By participating in the ELEVATE KIDS Study, you can help us learn if a study medicine can improve symptoms in children with ulcerative colitis.

In this global, multicenter study, a once-daily oral medicine approved for use in adults with ulcerative colitis will be given to children with this condition. Our goal is to understand the efficacy and safety of the study medicine using doses adjusted for children’s growing bodies.

Who may participate

 

The study is enrolling children who: 

  • Are 2 to 11 years of age (before their 12th birthday when they take their first dose of study medicine).
  • Have moderately to severely active ulcerative colitis.
  • Have been treated previously with at least one medicine for ulcerative colitis, such as 5-ASA, a corticosteroid, or a biologic therapy. 

There will be other study requirements that the study team will discuss with you. 

Participating in a study is your choice. You can choose to leave at any time for any reason without penalty.

Condition

Moderate to Severe Ulcerative Colitis

Age

2-11 years

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.

What to expect

If this study is a good fit for your child and you decide to take part, your child will take a once-daily study medication by mouth that can be swallowed whole or mixed with soft food, for a period of one year. If the study medication has helped your child’s symptoms, they may continue taking it for an additional 4 years. 

The study doctor will determine if your child may continue taking medication for ulcerative colitis that they are currently taking. 

During the first year, you will visit the study clinic once a month. After the first year, visits will be less frequent. 

Your child will be asked to complete an electronic diary (eDiary) to keep track of their number of stools and rectal bleeding. We will provide guidance on how to do this.

Length of study treatment

Up to 5 years

Number of study visits

Up to 30 visits

Long-term follow up

After year 1, option to continue for 4 years

Your Journey and Your Choice

Child drawing while mom looks – Pfizer Clinical Trials
Child drawing while mom looks – Pfizer Clinical Trials

Your Journey and Your Choice

Participant safety is the top priority of this clinical study. Before your child participates, you will be given all the details about the study, including potential benefits and risks of taking part. Your child’s health will also be monitored by the study team while in the study. 

If this study is a good fit for your child and you decide to take part, it’s important to remember that this is your family’s journey and choice. Your child is free to stop being in this study at any time and for any reason. 

Your family’s participation in this research can make a difference for children with ulcerative colitis.

Health Checks and Tests

Your child’s safety and well-being are always the top priority and we will monitor this throughout the study. At the 3-month visit and the 1-year visit, we will do comprehensive tests to see if the study medicine is helping your child’s ulcerative colitis. 

Tests include but are not limited to: 

  • Physical exam
  • Blood tests
  • Urine test
  • Stool test
  • Questionnaires
  • Heart test
  • Eye scan
  • Breathing test
  • Colonscopy/proctosigmoidoscopy with biopsy 

Your child will receive the study medicine, tests, and doctor visits at no cost.

Health Checks and Tests

Children Laughing – Pfizer Clinical Trials
Children Laughing – Pfizer Clinical Trials

Frequently asked questions

What are the possible benefits of participating in this clinical trial?

Your child will be given an ulcerative colitis medication that is already being used by adults. How the study medicine works in children is unclear, but it may involve a decrease in some types of immune cells reaching the colon. This may help lower inflammation and improve symptoms of ulcerative colitis such as frequent visits to the bathroom and bleeding. Additionally, your child’s health will be closely monitored by the study team, and you will be helping to advance a potential medicine for children with ulcerative colitis.

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What are the potential risks of participating in this clinical trial?

The study medicine may cause serious symptoms or side effects, including: very common - decrease in the count of a type of white blood cell called lymphocytes, which typically fight off infection. Common side effects are headache, increase in liver enzymes, dizziness, urinary infection, increased cholesterol and increased blood pressure, slowed heart rate and visual impairment. Uncommon side effects are decrease or delay of electrical activity through the heart, and eye problem called macular edema.. There may be other risks that are unknown at this time. The study team will provide more information about the potential benefits and risks of taking part.

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What will happen at the study visits? 

What happens at each study visit will vary and some visits may take longer than others. Your child may have blood tests, ECG, eye exam, chest x-rays, colonoscopy/proctosigmoidoscopy with biopsy, physical exams, and lung function tests done during visits. The study team will give you more information about the tests and procedures required at each visit during the review of the Informed Consent Document (ICD).

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Is there anything I am required to do outside of going to study visits?

Your child will be asked to use an electronic diary (eDiary) to answer questions about 1) stool frequency – how often your child uses the toilet to pass stools and 2) rectal bleeding presence and amount of blood in the stool. The study team will show you how to use the eDiary and review the answers. The eDiary must be completed daily throughout the study for the first year and 2 weeks before visit on other years of the study.

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What if I change my mind?

Your child is free to stop being in this study at any time for any reason. Your decision to stop being in the study will not affect your child’s regular medical care or any benefits to which your child is entitled.

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