When your child has ulcerative colitis, family life can be difficult to manage. There may be times when your child is relatively symptom free. But as soon as his or her ulcerative colitis flares up, symptoms re-appear.

If ulcerative colitis is a challenging part of your family life, it may be worth exploring a clinical research study. The information on this website will help you understand more about the OVATION study. If you have any questions, please contact your doctor.

Who may participate

The OVATION clinical research study could be an option for your child if he or she:

  • Is between 2–17 years old and weighs at least 10 kg (approximately 22 pounds)
  • Has been diagnosed with ulcerative colitis for at least 12 weeks
  • Is experiencing ulcerative colitis symptoms (flare-up)
  • Has not experienced a blocked bowel and does not have an ostomy pouch

There are other requirements for taking part in this study. The study doctor will be able to explain these to you.

Condition

Ulcerative colitis

Age

2-17 years old

Sex

Male or Female

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

View more eligibility criteria

View more eligibility criteria

  • Aged between 2-17 years old
  • Weighs at least 10kg (approximately 22 pounds)
  • Has been diagnosed with ulcerative colitis for at least 12 weeks
  • Moderately to severely active UC based on Mayo score criteria
  • Pediatric Ulcerative Colitis Activity Index (PUCAI) score >35 at baseline
  • Has not experienced a blocked bowel and does not have an ostomy pouch
  • Diagnosis of indeterminate colitis, isolated proctitis, microscopic colitis, infectious colitis, clinical findings suggestive of Crohn’s disease
  • History of symptomatic obstructive bowel intestinal strictures or active ostomy
  • History of colectomy, extensive small bowel resection (>100 cm) or short bowel syndrome
  • Factors or clinical characteristics related to the risk of venous thromboembolism (VTE)
  • Previously received tofacitinib or another Janus kinase (JAK) inhibitor
  • Requires chronic and frequent use of antimotility agents for control of diarrhea

What to expect

Children who join the OVATION study will receive the study drug twice a day at home, either as tablets or a liquid.

They will take part for up to 43 months depending on how long they receive the study drug, and they would attend up to 23* clinic visits with one follow-up telephone call.

All study participants will be monitored frequently and supported by study site staff. Procedures to make sure patients are doing well will be required in this study; some of them are endoscopies, health questions, physical examinations, blood, urine and stool samples, and a daily bowel movement diary.

*Please note that if temporary local restrictions due to public emergencies, including COVID-19, mean study participants are unable to attend scheduled clinic visits, these may be carried out at their home, or via telephone call instead.

Length of study treatment

Up to 43 months

Number of study visits

Up to 23 visits

Long-term follow up

1 follow-up telephone call

About clinical research studies

Clinical research studies look for new ways to progress science and develop potential treatment options. They are designed to test the safety and effectiveness of investigational study drugs to understand if these potential treatments can be used in the future.

Even if participants don’t directly benefit from the results of the clinical study, the information collected can help others and add to scientific knowledge. People who take part in clinical studies are vital to the process of improving medical care.

Your child’s voluntary participation in this study may help to advance medical knowledge and improve quality of life for the millions of people, including children, living worldwide with ulcerative colitis.

About clinical research studies

Coloured silhouette of a child holding a balloon – Pfizer Clinical Trials – Pfizer Clinical Trials
Coloured silhouette of a child holding a balloon – Pfizer Clinical Trials – Pfizer Clinical Trials

About the OVATION study

Young child jumping and smiling at camera – Pfizer Clinical Trials
Young child jumping and smiling at camera – Pfizer Clinical Trials

About the OVATION study

The OVATION study is designed to assess the safety and effectiveness of an investigational study drug in children and adolescents with moderately to severely active ulcerative colitis. The study drug is an investigational drug because it is not yet approved for use in children or adolescents with ulcerative colitis.

Approximately 120 children and adolescents will join the OVATION study from countries all over the world.

The OVATION study brings together a team of doctors and staff who are dedicated to exploring medical knowledge about ulcerative colitis. Regular clinic visits will be scheduled, as they want to make sure participants are doing well throughout the study.

Frequently asked questions

What is ulcerative colitis?
Ulcerative colitis is a condition in which the digestive system becomes inflamed. Inflammation is the body’s response to injury or irritation and can cause redness, swelling and pain. In ulcerative colitis, the inner lining of the large bowel (colon and rectum) becomes inflamed and ulcers may develop on its surface lining.
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How can I tell if my child is having a flare-up?
The symptoms of a flare-up (relapse) may be slightly different from those your child had when they were first diagnosed with ulcerative colitis. If your child has a persistent tummy ache, fever, diarrhea, urgent bowel movement, blood in their stools, weight loss or general ill health, or if you are concerned in any way, you should consult your usual doctor or the study team.
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Can my child’s ulcerative colitis be cured?
Unfortunately, ulcerative colitis cannot currently be cured but a lot can be done to minimize its effects. Treatments are available that may help to control the inflammation and improve your child’s symptoms, and there may be times when he or she is relatively symptom-free.
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What is an investigational study drug?
An investigational study drug is a research study drug that has not been approved by the U.S. Food and Drug Administration (FDA), The European Medicines Agency (EMA), or similar agencies in other countries for prescription by doctors for a particular condition or is only approved for a particular condition in a restricted age group such as adults aged 18 years and older. In the OVATION study, the investigational study drug has not been approved for children or adolescents with ulcerative colitis.
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What is an endoscopy?

We will need to take a look at the lining of your child’s bowel so that the study doctor can check his or her ulcerative colitis. They will take a thin, flexible tube with a light and a tiny camera at the end (an endoscope), and will pass it through your child’s bottom into the bowel so that some pictures can be taken.

Before the procedure starts, the study doctor or nurse will give your child some medicine to make him or her feel relaxed or sleepy while he or she has the endoscopy.

Your child will be asked to take a laxative at home to clear his or her bowel before coming to the clinic for the endoscopy. It may be helpful to talk this through beforehand with the medical team, so you and your child know what to expect.

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What happens to my child’s personal information?
Information about your child’s personal health will be kept private and confidential. If you decide to contact us, your details will be transferred to the OVATION study team. A representative from the team will contact you to better understand if the study is right for your child. Your child’s personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the U.S. Food and Drug Administration (FDA) or other regulatory agencies
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