Long-term safety study of subcutaneous vedolizumab in children and adolescents with ulcerative colitis or Crohn’s disease

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What is this study about?

This study focuses on two inflammatory bowel conditions: Ulcerative Colitis and Crohn’s Disease, which cause inflammation in different parts of the digestive system. The medication being tested is called vedolizumab, which is given as an injection under the skin using either a pre-filled syringe or pen device. The purpose is to evaluate the long-term safety of this treatment in children and teenagers under 18 years of age who have previously responded well to the medication.

The medication will be administered as a solution for injection containing 108 mg of vedolizumab. During the study, participants will receive regular injections of the medication for up to 24 months. The study will monitor how well children and teenagers tolerate long-term treatment with vedolizumab and track any side effects that may occur.

Throughout the study, doctors will watch for any health-related events and track the effectiveness of the treatment. They will pay special attention to how the medication affects the participants’ daily lives and overall well-being. The study includes regular check-ups to monitor the participants’ health and assess how well the digestive conditions are being controlled by the treatment.

1 Initial participation

If you are under 18 years old and have completed Week 34 of the previous study (VedolizumabSC-3003), you may be eligible to participate in this extended study

You must have achieved clinical response at Week 34 and been free from corticosteroids for at least 4 weeks (Week 30 to Week 34)

2 Treatment administration

You will receive Entyvio (vedolizumab) through subcutaneous injection

The medication will be provided in either a pre-filled syringe or pre-filled pen, containing 108 mg of the medicine

3 Safety monitoring

Your health will be monitored for any side effects or reactions to the medication

Special attention will be paid to infections, liver-related issues, and injection site reactions

Regular checks will be performed to monitor your response to treatment

4 Long-term follow-up

The study will track your progress to evaluate how well the medication works over time

If you have inflammatory bowel disease (IBD), any related events such as hospitalizations or procedures will be recorded

If you are between 9 and 17 years old, your quality of life will be assessed using special questionnaires

5 Study completion

The study is expected to continue until August 2030

Upon reaching 18 years of age, you may transition to regular medication if available in your country

Who Can Join the Study?

  • Patient must be under 18 years old and diagnosed with Ulcerative Colitis (UC) or Crohn’s Disease (CD)
  • Patient and/or their legal guardian must be able to understand and follow study requirements
  • Patient and/or their legal guardian must sign informed consent forms before any study procedures begin
  • Patient must have completed Week 34 of the previous study (VedolizumabSC-3003) and achieved:
    • For UC patients: improvement in bowel symptoms, including reduced stool frequency and bleeding
    • For CD patients: improvement in disease activity scores
  • Patient must be free from corticosteroids (a type of anti-inflammatory medication) for at least 4 weeks before Week 34
  • Male patients who are sexually active must agree to use barrier contraception (such as condoms) during the study and for 18 weeks after the last dose
  • Female patients who can become pregnant and are sexually active must use effective contraception during the study and for 18 weeks after the last dose
  • For observation group only:
    • Patient must have received at least one dose of vedolizumab in the previous study
    • Patient either left the previous study early or completed Week 34 but does not qualify for the treatment group

Who Cannot Join the Study?

  • Previous unsuccessful treatment with vedolizumab (a medication that reduces inflammation in the digestive tract)
  • Active or history of serious infections, including:
    • Tuberculosis (TB)
    • Severe viral infections
    • Parasitic infections
  • History of cancer or pre-cancerous conditions
  • Serious heart, liver, or kidney problems
  • Current pregnancy or breastfeeding
  • Use of other biological medications for treating inflammatory bowel disease within the past 60 days
  • Known allergies to vedolizumab or any of its components
  • Participation in other clinical trials within the past 30 days
  • Any surgical procedures planned during the study period
  • Presence of serious digestive tract infections
  • Inability to comply with study procedures and follow-up visits
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Spitalul Clinic de Copii “Dr. Victor Gomoiu” Bucharest Romania
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
Hospital Universitario 12 De Octubre Madrid Spain
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev Sofia Bulgaria
Area Sanitaria De Ferrol Ferrol Spain
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Azienda Sanitaria Locale Di Pescara Pescara Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Stichting Radboud University Medical Center Nijmegen The Netherlands
CHC MontLegia Liege Belgium
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Children’s Health Ireland Dublin Ireland
MD Korczowski Bartosz Gabinet Lekarski Rzeszow Poland
Cbannhfmv Uwlnsjmwvnlada Smsikupmx Woluwe-Saint-Lambert Belgium
Snrzsihh Cjflms Do Uwtjmhw Pdnbmf Cujfp Gmbbacv Awmxssgnmewj Bucharest Romania
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Hulcgo Hsphuhwd Herlev Denmark
Wgx Wcxrbm Idn Pklzf Pveyhphf Kactgdx Warsaw Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
05.07.2025
Bulgaria Bulgaria
Not yet recruiting
05.07.2025
Denmark Denmark
Not yet recruiting
05.07.2025
Ireland Ireland
Not yet recruiting
05.07.2025
Italy Italy
Not yet recruiting
05.07.2025
Poland Poland
Recruiting
05.07.2025
Portugal Portugal
Not yet recruiting
05.07.2025
Romania Romania
Recruiting
05.07.2025
Spain Spain
Not yet recruiting
05.07.2025
The Netherlands The Netherlands
Not yet recruiting
05.07.2025

Trial locations

Investigated drugs:

Vedolizumab is a medication given by injection under the skin (subcutaneous) that helps treat ulcerative colitis and Crohn’s disease. It works by blocking certain proteins in the body that cause inflammation in the digestive tract. This medication helps reduce symptoms like abdominal pain, diarrhea, and bleeding by decreasing inflammation in the intestines.

Investigated diseases:

Ulcerative Colitis – A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract’s innermost lining. It typically begins gradually and can become worse over time, causing continuous inflammation in some areas of the colon. The disease can cause recurring episodes of abdominal pain, diarrhea, and changes in bowel habits.

Crohn’s Disease – A chronic inflammatory condition that can affect any part of the digestive tract from mouth to anus, but most commonly involves the small intestine and beginning of the large intestine. The inflammation extends deep into the layers of affected bowel tissue. The disease commonly occurs in patches, with healthy sections in between affected areas. It can cause abdominal pain, diarrhea, fatigue, and weight loss.

Trial ID:
2023-508804-39-00
Protocol code:
VedolizumabSC-3004
NCT ID:
NCT06405087
Trial Phase:
Therapeutic confirmatory (Phase III)

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