AuthorisedTherapeutic confirmatory (Phase III)Interventional

A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease

This important study is investigating a new medication, duvakitug, for individuals living with moderate to severe Crohn's disease. Crohn's is a long-lasting condition where your immune system mistakenly attacks your gut, causing inflammation and discomfort. This study, called a 'Phase 3' trial, is designed to see if duvakitug can effectively manage the disease and reduce symptoms over a longer period. Half of the participants will receive duvakitug, while the other half will get a placebo (a dummy treatment, like a sugar pill), without anyone knowing who gets what until the study ends. This helps researchers accurately compare duvakitug's effects. They will be looking at how many people achieve a significant improvement in their symptoms and how the gut looks internally.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

204

Start

24 Feb 2026

Immune system diseases

What is this study about?

This study is a research project for a new medicine called duvakitug. It's for people who have Crohn's disease that is moderate to severe, meaning it significantly affects their daily lives. Crohn's disease is a condition where your immune system mistakenly attacks parts of your digestive system, leading to inflammation, pain, and other symptoms. The main goal of this study is to find out if duvakitug can help keep Crohn's disease under control over time and if it is safe for patients to use.

This kind of study is called a 'Phase 3' trial. This is usually the last step before a medicine might be approved for wider use. Because it's a 'randomized, double-blind, placebo-controlled' study, it means a few key things. 'Randomized' means that participants are put into groups by chance – like flipping a coin – to get either duvakitug or a 'placebo.' A placebo looks just like the real medicine but has no active ingredients. 'Double-blind' means that neither the patients nor their doctors will know whether they are getting the new medicine or the placebo. This helps ensure the results are as fair and unbiased as possible.

Researchers will be carefully checking how well duvakitug works by looking for improvements in symptoms, like how often and how severely people experience pain or digestive issues. They will also use special tests, like examining the inside of the gut, to see if the inflammation has reduced. They will also monitor for any side effects to understand the safety of the medicine. This study is happening in many different hospitals and countries to gather a lot of information from a diverse group of people.

Key takeaways

This study is testing a new medicine called duvakitug for moderate to severe Crohn's disease.
It's a Phase 3 study, meaning it's a key step in seeing if the medicine can become widely available.
Participants will either receive duvakitug or a placebo, and no one involved will know which.
The study will last about 40 weeks and involve regular clinic visits and health checks.
Researchers want to see if the medicine improves symptoms and reduces inflammation in the gut.
You can stop participating in the study at any time, for any reason.

Who may be eligible?

To join this study, you must be at least 18 years old. People of all genders can take part.

More detailed requirements would be discussed with you by the study team. These usually include having a confirmed diagnosis of Crohn's disease that is currently active and moderately to severely affecting you. Participants would also need to meet specific health criteria, possibly related to their liver, kidney, or other organ function, to ensure it's safe for them to take part.

There might also be certain medications you can't be taking, or other health conditions that would prevent you from joining. The study team will review your full medical history to confirm if this study is a good fit for you.

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 a diagnosis of Crohn's disease?
Is your Crohn's disease currently active and bothering you a lot?
Are you able to attend regular clinic appointments for about 9-10 months?
Are you willing to potentially receive a placebo instead of the new medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication (either duvakitug or the placebo) regularly over a period of about 40 weeks, which is roughly 9 to 10 months. You would have planned visits to the study clinic where the research team would do various health checks. These visits would include physical exams, blood tests, and possibly questionnaires about your symptoms to see how you are feeling.

The researchers will also conduct special procedures to look at the inside of your gut, like an endoscopy, to understand how the medication is affecting the inflammation. You might need to have these tests at the beginning of the study and again around Week 40. You will be carefully monitored throughout the study for any changes in your health. The medical team will provide detailed information about what each visit involves and how long it typically takes.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as receiving a new investigational treatment for your Crohn's disease and close medical monitoring. However, there are also potential risks; the new medicine might not work for you, or you could experience side effects. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

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

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Unverified
Spain
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Unverified
Czechia
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Unverified
Lithuania
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Unverified
Hungary
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Unverified
Greece
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Belgium
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Unverified
France
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Unverified
Germany
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Unverified
Norway
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Unverified
Austria

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition where parts of your digestive system become inflamed and swollen. This can cause symptoms like tummy pain, diarrhoea, and weight loss.

What does 'double-blind' mean in a study?

It means that neither you nor your study doctor will know if you are receiving the new medicine or a dummy treatment (placebo). This helps make the study results fair.

Will I get paid to be in the study?

Clinical trials generally do not pay participants for their time, but sometimes they cover travel costs. You should ask the study team about this.

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real medicine but has no active ingredients. It's used so researchers can compare its effects to the new medicine.

What if I get worse during the study?

Your health will be closely monitored. If your condition worsens, the study team will provide appropriate medical care and discuss your options, including stopping the study drug if necessary.