Study on Ustekinumab for Children with Moderate to Severe Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called ustekinumab in children with moderately to severely active Crohn’s disease. Crohn’s disease is a condition that causes inflammation in the digestive tract, leading to symptoms like stomach pain, diarrhea, and weight loss. The medication being tested, ustekinumab, is already used in adults and is being evaluated for its effectiveness and safety in children. It is administered in two forms: as an intravenous infusion, which means it is given directly into a vein, and as a subcutaneous injection, which is an injection under the skin.

The purpose of the study is to see if ustekinumab can help bring about clinical remission, which means reducing the symptoms of Crohn’s disease to a minimal or non-existent level. The study begins with an open-label phase, where all participants receive ustekinumab through an intravenous infusion. After this initial phase, participants are randomly assigned to receive either ustekinumab or a placebo as a subcutaneous injection. This part of the study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo.

The study will monitor the participants over a period of time to assess the medication’s safety and how well it works in reducing the symptoms of Crohn’s disease. The trial aims to gather information on how the body processes ustekinumab, which is referred to as pharmacokinetics. The ultimate goal is to determine if ustekinumab is a safe and effective treatment option for children with this condition.

1 induction period

Upon joining the study, you will begin the induction period. During this time, you will receive an intravenous infusion of ustekinumab. This medication is provided as STELARA 130 mg concentrate for solution for infusion. The infusion is administered directly into your vein.

The purpose of this phase is to help induce remission of your Crohn’s disease symptoms. This period lasts for approximately 8 weeks, and the goal is to assess the initial response to the treatment.

2 maintenance period

Following the induction period, you will enter the maintenance period. During this phase, you will receive ustekinumab through subcutaneous injections. This means the medication is injected under your skin.

The medication is provided as STELARA 90 mg solution for injection in pre-filled syringe or STELARA 45 mg solution for injection, depending on your specific needs. The injections are administered at regular intervals to maintain the effects of the treatment.

This phase is designed to help sustain the remission of your symptoms and will continue for the duration of the study.

3 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate your response to the treatment. This includes physical examinations, laboratory tests, and questionnaires about your symptoms and overall health.

These assessments are crucial to ensure your safety and to gather data on the effectiveness of the treatment. Your participation in these assessments is essential for the success of the study.

4 end of study

At the end of the study, a final evaluation will be conducted to assess the overall impact of the treatment on your Crohn’s disease. This will include a comprehensive review of your health status and any changes in your symptoms.

The information gathered during this final assessment will contribute to the understanding of the treatment’s long-term effects and its potential benefits for other patients with similar conditions.

Who Can Join the Study?

Must have been diagnosed with Crohn’s disease or fistulizing Crohn’s disease with active inflammation in the intestines, confirmed by a doctor using a camera test (endoscopy) and tissue sample analysis (histology).
Must have moderately to severely active Crohn’s disease, which means having a specific score on a health assessment (Pediatric Crohn’s Disease Activity Index) greater than 30. This includes having a camera test (ileocolonoscopy) showing active disease with ulcers, or meeting other specific health markers if the camera test cannot be completed.
If receiving enteral nutrition (a special liquid diet), must have been on a stable diet plan for at least 2 weeks before starting the study.
Females who can have children must have a negative pregnancy test before starting the study and at the beginning of the study period.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medication or its ingredients cannot participate.
Patients with active infections, such as tuberculosis, cannot participate.
Patients who have received certain vaccines within a specific time frame before the study starts cannot participate.
Patients with a history of cancer, except for certain types of skin cancer, cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain blood disorders cannot participate.
Patients who have used other investigational drugs within a certain period before the study cannot participate.
Patients with a history of drug or alcohol abuse cannot participate.
Patients with certain heart conditions cannot participate.
Patients who have had a recent surgery or are planning to have surgery during the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Semmelweis University	Budapest	Hungary
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
University Of Debrecen	Debrecen	Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Universitaetsklinikum Aachen AöR	Aachen	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Vrije Universiteit Brussel	Jette	Belgium
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Uniwersytecki Szpital Dzieciecy W Krakowie	Cracow	Poland
University Of Szeged	Szeged	Hungary
MD Korczowski Bartosz Gabinet Lekarski	Rzeszow	Poland
Lpmmxh Masrxrykys Ukyjcrxufm Oo Mgstra	Munich	Germany
Cbmlbmsmc Upowyptfluuvrc Sftzxvwxy	Woluwe-Saint-Lambert	Belgium
Uemjrnepzgwqqanpfvlch Ejuzd Agf	Essen	Germany
Wzu Wbpsog Ieb Plqbi Paymrswq Koevtgr	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.01.2021
Germany	Not recruiting	15.01.2021
Hungary	Not recruiting	15.01.2021
Poland	Not recruiting	15.01.2021

Trial locations

Investigated drugs:

Ustekinumab

Ustekinumab is a medication used in this clinical trial to help treat children with Crohn’s disease, which is a condition that causes inflammation in the digestive tract. This medication works by targeting specific proteins in the body that are involved in the inflammatory process. By doing so, it helps to reduce the inflammation and symptoms associated with Crohn’s disease. In this study, the medication is first given through an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein. After the initial treatment, it is then given as an injection under the skin to maintain its effects. The goal of using ustekinumab in this trial is to see if it can help children achieve remission, meaning their symptoms are reduced or disappear, and to ensure it is safe for them to use.

Investigated diseases:

Crohn's disease

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 active disease, known as flares, and periods of remission. During active phases, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can affect different layers of the bowel wall and may lead to complications like strictures or fistulas. The exact cause of Crohn’s Disease is unknown, but it involves an abnormal immune response to intestinal bacteria. The disease can vary in severity and may progress over time, affecting different areas of the digestive tract.

Trial ID:

2023-504978-38-00

Protocol code:

CNTO1275CRD3004

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ustekinumab for Children with Moderate to Severe Crohn’s Disease

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