AuthorisedTherapeutic use (Phase IV)Interventional

OPTIMAL CARE WITH GUSELKUMAB IN CROHN’S DISEASE

This study, named OPTIMAL CARE WITH GUSELKUMAB IN CROHN’S DISEASE, is looking into how effective a medicine called guselkumab is for treating Crohn's disease. The main goal is to find out if guselkumab can help people with Crohn's disease achieve a state where their symptoms are well-controlled without needing steroid medications, and if it can also significantly lower a specific marker of gut inflammation (called fecal calprotectin) after 48 weeks. This is a Phase IV study, meaning the medicine is already approved, and researchers are gathering more information about its use in real-world settings to improve patient care.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

i-GETAID

Enrolment target

210

Start

16 Apr 2026

Crohn's disease

What is this study about?

This research study is focusing on Crohn's disease, a long-term condition that causes inflammation in the digestive system. The study is called OPTIMAL CARE WITH GUSELKUMAB IN CROHN’S DISEASE and it's looking at a specific medication called guselkumab, which is given as an injection. The main purpose is to see how well guselkumab works for people living with Crohn's disease and if it can help them get better and stay better without needing to take steroid medications, which can have side effects.

The researchers will be monitoring a few things to check how well the treatment is working. The most important measure is whether patients achieve 'steroid-free clinical remission.' This means their Crohn's disease symptoms are under control, and they haven't needed steroids for a certain period. They also want to see if a specific marker in stool, called fecal calprotectin, goes down to a low level, as this shows that inflammation in the gut is reduced. These checks will happen 48 weeks after starting the treatment.

Beyond the main goal, the study will also look at other important aspects. This includes checking if the gut lining looks healthier (called 'morphological remission') using tools like endoscopy or MRI, seeing how quickly people go into remission (at 12 and 24 weeks), and how their overall quality of life improves. All these measures help the researchers understand the full impact of guselkumab on people with Crohn's disease.

Key takeaways

This study evaluates guselkumab for Crohn's disease.
It aims for symptom control and reduced inflammation without steroids.
The main goal is to measure improvement after 48 weeks.
It's open to adults aged 18 and over.
Participation involves regular clinic visits and assessments.
It's a Phase IV study, often focusing on real-world treatment benefits.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, so adults of any age are welcome to be considered.

The study is open to both men and women, as well as anyone who doesn't identify with those categories. The researchers want to understand how guselkumab works across all adults.

Specific details about your health and your Crohn's disease, such as how severe it is or what other treatments you might have tried, will be carefully reviewed by the study doctors. They will make sure the study is a good fit for you and that taking part would be safe and appropriate.

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 Crohn's disease?
Are you able to attend regular appointments for about a year?
Are you comfortable with injections for medication?
Are you willing to provide blood and stool samples?

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, guselkumab, as an injection. You will have regular appointments with the study team over a period of 48 weeks, which is about 11 months. These appointments will involve various assessments, such as physical examinations, blood tests, and stool samples to check your inflammation levels (fecal calprotectin).

Additionally, some participants might have imaging tests like MRI or specialized scopes (endoscopy) to look at your digestive system, depending on what tests were used when you first joined the study. You will also be asked to fill out questionnaires to measure your quality of life. After the 48 weeks, there might be follow-up checks to see how you're doing. The study team will explain the full schedule of visits and what each involves in detail.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new treatment for your Crohn's disease under close medical supervision and contributing to medical knowledge that could help others. However, like all medications, guselkumab can have side effects, and these will be fully explained to you before you agree to participate. There's also no guarantee that the treatment will work for everyone. You have the right to withdraw from the study at any time, for any reason, without affecting your usual 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 Crohn's disease?

Crohn's disease is a type of inflammatory bowel disease (IBD) that causes long-lasting inflammation in your digestive tract, which can lead to symptoms like stomach pain, severe diarrhoea, tiredness, and weight loss.

What is guselkumab?

Guselkumab is a medication given by injection that helps to reduce inflammation in the body. It works by targeting a specific protein involved in the immune response.

What does 'steroid-free clinical remission' mean?

This means your Crohn's disease symptoms are under control, and you haven't needed to take steroid medications, which can have various side effects, to manage your condition.

What is fecal calprotectin?

Fecal calprotectin is a substance measured in your stool. Higher levels can indicate inflammation in your gut, so lower levels suggest your Crohn's disease is more stable.

Is this a new medicine not yet available?

No, this is a Phase IV study, meaning guselkumab is already an approved medicine. This study aims to gather more information about its effectiveness and use in a broader group of patients.