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 Ulcerative Colitis

This study is looking at a new medicine, Duvakitug, for adults who have ulcerative colitis that is moderately to severely active. The main goal is to find out if Duvakitug can help people stay in remission, meaning their symptoms are well-controlled, over a longer period. Participants will be randomly given either Duvakitug or a dummy medicine (placebo) without knowing which one they receive. Researchers will check for improvements in gut healing, how often people need to use the toilet, stomach pain, and general well-being, to see how well Duvakitug works and if it's safe to use. This information will help doctors understand if Duvakitug could be a useful long-term treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

209

Start

09 Feb 2026

Immune system diseases

What is this study about?

This research study is focused on people who have ulcerative colitis, a long-term condition that causes inflammation in the large intestine. When ulcerative colitis is "moderately to severely active," it means symptoms like belly pain, frequent trips to the toilet, and bleeding are significantly affecting daily life. The new medicine being tested in this study is called Duvakitug, and it's designed to help manage these symptoms and hopefully prevent them from returning.

The study is called a "Phase 3" trial, which means it's one of the final stages of testing a new medicine before it can potentially be made available to everyone. It's also a "maintenance study," which means it's looking at whether Duvakitug can help people stay well once their initial symptoms have improved. Researchers want to know if Duvakitug can keep the disease in remission, meaning symptoms are under control, for a longer time.

To get clear results, some participants will receive Duvakitug, and others will receive a "placebo" – which looks exactly like the study medicine but contains no active drug. Neither the participants nor the doctors will know who is getting which, to ensure the results are fair. The main thing they'll be looking for is how many people achieve and maintain clinical remission, which means a significant reduction in their symptoms. They will also look at how the gut lining heals, how tired people feel, and their overall quality of life to get a full picture of the medicine's effects.

Key takeaways

This study is testing a new medicine called Duvakitug for ulcerative colitis.
It aims to see if Duvakitug can help people stay in remission (symptom-free) for longer.
Participants will receive either Duvakitug or a dummy medicine (placebo).
It's a Phase 3 study, meaning it's a key step towards potential future widespread use.
The study will track symptoms, gut healing, and overall well-being and safety.
Taking part means regular clinic visits and assessments.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with ulcerative colitis. To join, your ulcerative colitis must be considered moderately to severely active – meaning you're experiencing noticeable symptoms.

There might be other health conditions or medicines you're taking that could prevent you from taking part, to ensure your safety and the accuracy of the study results. The research team will review your full medical history carefully to make sure the study is a good fit for you.

It's important to have an open conversation with your doctor and the study team to understand all the specific requirements and to see if you meet the criteria for joining.

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 ulcerative colitis?
Is your ulcerative colitis currently causing moderate to severe symptoms?
Are you willing to attend regular clinic appointments and undergo medical tests?
Are you prepared to potentially receive a dummy medicine instead of the active drug?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to receive either the new medicine, Duvakitug, or a dummy medicine (placebo). Neither you nor your study doctor will know which one you're getting. You'll take the study medicine regularly according to the instructions.

Throughout the study, you'll have several scheduled visits to the clinic. These visits will involve various assessments, such as physical examinations, blood tests, and sometimes stool tests. You might also have endoscopies (a procedure to look inside your colon) to check how your gut is healing. You'll be asked to answer questionnaires about your symptoms, how you're feeling, and your quality of life. The study will last for a certain period, and even after you stop taking the study medication, there will likely be follow-up visits to monitor your health. All these steps help the researchers understand how well the medicine works and if it's safe.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might feel better if the study medicine, Duvakitug, works for you, and you'll be contributing to scientific knowledge that could help future patients. However, there's always a chance you could experience side effects from the study medicine, or that it might not improve your condition. The dummy medicine (placebo) won't have any medical effect on your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Slovakia
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Unverified
Germany
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Unverified
Austria
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Unverified
Italy
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Unverified
Czechia
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Unverified
Netherlands
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Unverified
Poland
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Unverified
Belgium
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Unverified
Hungary
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Unverified
Lithuania
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Unverified
Greece
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Unverified
France

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny ulcers. This causes symptoms like diarrhoea, belly pain, and blood in your poo.

What does 'remission' mean in this study?

In this study, 'remission' means that your ulcerative colitis symptoms are significantly reduced or have gone away, and there are also signs of healing in your colon.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the active study medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving Duvakitug or the placebo. This helps ensure unbiased results.

How long will I need to be in the study?

The study has a set duration, but the exact total duration for each participant, including follow-up, will be explained in detail by the study team before you decide to join.