Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

This study is for children and teenagers who have moderate to severe ulcerative colitis, a condition that causes inflammation in the large bowel. Participants will have already responded to an initial course of Entyvio, a medicine. The main goal is to find out if continuing to take Entyvio helps them stay healthy and free from symptoms for longer (this is called 'clinical remission'). Researchers will also check how safe Entyvio is and look at other ways it might help, such as reducing inflammation seen during a colonoscopy. Some participants will receive the active medicine, while others will receive a placebo (a dummy medicine) to fairly test Entyvio's effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

Start

18 Jun 2024

Moderately to severely active Ulcerative Colitis (UC)

What is this study about?

This study is all about helping children and teenagers who have ulcerative colitis, a type of inflammatory bowel disease where the lining of the large bowel becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, urgent trips to the toilet, and blood in their poo. The children taking part in this study will have what doctors call 'moderate to severe' ulcerative colitis, meaning their symptoms are quite bothersome.

The main aim of the study is to see if a medicine called Entyvio (which is given through a drip, or intravenously) can help these young people stay well and keep their symptoms under control over a longer period. Before joining this part of the study, all participants would have already received Entyvio as part of an earlier phase and responded well, meaning their symptoms improved. Now, the study wants to see if continuing this treatment is effective in maintaining that improvement.

To do this, some children will keep receiving Entyvio, while others will be given a placebo (a treatment that looks exactly like Entyvio but contains no active medicine). This is a common way to test new medicines fairly. The researchers will be looking closely to see if Entyvio helps keep their symptoms in remission (meaning they have very few or no symptoms, like less frequent and more normal poos, and no blood), and if it helps reduce inflammation in their bowel. They'll also be tracking any side effects to make sure the treatment is safe.

Key takeaways

The study investigates Entyvio for children and teenagers with moderate to severe ulcerative colitis.
It checks if Entyvio helps maintain symptom relief (remission) after initial successful treatment.
Participants will receive either Entyvio or a placebo (dummy medicine) through a drip.
The study will last for about one year, with regular medical check-ups.
Safety and effectiveness of Entyvio will be carefully monitored.

Who may be eligible?

This study is designed for children and teenagers who have been diagnosed with moderate to severe ulcerative colitis. There are no specific age limits mentioned, so participants could be of any age, as long as they fit other study criteria for children and teenagers.

Crucially, all participants must have already received a course of Entyvio treatment and shown a good response to it. This means their ulcerative colitis symptoms must have improved after their initial treatment with Entyvio. The study is open to both boys and girls.

There will be other medical checks and criteria that the study doctors will need to review to make sure it's safe and appropriate for a child 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.

Is your child a diagnosed with moderate to severe ulcerative colitis?
Has your child previously received Entyvio treatment?
Did your child's symptoms improve after their initial Entyvio treatment?
Are you comfortable with your child receiving either the study medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you join this study, your child will first receive Entyvio through a drip. After this initial treatment, if their symptoms improve, they might be offered a chance to continue in this specific phase of the study. Here, they will either keep receiving Entyvio or an inactive placebo, given through a drip, for about 54 weeks (just over a year).

Throughout the study, there will be regular visits to the clinic where doctors and nurses will monitor your child's health closely. This will include physical exams, asking questions about symptoms, and possibly blood tests and stool samples. They will also have endoscopy procedures (where a small camera is used to look inside the bowel) at certain times to check for inflammation. The doctors will be looking for specific signs of improvement, like changes in stool frequency, any rectal bleeding, and what they see during an endoscopy. The total duration of this part of the study is just over one year, with careful follow-up during and after treatment.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as continued symptom control for ulcerative colitis, possibly helping your child stay well for longer. However, there are also potential risks, including side effects from the medication (Entyvio or prednisone if used), discomfort from procedures like blood tests or endoscopies, and the possibility that the treatment might not work or they might receive the placebo. Your child's well-being is paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your child's future medical care.

Locations (6)

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

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Unverified
Greece
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Unverified
Croatia
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Unverified
Italy
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Unverified
Poland
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Unverified
Belgium
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Unverified
Hungary

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of the large bowel and rectum becomes inflamed, causing symptoms like tummy pain, diarrhoea, and blood in poo.

What is Entyvio?

Entyvio is a medicine given through a drip that helps reduce inflammation in the bowel for people with conditions like ulcerative colitis.

What does 'remission' mean?

'Remission' means that your child's symptoms have significantly improved or disappeared, and they are feeling much better.

Why might some children receive a 'placebo'?

A placebo is a dummy treatment. It's used to fairly compare the real medicine against something with no active ingredients, helping researchers truly understand if the medicine works better than nothing at all.

How long will the study last?

The main part of this study will last for about 54 weeks, which is just over one year, with regular check-ups during that time.