Active not recruitingPHASE2INTERVENTIONAL

Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy

This research study is looking into a new treatment, AZD7798, for people living with Crohn's disease who have an ileostomy. The main goals are to understand if the medication is safe, how well people tolerate it, and if it can help heal the lining of the gut. Participants will receive either AZD7798 or a placebo (a dummy drug) for 12 weeks without knowing which one they are getting. After this, all eligible participants will receive the active drug for a longer period. This study aims to find new ways to manage Crohn's disease for those with an ileostomy, specifically focusing on healing the gut.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

Start

11 Dec 2024

Estimated completion

03 Sep 2027

Crohn's Disease

What is this study about?

Crohn's disease is a long-term condition that causes inflammation in your digestive system. Sometimes, people with Crohn's disease may need surgery to remove a part of their bowel and have an ileostomy, where a small opening is made in the tummy to collect waste. Even after this surgery, inflammation can sometimes return in the remaining part of the small bowel, close to the ileostomy.

This study is testing a new medication called AZD7798. We want to see if this new drug can help reduce inflammation and heal the lining of the gut in people with Crohn's disease who have an ileostomy and still have active inflammation. By understanding how AZD7798 works and if it's safe, we hope to find better ways to manage Crohn's disease.

Participants in this study will be randomly assigned to receive either AZD7798 or a placebo (a dummy drug that looks like the active medicine but contains no active ingredients). This is a 'blinded' study, meaning neither you nor your study doctor will know which treatment you are receiving at first. This helps us get unbiased results about the true effect of the medication. The study will look at how your body reacts to the medication and if it helps to heal the gut.

Key takeaways

Tests new drug AZD7798 for Crohn's disease with ileostomy.
Compares AZD7798 to a placebo (dummy drug) for safety and gut healing.
Involves 12 weeks of initial treatment, then 40 weeks of active treatment for all eligible participants.
Study is 'blinded' initially, meaning you won't know if you get the drug or placebo.
Participation includes regular clinic visits, assessments, and follow-up.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be between 18 and 80 years old and have a confirmed diagnosis of Crohn's disease. You must have had an ileostomy (including a Kock pouch) for at least three months. Importantly, you would need to show signs of active Crohn's disease inflammation in the part of your small bowel just before your ileostomy, which will be checked through a special camera test (endoscopy).

There are also some reasons why you might not be able to join. For example, if you have other inflammatory bowel conditions, severe bowel blockages, or certain fistulas (abnormal connections between organs) that are not adequately treated. People who need full feeding support through a drip (total enteral or parenteral nutrition) throughout the study generally cannot participate.

We will also need to make sure that the special camera test can safely pass through your bowel. If you have had certain serious events like bowel perforation or peritonitis within the last three months, or if you have a high risk of bowel cancer in any remaining colon or rectum, you might not be eligible.

Quick self-check

Are you 18 to 80 years old?
Have you been diagnosed with Crohn's disease by a doctor?
Do you have an ileostomy (including a Kock pouch) that was placed at least 3 months ago?
Do you have active inflammation in the part of your small bowel near your ileostomy?
Are you willing and able to attend regular clinic visits and undergo study procedures?
Do you *not* currently have severe bowel blockages or other serious bowel problems that would prevent an endoscopy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will involve several stages. First, there's a screening period to check if you're suitable. Then, for 12 weeks, you'll enter the 'induction period' where you'll receive either the study drug (AZD7798) or the placebo. Neither you nor your study doctor will know which one you are getting during this time. Throughout the study, you'll have regular visits to the clinic for assessments, which will likely include physical examinations, blood tests, and occasionally repeat procedures like endoscopies to see how your gut is healing. After the first 12 weeks, if you meet certain criteria, you'll move into an 'open-label maintenance period' for 40 weeks, where all eligible participants will receive the active study drug. Finally, there will be follow-up visits 8 and 18 weeks after your last dose of the study medication, to keep an eye on your health. The total duration of participation will vary but can be up to about 18 months, including follow-up.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as receiving a new and experimental treatment that might help your condition, and contributing to medical knowledge that could help others in the future. However, there are also potential risks involved, which will be fully explained to you. These could include side effects from the study medication, the discomfort of procedures, or the possibility that the treatment may not benefit you. You might receive a placebo, which means you won't get the active drug at first. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

Research Site
Leuven, Belgium
Research Site
Padova, Italy
Research Site
Roma, Italy
Research Site
Rozzano, Italy
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Warsaw, Poland
Research Site
Linköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Kyiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Vinnytsia, Ukraine

+5 more sites — see the official record for the full list.

Common questions

What is an ileostomy?

An ileostomy is a surgical opening made in your tummy (abdomen) that brings the end of your small intestine (ileum) through to the outside. This allows waste to leave your body and collect in a pouch.

What does 'blinded study' mean?

In a 'blinded' study, neither you nor your study doctor will know whether you are receiving the active drug (AZD7798) or a placebo (a dummy drug) at the start. This helps ensure the study results are fair and accurate.

What is a placebo?

A placebo is a substance or treatment that looks exactly like the active study drug but doesn't contain any active medication. It's used to compare the effects of the new drug against no active treatment.

Will I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related medication and assessments will be provided at no cost to you.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.