Not recruiting

Study on Upadacitinib for Children with Moderate to Severe Crohn's Disease

Verified siteRegistered drugNo 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 with Crohn's Disease, which is a condition that causes inflammation in the digestive tract. The study aims to evaluate how well this medication works, its safety, and how it behaves in the body. Participants in the study will receive Upadacitinib in different forms, such as oral solutions and tablets, over a period of time. The study will also involve a comparison with a placebo to understand the medication's effectiveness better.

The trial is designed to help children who have not responded well to other treatments like corticosteroids, immunosuppressants, or biologic therapies. The study will begin with an open-label phase, where all participants receive Upadacitinib. This will be followed by a randomized, double-blind phase, where participants will either continue with the medication or receive a placebo without knowing which one they are taking. The study will also include a long-term extension phase where participants can continue to receive Upadacitinib.

The main goal of the study is to see if Upadacitinib can help achieve clinical remission, which means reducing the symptoms of Crohn's Disease to a minimal level, and an endoscopic response, which involves healing of the digestive tract as seen through a special camera. The study will monitor participants for any side effects and measure their response to the treatment over time. This research is important for finding new ways to help children with Crohn's Disease who have limited treatment options.

The research process

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

Step 1
Induction phase
The trial begins with an open-label induction phase. During this phase, the medication upadacitinib is administered. The form of administration is an oral solution.
The purpose of this phase is to evaluate the initial response to the medication. The duration of this phase is not specified, but it is designed to assess the effectiveness of the treatment in achieving a clinical response.
Step 2
Maintenance phase
Participants who achieve a clinical response during the induction phase enter the randomized, double-blind maintenance phase. This phase involves continued administration of upadacitinib.
The medication is provided in a prolonged-release tablet form. The goal is to maintain the clinical response and assess the long-term effectiveness and safety of the treatment.
Step 3
Long-term extension phase
Following the maintenance phase, participants may enter an open-label long-term extension phase. This phase allows for continued access to upadacitinib for those who benefit from the treatment.
The form of administration remains as an oral solution or prolonged-release tablet, depending on the participant's needs and the study protocol.

Who can join the trial?

6 criteria

The patient must have a weight of at least 10 kg (about 22 pounds) at the start of the study.
The patient must have **moderate to severe Crohn's Disease**. This means a score higher than 30 on a special scale called the **Pediatric Crohn's Disease Activity Index (PCDAI)**, and signs of inflammation in the intestines seen through a test called an **endoscopy**.
The patient must have a confirmed diagnosis of **Crohn's Disease** before starting the study. This diagnosis should be confirmed by a procedure called a **colonoscopy**, which involves looking inside the colon with a camera, and by examining tissue samples.
The patient must have tried certain treatments like **corticosteroids**, **IMMs** (immune-modulating medications), or **biologic therapy** and found them not effective, or they must be unable to use these treatments for medical reasons. In the US, the patient must have tried and not responded well to at least one **anti-TNF** medication, which is a type of treatment that targets a specific protein involved in inflammation.
The patient must be between the ages of 2 and 17 years old.
Both male and female patients can participate in the study.

Who cannot join the trial?

4 criteria

Patients who have not achieved a clinical response by Week 12 cannot participate.
Patients who have not been randomized into the maintenance phase cannot participate.
Patients who are not within the age range specified for the trial cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Nosokomeio Paidon I Agia Sofia
Athens, Greece

Trial locations

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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 Crohn's Disease. This trial aims to see if it can help achieve clinical remission and improve endoscopic response in patients who have not responded well to other treatments like corticosteroids, immunosuppressants, or biologic therapies. The study involves 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 a Phase 3 clinical trial for its effectiveness in treating Crohn's Disease, particularly in pediatric patients with moderate to severe symptoms who have not responded well to other treatments. Upadacitinib is a Janus kinase (JAK) inhibitor, which works by blocking specific enzymes involved in the inflammatory process, thereby reducing inflammation in the body. It is classified as an immunosuppressant and is being evaluated for its ability to induce and maintain clinical remission and endoscopic response in patients.

Investigated diseases

Crohn's Disease – Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. Common symptoms include abdominal pain, diarrhea, weight loss, and fatigue. The inflammation can lead to complications such as strictures, fistulas, and malnutrition. The exact cause of Crohn's Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The disease can affect individuals of any age, but it often begins in adolescence or early adulthood.