Study on the Effectiveness and Safety of Vedolizumab, Budesonide, and Prednisone 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 Vedolizumab in children and teenagers with a condition known as Crohn’s disease. Crohn’s disease is a chronic inflammatory condition that affects the digestive tract, causing symptoms like abdominal pain, diarrhea, and weight loss. The purpose of the study is to evaluate how effective and safe Vedolizumab is when used as a maintenance therapy for those who have already shown improvement with initial treatment.

Participants in the study will receive Vedolizumab through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will compare two different dosing schedules of Vedolizumab to see which is more effective in maintaining the health of the participants over time. The study will last for a period of 54 weeks, during which the participants will be monitored for any changes in their condition and any side effects they might experience.

In addition to Vedolizumab, the study will also involve the use of other medications like Budesonide and Prednisone, which are types of corticosteroids used to reduce inflammation. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of Vedolizumab. The study aims to provide valuable information on the best ways to manage Crohn’s disease in young patients, helping to improve their quality of life.

1 initial treatment phase

The study begins with an open-label treatment phase where the medication vedolizumab is administered. This medication is given through an intravenous infusion, which means it is delivered directly into a vein.

During this phase, the goal is to achieve a clinical response, which means a noticeable improvement in symptoms of Crohn’s disease.

2 maintenance therapy

After achieving a clinical response, the patient enters the maintenance phase. This phase involves continued treatment with vedolizumab to maintain the improvement in symptoms.

The medication is administered at regular intervals, and the patient’s condition is monitored through clinical and endoscopic assessments.

3 medication details

The medication used in this trial is vedolizumab, which is given as a solution for infusion. The dosage and frequency are determined by the study protocol and are based on the patient’s response to the initial treatment phase.

4 assessment and monitoring

Throughout the trial, the patient’s health is closely monitored. This includes regular assessments of symptoms and endoscopic evaluations to check the condition of the intestines.

The primary goal is to achieve and maintain clinical remission, which means the symptoms are significantly reduced or absent.

5 end of trial

The trial is expected to conclude by November 2026. At the end of the study, the effectiveness and safety of vedolizumab as a maintenance therapy for pediatric patients with Crohn’s disease will be evaluated.

Who Can Join the Study?

Children and teenagers aged 2 to 17 years old, who weigh at least 10 kg (about 22 pounds) at the time of joining the study.
Participants must have been diagnosed with Crohn’s disease at least one month before joining the study. Crohn’s disease is a condition that causes inflammation in the digestive tract.
Participants should have moderately to severely active Crohn’s disease, which means their symptoms are more intense. This is determined by specific medical assessments.
Participants must have tried and not responded well to, or could not tolerate, at least one of the following treatments: corticosteroids (a type of medication that reduces inflammation), immunomodulators (medications like AZA, 6-mercaptopurine, methotrexate that help control the immune system), or TNF-α antagonist therapy (medications like infliximab, adalimumab that target specific proteins in the body to reduce inflammation).
Participants who have been using corticosteroids or special diets to manage symptoms but are experiencing worsening symptoms when trying to stop these treatments.
Participants with extensive colitis (inflammation of the colon) or pancolitis (inflammation of the entire colon) for more than 8 years, or left-sided colitis (inflammation on the left side of the colon) for more than 12 years, must have a recent colonoscopy showing no signs of cancer.
Participants must be up-to-date with their vaccinations according to the standard schedule for children in their country.

Who Cannot Join the Study?

Patients who do not have moderately to severely active Crohn’s disease cannot participate. Crohn’s disease is a condition that causes inflammation in the digestive tract.
Patients who are not within the specified age range for the study cannot participate. The study is for pediatric subjects, which means it is for children.
Patients who are not able to undergo clinical and endoscopic assessments cannot participate. An endoscopic assessment is a procedure where a doctor uses a special tool to look inside the digestive tract.
Patients who are not able to follow the study’s treatment plan or schedule cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have a history of certain infections or diseases that could affect the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Nosokomeio Paidon I Agia Sofia	Athens	Greece
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Uniwersytecki Szpital Dzieciecy W Krakowie	Cracow	Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Clinexpert Kft.	Budapest	Hungary
Klinika Za Djecje Bolesti Zagreb	Zagreb	Croatia
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Semmelweis University	Budapest	Hungary
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Vrije Universiteit Brussel	Jette	Belgium
Ujnrgsanzk On Aavdsmo	Edegem	Belgium
Utaxfxbuyc Deoed Smdxr Dn Rijf La Saisieua	Rome	Italy
Wqq Wbajdm Imf Pgwve Prmcptmd Kqsauct	Warsaw	Poland
Uqqkvekgbz Gzhyrrl Hnwuaabj Athlkpx	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	31.01.2022
Croatia	Recruiting	31.01.2022
Greece	Recruiting	31.01.2022
Hungary	Recruiting	31.01.2022
Italy	Recruiting	31.01.2022
Poland	Recruiting	31.01.2022

Trial locations

Investigated drugs:

Vedolizumab is a medication used in this clinical trial to help maintain the health of children with moderately to severely active Crohn’s Disease. It is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The trial aims to see how well this medication works in keeping the disease under control after the children have already shown improvement with initial treatment.

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 flares, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications like strictures or fistulas. The disease can vary in severity, with some people experiencing mild symptoms and others having more severe manifestations. The exact cause of Crohn’s disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.

Trial ID:

2023-509045-13-00

Protocol code:

MLN0002-3025

NCT ID:

NCT04779320

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Vedolizumab, Budesonide, and Prednisone for Children with Moderate to Severe Crohn’s Disease

What is this study about?

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