Study on Vedolizumab for Children with Moderate to Severe Ulcerative Colitis

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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 Ulcerative Colitis. Ulcerative Colitis is a disease that causes inflammation and sores in the lining of the large intestine, which can lead to symptoms like abdominal pain and diarrhea. The study aims to evaluate how effective and safe Vedolizumab is when used as a long-term treatment for those who have shown improvement after initial treatment with the same medication.

Participants in the study will receive Vedolizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will compare two different dosing schedules of Vedolizumab to see which is more effective in maintaining remission, which means keeping the disease under control without symptoms. The study will last for about 54 weeks, during which the participants’ health and response to the treatment will be closely monitored. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of Vedolizumab.

Throughout the study, the participants’ progress will be assessed using a scoring system that measures various symptoms of Ulcerative Colitis, such as stool frequency and rectal bleeding. The goal is to determine if Vedolizumab can help achieve and maintain remission in young patients with moderate to severe Ulcerative Colitis. The study will also look at the safety of the medication by monitoring any side effects or adverse reactions that may occur during the treatment period.

1 initial treatment phase

Upon joining the study, the initial treatment involves receiving vedolizumab through an intravenous infusion. This medication is administered to help manage symptoms of moderately to severely active ulcerative colitis.

The dosage of vedolizumab is 300 mg, and it is given as a solution for infusion. The frequency and duration of this initial phase are determined by the study protocol.

2 maintenance therapy

After the initial treatment phase, the study evaluates the effectiveness of vedolizumab as a maintenance therapy. This involves continued administration of the medication to maintain symptom control.

The primary goal is to achieve clinical remission by Week 54, which means a significant reduction in symptoms such as stool frequency and rectal bleeding.

3 monitoring and assessments

Throughout the study, regular monitoring and assessments are conducted to evaluate the response to treatment. This includes checking for clinical remission at various intervals, such as Weeks 14 and 54.

Safety assessments are also performed to monitor any adverse effects or reactions to the medication.

4 completion of study

The study is expected to conclude by August 2025. At the end of the study, the overall effectiveness and safety of vedolizumab as a maintenance therapy for pediatric subjects with ulcerative colitis will be evaluated.

Final assessments will determine if the treatment has successfully maintained clinical remission and improved quality of life for participants.

Who Can Join the Study?

  • The child must be between 2 and 17 years old at the time of joining the study.
  • The child must weigh at least 10 kilograms when joining the study.
  • The child must have been diagnosed with Ulcerative Colitis (UC), a condition affecting the colon, at least one month before joining the study. The UC should be moderately to severely active, which is determined by a specific scoring system called the Mayo score.
  • The child must have tried and not responded well to, or not tolerated, at least one of the following treatments: corticosteroids (a type of medication that reduces inflammation), immunomodulators (medications like AZA, 6-MP, MTX that help control the immune system), or TNF-α antagonist therapy (medications like infliximab, adalimumab that target specific proteins in the body).
  • The child must have UC that affects more than just the rectum, meaning it extends further into the colon.
  • If the child has had extensive colitis (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, there must be proof of a recent colonoscopy showing no signs of cancer within the last year.
  • The child must be up-to-date with 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 Ulcerative Colitis (UC) cannot participate. UC is a condition that causes inflammation and sores in the colon and rectum.
  • Patients who are not within the specified age range for the study cannot participate. The study is for a specific age group.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other health conditions that might interfere with the study cannot participate.
  • Patients who are taking certain medications that might affect the study results cannot participate.
  • Patients who have had recent surgeries or medical procedures that might affect the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of certain infections or diseases that might affect the study cannot participate.
  • Patients who have participated in other clinical trials recently cannot participate.
  • Patients who have allergies or reactions to the study medication cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
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
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Azienda Ospedaliera di Padova Padua Italy
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
Uobeobaknm Oh Akeuwdw Edegem Belgium
Ulidgaxcou Dwrfb Sliaa Dj Rhsp Lf Sulhkhqs Rome Italy
Wag Wanaqr Imt Pdyqp Ppkthkqr Ksnnocw Warsaw Poland
Undjsbbhuv Gthtnjz Hakrbpiz Anhhxrl Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
07.05.2021
Croatia Croatia
Not recruiting
07.05.2021
Greece Greece
Not recruiting
07.05.2021
Hungary Hungary
Not recruiting
07.05.2021
Italy Italy
Not recruiting
07.05.2021
Poland Poland
Not recruiting
07.05.2021

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 ulcerative colitis. It is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The goal of using vedolizumab in this study is to see if it can help keep the symptoms of ulcerative colitis under control over a long period, specifically aiming for clinical remission by the 54th week of treatment.

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 colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of flare-ups and remissions. During flare-ups, symptoms can become more severe, while remissions may bring relief. The exact cause of Ulcerative Colitis is not fully understood, but it is believed to involve an abnormal immune response. Environmental factors and genetics may also play a role in its development.

Trial ID:
2023-509018-12-00
Protocol code:
MLN0002-3024
NCT ID:
NCT04779307
Trial Phase:
Therapeutic confirmatory (Phase III)

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