RecruitingPHASE4INTERVENTIONAL

De-escalation of Ustekinumab Therapy in Patients With Crohn's Disease and Ulcerative Colitis

This study is for people in the UK with Crohn's disease or ulcerative colitis who are currently taking ustekinumab and whose condition is well-controlled. The main goal is to see if these patients can safely reduce how often they take their medication (e.g., from every 4 weeks to every 8 weeks, or every 8 weeks to every 12 weeks) while still keeping their symptoms at bay. Researchers will closely monitor blood test results, signs of inflammation, and the health of the bowel lining to make sure that reducing the dose doesn't cause their condition to worsen. The study aims to find out if a lower dose can be just as effective for maintaining good health.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

115

Start

08 Oct 2025

Estimated completion

15 Oct 2027

Crohn Disease (CD)Ulcerative Colitis (UC)

What is this study about?

If you have Crohn's disease or ulcerative colitis and are currently taking a medicine called ustekinumab (often known by its brand name, Stelara) and your condition is stable and well-controlled, this study might be of interest to you. Doctors sometimes use 'biologic' medicines like ustekinumab to calm the inflammation in your gut. Once your condition is much better and you're feeling well, doctors sometimes wonder if it's possible to reduce the amount of medicine you're taking without your symptoms coming back. This is often called 'de-escalation' or 'dose reduction'.

This study specifically wants to find out if people who are doing really well on ustekinumab can take their injections less often. For example, if you're currently having an injection every 4 weeks, could you safely move to every 8 weeks? Or if you're on injections every 8 weeks, could you move to every 12 weeks? The aim is to see if a slightly lower, less frequent dose can still keep your disease in remission – meaning your symptoms are gone or very mild.

Throughout the study, the research team will keep a close eye on your progress. They will check your blood levels of ustekinumab, look at markers in your blood that show inflammation, and even examine the lining of your gut to make sure everything stays healthy. By carefully monitoring these things, they hope to learn if reducing the dose of ustekinumab is a safe and effective option for patients like you.

Key takeaways

A study for people with Crohn's or ulcerative colitis whose symptoms are well controlled on ustekinumab.
It aims to see if you can take your ustekinumab injections less often.
Researchers will closely monitor your health to ensure your condition remains stable.
The study lasts for one year and involves 4-6 clinic visits.
May help reduce medication frequency if proven safe and effective.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to have Crohn's disease or ulcerative colitis and your condition must be very stable. This means your symptoms should be well under control, any inflammation in your body should have calmed down, and tests like endoscopies should show that your bowel is looking healthy. Importantly, you shouldn't be taking steroid medications (like prednisolone) for your condition when you join the study, as these can affect the results.

There are also some important points about other medications and health conditions. You cannot be on more than one type of biologic medicine at the same time. Also, if you've recently taken steroids (either by mouth or as an enema) within the last six months, you wouldn't be able to join. If you are pregnant or might become pregnant and are not using reliable contraception, you cannot take part. Similarly, if you have any issues that would make it hard for you to attend appointments or follow the study plan, you might not be eligible.

You need to be 18 years old or older to take part. Both men and women can join. If you are a woman who could become pregnant, you must be using an effective method of birth control throughout the study. Everyone joining must be willing and able to understand what the study involves and agree to take part.

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.

Do I have Crohn's disease or ulcerative colitis?
Are my symptoms currently well controlled with ustekinumab?
Am I NOT currently taking steroid medications (like prednisolone)?
Am I not pregnant or planning to become pregnant during the study?
Am I 18 years old or older?
Am I able to attend clinic visits every 12 weeks for a year?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement will last for 12 months (one year). During this time, you will have between 4 and 6 clinic visits. The main change for you will be to switch your ustekinumab injections to a less frequent schedule. This means you will either go from taking it every 4 weeks to every 8 weeks, or from every 8 weeks to every 12 weeks, depending on your current treatment plan.

At each of your clinic visits, which will happen roughly every 12 weeks, the study team will carry out check-ups and tests. These tests might include blood samples to measure the levels of ustekinumab in your body and to check for inflammation markers. They will also assess your general health and how you are feeling, to make sure your condition remains stable. The study team will explain all the procedures in detail and ensure you are comfortable.

Potential risks and benefits

A potential benefit of joining this study is finding out if you can maintain your good health with fewer injections, which could mean less frequent medication. There's also the chance that the study will help doctors learn more about the best way to manage Crohn's and ulcerative colitis, benefiting future patients. However, there's always a small risk that reducing your medication might cause your symptoms to return or worsen. If this happens, your doctor will discuss the best next steps for your ongoing care. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (1)

MUHC - Montreal General Hospital
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is ustekinumab?

Ustekinumab, also known by the brand name Stelara, is a medicine used to treat conditions like Crohn's disease and ulcerative colitis by helping to reduce inflammation in your gut.

What does 'de-escalation' mean in this study?

De-escalation means reducing the dose or frequency of a medication. In this study, it's seeing if you can take your ustekinumab injections less often, for example, every 8 or 12 weeks instead of every 4 weeks, while still keeping your disease under control.

Will I stop taking my medication completely?

No, this study is about taking your medication less frequently, not stopping it entirely. The goal is to see if a reduced dose can be just as effective.

How long will I be part of the study?

If you join, you will be part of the study for 12 months, which is one year.

What happens if my symptoms get worse during the study?

If your symptoms worsen, the study team and your usual doctor will discuss the best course of action and adjust your treatment to ensure you receive the care you need.

How to find out more

Waqqas Afif, MD

waqqas.afif@mcgill.ca 514-934-1943 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.