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Study on Upadacitinib for Children with Moderate to Severe Ulcerative Colitis

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Upadacitinib in children and teenagers with Ulcerative Colitis. Ulcerative Colitis is a condition that causes inflammation and sores in the lining of the large intestine. The study aims to evaluate how well the medication works, its safety, and how it behaves in the body. Upadacitinib is a type of medication known as a Janus kinase (Jak) inhibitor, which helps to reduce inflammation by blocking certain signals in the body.

The trial involves several stages. Initially, all participants will receive Upadacitinib in an open-label phase, meaning everyone knows they are receiving the medication. After this, participants will be randomly assigned to either continue with Upadacitinib or receive a placebo in a double-blind phase, where neither the participants nor the researchers know who is receiving which treatment. This helps to ensure the results are unbiased. The study will also include a long-term extension phase where participants may continue to receive Upadacitinib openly.

The goal is to see if Upadacitinib can help achieve remission, which means the symptoms of Ulcerative Colitis are reduced or disappear. The study will look at how many participants achieve remission after 8 weeks and again after 52 weeks. Participants will be monitored throughout the study to assess the medication's effectiveness and any side effects. This trial is important for understanding how Upadacitinib can be used to treat Ulcerative Colitis in young patients who have not responded well to other treatments like corticosteroids, immunosuppressants, or biologic therapies.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction phase

    The induction phase begins with the administration of upadacitinib, a medication taken orally. The form of the medication is a modified-release tablet or oral solution.

    The goal during this phase is to achieve clinical remission by Week 8, as measured by the Adapted Mayo Score (AMS).

  2. Step 2

    Maintenance phase

    Participants who respond to the treatment in the induction phase enter the maintenance phase. This phase involves continued administration of upadacitinib.

    The objective is to maintain clinical remission at Week 52 for those who responded by Week 8.

  3. Step 3

    Long-term extension phase

    Participants may continue to receive upadacitinib in an open-label format for long-term observation.

    This phase aims to monitor the long-term safety and effectiveness of the treatment.

Who can join the trial?

6 criteria

  • Children, both boys and girls, aged 2 to 17 years can participate.
  • Participants must have **moderately to severely active Ulcerative Colitis (UC)**. This means they have a specific score between 5 to 9 points and a certain result from a test called an endoscopy, which looks inside the colon.
  • Participants should have tried treatments like **corticosteroids**, **immunosuppressants**, or **biologic therapy** and either didn't respond well, stopped responding, couldn't tolerate them, or have medical reasons not to use them.
  • Participants must weigh at least 10 kilograms at the time of screening and the start of the study.
  • Participants need to have a confirmed diagnosis of UC before starting the study, verified by a colonoscopy, which is a procedure to look inside the colon. They should not have any current infections, abnormal cell growth in the colon, or cancer.
  • Participants must have stopped using certain **biologic agents** like infliximab and adalimumab, or similar drugs, at least two times the duration it takes for half of the drug to leave the body before starting the study. For other biologic agents or procedures, they should have stopped 30 days or five times the duration it takes for half of the drug to leave the body, whichever is longer. They should not be part of another clinical study at the same time.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have used certain medications that might affect the study results.
  • Patients who have had a recent surgery or are planning to have surgery during the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a known allergy to any of the study medications.
  • Patients who have a condition that affects their immune system, making them more prone to infections.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Upadacitinib is a medication being studied for its effectiveness and safety in treating children with moderately to severely active ulcerative colitis. This condition is a type of inflammatory bowel disease that causes inflammation and ulcers in the digestive tract. The trial aims to see if this medication can help achieve remission in patients who have not responded well to other treatments like corticosteroids, immunosuppressants, or biologic therapies. The study includes an open-label induction phase, a randomized double-blind maintenance phase, and an open-label long-term extension phase to thoroughly evaluate the medication's impact over time.

What is already known about the treatment

Upadacitinib – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating ulcerative colitis, particularly in pediatric patients who have not responded well to other treatments like corticosteroids or biologics. Upadacitinib is a Janus kinase (JAK) inhibitor, which works by blocking specific enzymes involved in the inflammatory process, thereby reducing inflammation in the colon. It is classified as an immunomodulator and is being evaluated for its safety and efficacy in achieving clinical remission in patients with moderate to severe ulcerative colitis.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remission. Over time, the inflammation can lead to complications such as colon damage. The exact cause is unknown, but it is believed to involve an abnormal immune response.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501788-41-00Protocol codeM14-658Estimated enrolment126 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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