Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

This research study is investigating a medicine called ustekinumab, also known as Stelara, for children and teenagers who have moderately to severely active ulcerative colitis. This is a long-term condition that causes inflammation in the large intestine. The study aims to find out how well ustekinumab works to put the condition into remission (a period where symptoms reduce or disappear), how safe it is, and how the body handles the medicine. Participants will first receive the medicine through a drip, and then some will switch to injections under the skin, while others will receive a dummy medicine (placebo). The main goal is to see if participants feel much better after eight weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Janssen - Cilag International

Enrolment target

Start

03 Aug 2023

Moderately to Severely Active Ulcerative Colitis

What is this study about?

Ulcerative colitis is a long-term condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny sores. This can cause symptoms like tummy pain, frequent trips to the toilet, and sometimes blood in your poo. When the condition is 'moderately to severely active,' it means these symptoms are quite troublesome and regular.

This study is looking at a medicine called ustekinumab, also known by its brand name Stelara. This medicine works by targeting specific parts of the immune system that cause inflammation. It's already approved for adults with ulcerative colitis, and this study aims to see if it can be a safe and effective treatment option for younger people too. The researchers want to understand if it can help reduce inflammation and bring sustained periods of remission.

First, participants will receive ustekinumab as a drip (intravenous infusion) into a vein. After this initial treatment, some participants will continue with ustekinumab given as an injection under the skin, while others will receive a 'placebo' – which looks exactly like the real medicine but contains no active drug. This comparison helps researchers understand the true effects of the medicine. The study will carefully monitor how participants respond, looking especially at how many achieve 'clinical remission,' meaning their symptoms improve significantly or disappear.

Key takeaways

This study is testing a medicine (Stelara) for children and teens with ulcerative colitis.
It aims to see if the medicine is safe and helps symptoms improve.
Participants will get the first dose by drip, then some get injections of the medicine while others get a dummy injection.
Regular visits and tests will be needed to check your health.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is open to children and teenagers of all ages and genders who have been diagnosed with moderately to severely active ulcerative colitis. 'Moderately to severely active' means that your ulcerative colitis is causing significant symptoms and impact on your daily life, despite previous treatments or where current treatments aren't fully managing it.

There might be other specific health requirements or conditions that would mean you can't join the study, even if you have ulcerative colitis. These are in place to ensure the safety of everyone taking part and to make sure the study results are clear and accurate.

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 you have moderately to severely active ulcerative colitis?
Are you a child or teenager?
Are you able to attend regular clinic visits?
Do you understand that you might receive a placebo at some point?
Are you willing to have regular medical tests, including blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first receive the study medicine, ustekinumab, through a drip into your vein. This is called an 'induction' phase and usually happens in a clinic or hospital setting. After this, you'll be randomly assigned to either continue with ustekinumab injections under the skin or receive a 'placebo' injection (a dummy medicine) for the 'maintenance' phase. Neither you nor your study doctor will know which one you are receiving during this part.

You'll have regular visits to the clinic, which might involve physical examinations, blood tests, and sometimes stool samples or other assessments to check your health and how the medicine is affecting you. You'll also be asked to report any symptoms or side effects you experience. The total length of your participation in the study will vary, but studies like this often involve several months to over a year of regular monitoring and follow-up.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health by a specialist team. However, there are also potential risks; the medicine might have side effects, or it might not work for you. You could also receive a placebo instead of the active drug. Your study doctor will explain all known side effects and risks. Remember, 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 (4)

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

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Unverified
Germany
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Unverified
Hungary
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Unverified
Belgium
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Unverified
Poland

Common questions

What is ulcerative colitis?

It's a long-term condition that causes inflammation and sores in the lining of your large intestine (bowel), leading to symptoms like tummy pain and urgent toilet trips.

What is ustekinumab (Stelara)?

It's a medicine that works by calming down parts of the immune system that cause inflammation. It's already used for some inflammatory conditions in adults.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers understand if the real medicine is truly effective.

Will I definitely get the active medicine?

Initially, everyone gets ustekinumab by drip. After that, you'll be randomly assigned to either continue ustekinumab injections or receive a placebo. You won't know which one you're getting.

How long will the study last for me?

The study involves an initial treatment phase followed by a longer maintenance phase with regular check-ups. The total time can vary, but it often spans many months.