RecruitingPHASE2INTERVENTIONAL

A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

This study is testing a new medicine called Etrasimod for children aged 2 to 11 who have moderate to severe ulcerative colitis, a type of inflammatory bowel disease that affects the large intestine. The main goals are to find out if the medicine is safe to use, how well it helps control the condition, and how the child's body processes the medicine. Children who complete 52 weeks of treatment might have the opportunity to continue receiving Etrasimod for up to four more years. This research is important for finding better treatments for young people with ulcerative colitis. Ulcerative colitis can cause tummy pain, diarrhoea, and tiredness, so finding effective and safe treatments for children is a priority.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Pfizer

Enrolment target

Start

28 May 2026

Estimated completion

18 Aug 2034

Colitis, Ulcerative

What is this study about?

This clinical trial is looking into a medicine called Etrasimod for children who have a condition called ulcerative colitis. Ulcerative colitis is a long-term illness where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny open sores (ulcers). This can cause symptoms like tummy pain, bloody diarrhoea, and feeling very tired. It can be quite challenging for children and their families.

The study aims to see if Etrasimod is a safe and effective treatment for children aged 2 to 11 who have moderate to severe ulcerative colitis. This means their symptoms are noticeable and might be affecting their daily life. Researchers will also be checking how the children's bodies handle the medicine, including how much of it gets into their system and how quickly it's broken down. This helps doctors understand the right dose.

Finding new and better ways to treat ulcerative colitis in children is really important. Current treatments don't work for everyone, and having more options could significantly improve the quality of life for young patients. This study is an important step in potentially offering more help to children living with this condition.

Key takeaways

The study tests a new medicine, Etrasimod, for children with ulcerative colitis.
It's for children aged 2-11 with moderate to severe symptoms.
The main goals are to check safety, how well it works, and how the body handles it.
Participation involves regular clinic visits and taking the study medicine.
Children might continue treatment for up to 5 years if it's beneficial.
You can withdraw your child at any time without penalty.

Who may be eligible?

To be considered for this study, children need to have been diagnosed with ulcerative colitis that is currently moderate to severe. They might already be taking other medicines for their ulcerative colitis, and that's generally okay.

However, some children won't be able to join. This includes those with a very severe, widespread form of colitis. Also, children diagnosed with Crohn's disease, which is another type of inflammatory bowel disease, or a condition called indeterminate colitis, won't be eligible. If a child has very specific types of bowel inflammation like microscopic, ischemic, or infectious colitis, they also can't 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 aged between 2 and 11 years old?
Has your child been diagnosed with ulcerative colitis?
Are your child's ulcerative colitis symptoms currently moderate to severe?
Has your child NOT been diagnosed with Crohn's disease or other specific types of gut inflammation?
Does your child NOT have very severe widespread colitis?

Answer every question to see your result.

What does participation involve?

If a child joins the study, they will take the medicine Etrasimod as part of their treatment. The initial treatment period will last for 52 weeks, which is about one year. During this time, the study team will regularly check their health and how their ulcerative colitis is responding to the medicine. This will involve regular visits to the clinic, where doctors will carry out examinations, ask about symptoms, and take blood or other samples.

After completing the 52-week treatment, children who did well and who their doctor agrees, might have the chance to continue taking Etrasimod for a longer time, up to an additional four years. In total, if they participate in the extension, they could be in the study for up to five years from when they first started. Throughout this period, ongoing monitoring will ensure their safety and track the medicine's effects.

Potential risks and benefits

Like all medicines and studies, there are potential benefits and risks. A potential benefit of taking part is that your child might receive a new medicine that could improve their ulcerative colitis symptoms and overall health. The study team will closely monitor your child's health, which can be reassuring. Potential risks include side effects from the medicine, which will be carefully explained to you. There might also be some discomfort from clinic visits or tests. It's very important to remember that participating in this study is entirely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (25)

Health Sciences Centre Winnipeg
Verified postcode
Winnipeg, Canada· Not yet recruiting
Children's Hospital Research Institute of Manitoba
Verified postcode
Winnipeg, Canada· Not yet recruiting
CHU de Québec - Université Laval
Verified postcode
Québec, Canada· Recruiting
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Verified postcode
Bron, France· Recruiting
Hôpital Universitaire Necker Enfants Malades
Verified postcode
Paris, France· Not yet recruiting
Universitätsklinikum Münster - Albert Schweitzer Campus
Verified postcode
Münster, Germany· Not yet recruiting
Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany· Not yet recruiting
Universitaetsklinikum Tuebingen
Verified postcode
Tübingen, Germany· Recruiting
HELIOS Klinikum Wuppertal
Verified postcode
Wuppertal, Germany· Recruiting
Sheba Medical Center
Approximate
Ramat Gan, Israel· Not yet recruiting
Yitzhak Shamir Medical Center
Verified postcode
Ẕerifin, Israel· Not yet recruiting
Shaare Zedek Medical Center
Verified postcode
Jerusalem, Israel· Recruiting

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the large intestine (colon and rectum) becomes inflamed and can develop small sores, causing tummy pain and diarrhoea.

What is Etrasimod?

Etrasimod is the new medicine being tested in this study to see if it can help children with ulcerative colitis.

How long will my child be in the study?

Initially, your child will be in the study for about one year (52 weeks). There's a chance to continue for up to four more years if the medicine helps.

What age children can join?

The study is for children who are at least 2 years old but not yet 12 years old.

Can my child leave the study if we want to?

Yes, you can withdraw your child from the study at any time without giving a reason, and it won't affect their future medical care.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

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