AuthorisedTherapeutic exploratory (Phase II)Interventional

Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial

This study, called DUCT, is for people newly diagnosed with ulcerative colitis, a long-term condition that causes inflammation in the large intestine. Researchers want to see if starting treatment with a specific medication, called Amgevita, early on can lead to better outcomes. They will be looking at whether patients achieve a 'deep remission' – meaning their symptoms are minimal, their gut lining looks healthy, and they have improved inflammatory markers – one year after their diagnosis. The study also aims to understand how many people need stronger treatments or surgery within that first year. Participants will be followed for three years to assess their health, quality of life, and treatment costs.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitetssykehuset Nord-Norge HF

Enrolment target

200

Start

19 Jun 2025

Ulcerative colitis

What is this study about?

Ulcerative colitis is a condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo. Living with ulcerative colitis can be challenging, and finding the right treatment is very important for managing symptoms and improving your quality of life.

This particular study, known as the DUCT trial, is designed for people who have recently been diagnosed with ulcerative colitis. The main idea behind the study is to explore if a specific treatment approach, sometimes called a 'top-down' strategy, could be more effective. This means giving a powerful medication, Amgevita, earlier in the disease course, rather than waiting for other treatments to fail.

The researchers want to see if this early treatment helps people go into 'deep remission.' This isn't just about feeling better; it means that your symptoms are largely gone, your bowels look healthy on examination, and your body's inflammation levels are low. They'll be checking these things one year after your diagnosis. The study also wants to see if this early treatment can help people avoid needing more intensive treatments, like other strong medications or even surgery, in the first year. They will also look at how this treatment affects your quality of life and healthcare costs over three years.

Key takeaways

This study is for newly diagnosed adults with ulcerative colitis.
It tests starting a specific drug (Amgevita) early on.
The main goal is to achieve 'deep remission' and avoid surgery/stronger drugs in the first year.
Participation involves injections, clinic visits, and health tracking for three years.
It aims to improve long-term outcomes and quality of life for patients.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit for taking part.

This study is for both men and women.

Importantly, this study focuses on people who have recently been diagnosed with ulcerative colitis.

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 recently been diagnosed with ulcerative colitis?
Are you comfortable with self-injecting medication (or having a caregiver do so)?
Are you able to attend regular clinic appointments for three years?

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, Amgevita, which is given as an injection using a pre-filled pen. You would typically learn how to give this injection to yourself at home. You would have several visits to the study clinic over the first year to monitor your progress, and then less frequently for two more years, making a total of three years of follow-up. During these visits, you'll have check-ups, answer questions about how you're feeling and your quality of life, and likely have some blood tests and possibly other procedures like a colonoscopy to check the health of your bowel. Researchers will also ask about your medical expenses related to your condition.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment approach that could lead to better control of your ulcerative colitis. However, there are also potential risks; Amgevita, like all medications, can have side effects, which your doctor will discuss with you. You might also need to attend more appointments than usual. Your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
Norway

Common questions

What is ulcerative colitis?

It's a long-term condition that causes inflammation and sores in the lining of your large bowel, leading to symptoms like stomach pain and diarrhoea.

What is 'deep remission'?

It means your ulcerative colitis symptoms are very mild or gone, your gut looks healthy inside, and inflammation in your body is low.

What is Amgevita?

Amgevita is a type of medication called a biologic that helps reduce inflammation in conditions like ulcerative colitis. It's given as an injection.

How long does the study last?

If you join, you'll be involved in the study for a total of three years, with more frequent checks in the first year.

Who is paying for this study?

The information provided doesn't specify the funding source, but clinical trials are typically funded by pharmaceutical companies, government agencies, or research organisations.