RecruitingPHASE2, PHASE3INTERVENTIONAL

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

This research study is looking at a new oral medicine called ozanimod for children and teenagers (aged 2 to 17 years old) who have moderate or severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation in the large bowel. We are particularly interested in children whose condition hasn't improved much with standard treatments like oral aminosalicylates, steroids, or other stronger medicines. The main aim of this study is to find out how well ozanimod works in helping children achieve and maintain 'remission' – which means their symptoms are much better or have gone away. We also want to understand if the medicine is safe for them to take. Participants will take ozanimod by mouth.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

120

Start

30 May 2022

Estimated completion

14 Aug 2031

Colitis, Ulcerative

What is this study about?

Ulcerative colitis is a condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops tiny open sores, called ulcers. This can cause symptoms like tummy pain, urgent and frequent trips to the toilet, and sometimes blood in your poo. For children living with this condition, it can be particularly hard, affecting their schooling, social life, and overall well-being.

Often, doctors start with standard treatments, but sometimes these don't work well enough, or their effects wear off. When this happens, doctors need other options to help manage the condition and improve the child's quality of life. This study is exploring a new oral medicine called ozanimod (also known as RPC1063) as a potential new treatment.

The main goal of this study is to see if ozanimod can help children and teenagers (aged 2 to 17) whose moderate to severe ulcerative colitis hasn't responded to other treatments. We want to find out if it can help them achieve and stay in 'remission', meaning their symptoms are under control. We also carefully monitor for any side effects to ensure the medicine is safe.

Key takeaways

Tests new oral medicine ozanimod for ulcerative colitis.
Aimed at children aged 2-17 with moderate to severe disease.
For those who haven't responded to other treatments.
Checks both how well the medicine works and if it's safe.
Involves regular clinic visits and health checks.

Who may be eligible?

To be considered for this study, children and teenagers generally need to be between 2 and 17 years old and have been diagnosed with moderate to severe ulcerative colitis that affects their bowel beyond the very end part. They would also need to have tried and not responded well to, or had problems with, at least one common type of ulcerative colitis treatment, such as certain tablets (aminosalicylates), steroids, or other stronger medications.

There are some reasons why a child might not be able to join the study. For example, if they have a different bowel condition like Crohn's disease, or if they have a current infection called Clostridium difficile (C. diff) which can cause similar gut symptoms. Also, if they have certain conditions affecting their immune system, they might not be suitable.

The study team will review each child's medical history carefully to make sure they meet all the necessary requirements for joining, and that it's safe for them to participate.

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 17 years old?
Does your child have moderate to severe ulcerative colitis?
Has their ulcerative colitis not improved with other standard treatments?
Does your child NOT have Crohn's disease or a C. diff infection?
Does your child NOT have a known immune system problem or genetic condition causing colitis?

Answer every question to see your result.

What does participation involve?

The study involves several visits to the clinic for assessments. During these visits, doctors will check your child's health, discuss their symptoms, and likely collect blood and stool samples. They may also perform endoscopies (a procedure to look inside the bowel with a small camera) to check the inflammation. Your child will be given the study medicine, ozanimod, to take by mouth. The total duration of participation, including regular check-ups and follow-up after treatment, will be explained in detail by the study team. They will also provide specific instructions on how and when to take the medication and what to watch out for.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new medication that might help your child's ulcerative colitis when other treatments haven't worked. However, like all medicines, ozanimod may have side effects, and it's possible it may not benefit your child. The research team will explain all known potential risks and benefits thoroughly before you decide whether to participate. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting their future medical care.

Locations (90)

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

Local Institution - 0041
Verified postcode
Phoenix, United States· Withdrawn
University of Arizona
Verified postcode
Tucson, United States· Withdrawn
Local Institution - 0052
Verified postcode
Garden Grove, United States· Completed
Loma Linda University Health System
Verified postcode
Loma Linda, United States· Recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Lucile Packard Children's Hospital
Verified postcode
Palo Alto, United States· Not yet recruiting
University of California Davis Health
Verified postcode
Sacramento, United States· Recruiting
Local Institution - 0007
Verified postcode
Hartford, United States· Completed
Local Institution - 0064
Verified postcode
Washington D.C., United States· Completed
Local Institution - 0075
Verified postcode
Orlando, United States· Completed
Local Institution - 0016
Verified postcode
Atlanta, United States· Completed
Local Institution - 0101
Verified postcode
Park Ridge, United States· Not yet recruiting

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of the large bowel (colon and rectum) becomes inflamed and develops small sores, causing symptoms like tummy pain and urgent bowel movements.

What is ozanimod?

Ozanimod is a new oral medicine being tested to see if it can help reduce inflammation and improve symptoms in children and teenagers with ulcerative colitis.

Who is this study for?

This study is for children and teenagers aged 2 to 17 years old who have moderate to severe ulcerative colitis that hasn't responded well to standard treatments.

Will my child have to stay in hospital?

No, this study does not typically require your child to stay in the hospital. They will attend regular clinic visits and take medication at home.

What if we change our minds about participating?

Participation is completely voluntary. You and your child can decide to leave the study at any time, for any reason, and this will not affect your child's usual medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

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