Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis

This research is a 'Phase 3' study, which means it's one of the last steps before a medicine might become widely available. Doctors are testing a medication called Simponi in children and young people who have a condition called ulcerative colitis. This condition causes inflammation in the large bowel, leading to symptoms like tummy pain and diarrhoea. The study aims to find out if Simponi is effective at making people's symptoms go away (this is called 'clinical remission') and helping their gut heal. It also checks if the medicine is safe to use and how it works in the body when given as an injection under the skin.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Janssen - Cilag International, Janssen Biologics B.V.

Enrolment target

Start

31 Jul 2024

Ulcerative Colitis

What is this study about?

This study is about an important medicine called Simponi (which is also known by its medical name, golimumab). It's for children and teenagers who have moderately to severely active ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of the large bowel (colon and rectum) becomes inflamed and develops tiny sores, called ulcers. This can cause symptoms like tummy pain, diarrhoea that might contain blood, and needing to go to the toilet urgently.

The main goal of this study is to see if Simponi can help young people with ulcerative colitis go into 'remission.' This means their symptoms would get much better or even disappear, almost like the condition is sleeping. The study will also look at whether Simponi helps the gut to heal on the inside. They will use different ways to measure this, including special scores that doctors use to check how active the disease is and by looking inside the bowel with a camera.

Simponi works by blocking a protein in the body called TNF-alpha, which plays a big part in inflammation. By blocking it, Simponi helps to calm down the inflammation in the gut. This study is crucial because it helps doctors understand if this treatment is a good option for managing ulcerative colitis in younger patients, helping them to live more comfortably and with fewer symptoms.

Key takeaways

This study is for children and teenagers with moderate to severe ulcerative colitis.
It's testing a medicine called Simponi, given as an injection, to see if it helps reduce symptoms and heal the gut.
The study will closely monitor safety and how well the treatment works.
Participation involves regular clinic visits for assessments and medication.
This is a 'Phase 3' study, meaning it's one of the final stages of testing a new medicine.

Who may be eligible?

This study is open to both boys and girls of any age who have been diagnosed with ulcerative colitis. The important thing is that their ulcerative colitis needs to be active, meaning they are currently experiencing symptoms that are moderate to severe.

While the exact details of who can join are not fully listed here, generally, studies like this look for people who haven't responded well enough to other treatments, or perhaps they can't take other treatments. There might also be other health conditions that would prevent someone from joining, to ensure their safety.

If you or your child has ulcerative colitis and you're interested in this study, it's really important to talk to your doctor. They will have all the detailed information about who is suitable 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/does my child have ulcerative colitis?
Is my/my child's ulcerative colitis currently active and causing moderate to severe symptoms?
Am I/is my child comfortable with injections under the skin?
Am I/is my child able to attend regular clinic visits for assessments?
Have I discussed my interest with my current doctor?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve getting doses of the study medicine, Simponi, through an injection under the skin. Depending on the type of injection, it could be given with a pre-filled syringe or a pre-filled pen. You would have regular visits to the clinic so the medical team can check how you are doing, monitor your symptoms, and carry out assessments like blood tests or stool samples. They will use special scores, like the Mayo score and PUCAI score, to track your progress and see if your symptoms are improving. There might also be times when doctors need to look inside your bowel with a camera (endoscopy) to check for healing. The total duration of participation and how often these visits occur would be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this could bring potential benefits, such as receiving a new treatment that might help improve your ulcerative colitis symptoms and gut healing. However, like all medicines, Simponi can have side effects, and some risks are involved. These will be thoroughly explained by the study team, and your health will be closely monitored throughout. You would always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Poland
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Unverified
France
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Unverified
Italy

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large bowel, leading to symptoms like tummy pain and diarrhoea.

What is Simponi?

Simponi is a medicine being tested in this study that works by calming down inflammation in the body, which can help with conditions like ulcerative colitis.

How is Simponi given?

Simponi is given as an injection under the skin, using either a pre-filled syringe or a pre-filled pen.

What does 'clinical remission' mean?

Clinical remission means that your symptoms have significantly improved or have disappeared, making you feel much better.

Can I stop being in the study if I change my mind?

Yes, you are always free to leave the study at any time, and this will not affect your usual medical care.