Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Study to Evaluate the Safety and Target Engagement of EXL01 in the Maintenance of Steroid-induced Clinical Response or Remission in Patients with Mild to Moderate Crohn's Disease

This is an early human study (Phase 1) exploring a new drug, EXL01, for individuals who have mild to moderate Crohn's disease. The main goal is to check how safe EXL01 is when given to people for the first time. Researchers also want to see if the medicine reaches and affects the right target in the body. The hope is that EXL01 could help people maintain their good health, or 'remission,' after their symptoms have improved using standard steroid treatments. This study is an important first step in understanding if EXL01 could be a helpful treatment option in the future for managing Crohn's disease.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Exeliom Biosciences

Enrolment target

Start

07 Aug 2023

Crohn's Disease

What is this study about?

This study is about a new medicine called EXL01, which is being tested for people who have Crohn's disease. Crohn's disease is a long-term condition that causes inflammation in the digestive system, leading to symptoms like tummy pain, diarrhoea, and tiredness. Sometimes, doctors prescribe medicines called steroids to help calm down these symptoms and make people feel better. This study is looking at whether EXL01 can help people stay well after their Crohn's symptoms have improved with steroid treatment.

This is a very early study, called a Phase 1 study. This means it's one of the first times this new medicine, EXL01, is being given to people. The main thing the researchers want to find out is whether EXL01 is safe to use. They will be very carefully watching for any side effects or problems that might happen. They also want to check if the medicine gets to the right place in the body and does what it's supposed to do at a basic level – this is called 'target engagement'.

The aim is to see if EXL01 has the potential to help people with mild to moderate Crohn's disease keep their condition under control, without their symptoms flaring up again after they've responded well to steroids. If this early study shows EXL01 is safe and works in the way they expect, it could then move on to bigger studies to see if it truly helps manage Crohn's disease long-term.

Key takeaways

This study tests a new medicine called EXL01 for Crohn's disease.
It's a very early-stage study focusing on safety.
Aims to help people with mild to moderate Crohn's stay well after steroid treatment.
Open to adults aged 18 and over.
Requires regular clinic visits for monitoring.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to everyone, whether you are male or female.

The study is specifically looking for people who have mild to moderate Crohn's disease. This means your disease isn't too severe at the moment, but you're still experiencing symptoms or have recently been treated for them. A key part of joining is that you must have responded well to steroid treatment, and the study will look at helping you maintain that good response.

The medical team will carefully check your health history and do some tests to make sure that taking part in this study is safe and appropriate for you. They will explain all the specific requirements in detail.

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 been diagnosed with mild to moderate Crohn's disease?
Have your Crohn's symptoms improved after taking steroid medication?
Are you willing and able to attend regular clinic visits for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study medicine, EXL01. Because this is a very early-stage study, you would have regular visits to the clinic so the research team can closely monitor your health and how you react to the medicine. These visits would involve health checks, blood tests, and perhaps other assessments to make sure you are safe and to understand how the medicine is working in your body. We don't have details on the exact number of visits or the total length of the study from the information provided, but typically, early-stage studies involve frequent check-ups and a certain period of taking the medicine, followed by a time where they keep checking on you even after you stop the medicine.

Potential risks and benefits

Participating in this study might offer you the chance to receive a new medication for your Crohn's disease that isn't yet widely available, and you would be closely monitored by medical professionals. However, as this is a new medicine, there might be side effects or risks that are not yet fully understood. There's no guarantee that the medicine will improve your condition, and it might not work for everyone. You have the right to withdraw from the study at any time and for any reason, without it affecting 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
Belgium
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Unverified
Poland

Common questions

What is Crohn's disease?

Crohn's disease is a condition that causes inflammation in the digestive system, leading to tummy pain, diarrhoea, and other symptoms.

What is a Phase 1 study?

A Phase 1 study is an early research stage where a new medicine is given to people for the very first time, mainly to check if it's safe.

What does 'steroid-induced clinical response or remission' mean?

It means your Crohn's symptoms have improved or gone away after you have been treated with steroid medicines.

Will I stop my current medicines if I join?

The study team will discuss all your current medicines with you and explain which ones you might need to stop or change if you participate.

Will I know if I'm getting the new medicine or something else?

In some studies, people know, but in others, you might not know if you're getting the active medicine or a dummy treatment (placebo). The study team will explain how this works.