicine, GLPG5101. You would need to attend several appointments at the study clinic for health checks, blood tests, and to receive the medication. These visits will help the doctors monitor your health, see how you are reacting to the medicine, and check for any changes in your lupus symptoms or potential side effects.

The study team will explain exactly how often you'll need to visit and how long each visit might be. They will also tell you about the specific tests involved. The total duration of your involvement in the study, including follow-up, will be clearly explained before you decide to join.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as receiving a new medicine that might help your lupus symptoms, and receiving close medical attention from a specialist team. However, there are also potential risks, as GLPG5101 is a new medicine and its full effects, including side effects, are not yet completely known. You will be closely monitored for any unwanted effects. Remember, joining a study is always your choice, and you are free to withdraw at any time without giving a reason, and this decision will not affect your usual medical care.

Locations (2)

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

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Unverified
Netherlands
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Unverified
Belgium

Common questions

What is 'treatment-refractory active systemic lupus erythematosus'?

This means you have a type of lupus that is currently flaring up, and standard medicines haven't helped to control it well enough.

What is GLPG5101?

It's a new medicine being tested to see if it can help adults with persistent lupus.

What does a 'Phase I' study mean?

It means this is one of the first times the medicine is being tested in people. The main focus is on safety and how the body handles the medicine.

Will I definitely get the new medicine?

In this type of study, all participants usually receive the new medicine. The study team will confirm this with you.

How long will I be in the study?

The study team will tell you the exact length of your participation, including any follow-up visits, before you join.