MLN0002-3024

Recruitment Complete

A Study of Vedolizumab in Children and Teenagers with Moderate to Severe Ulcerative Colitis (UC)

Clinicaltrials.gov

EudraCT

#2020-004300-34

jRCT

#jRCT2071210030

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

11+

Interventional Phase 3 clinical trial.

See if you qualify

What medical conditions were being studied?

Ulcerative Colitis

What was the clinical trial testing?

Vedolizumab

How many participants were enrolled?

121

Were placebos part of the clinical trial?

When was the clinical trial conducted?

Apr 2022 - Aug 2025

How long was participation in the clinical trial?

Participants will be treated with vedolizumab for up to about 1 year. They will be followed-up for another 2 years.

Sexes

All

Age

2 to 17 Years

Healthy volunteers?

Both boys and girls can take part

Must be a child or teenager from 2 to 17 years old ≥ 10 kg weight.

Must have moderate to severe ulcerative colitis.

Must have up-to-date vaccinations.

Must have not responded well enough or tolerated other medicines used to treat Ulcerative Colitis (e.g corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists.

Cannot have previously been treated with vedolizumab or other anti-integrins. Examples are natalizumab, efalizumab, etrolizumab, or rituximab. Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Percentage of Participants with Clinical Remission at Week 54 Based on Modified Mayo Score [Time Frame: Week 54]

Secondary outcome measures

Percentage of Participants with Clinical Remission at Week 14 Based on Modified Mayo Score [Time Frame: Week 14]

Percentage of Participants with Sustained Clinical Remission at Week 14 Based on Modified Mayo Score [Time Frame: Week 14]

Percentage of Participants with Sustained Clinical Remission at Week 54 Based on Modified Mayo Score [Time Frame: Week 54]

Percentage of Participants with Sustained Endoscopic Remission at Week 14 [Time Frame: Week 14]

Percentage of Participants with Sustained Endoscopic Remission at Week 54 [Time Frame: Week 54]

Percentage of Participants with Endoscopic Response at Week 14 [Time Frame: Week 14]

Percentage of Participants with Endoscopic Response at Week 54 [Time Frame: Week 54]

Percentage of Participants with Corticosteroid-free Clinical Remission at Week 54 [Time Frame: Week 54]

Percentage of Participants with Clinical Remission at Week 54 Based on Complete Mayo Score [Time Frame: Week 54]

Serum Trough Concentrations of Vedolizumab over Time [Time Frame: Predose and postdose at multiple time points (up to 54 weeks)]

Percentage of Participants with Positive Anti-vedolizumab Antibodies (AVA) [Time Frame: Predose (up to 54 weeks)]

Percentage of Participants with Positive Neutralizing AVA [Time Frame: Predose (up to 54 weeks)]

Percentage of Participants with Sustained Clinical Response at Week 14 Based on Complete Mayo Score [Time Frame: Week 14]

Percentage of Participants with Sustained Clinical Response at Week 54 Based on Complete Mayo Score [Time Frame: Week 54]

Percentage of Participants with Clinical Response up to Week 54 Based on Partial Mayo Score [Time Frame: Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54]

Percentage of Participants with Clinical Remission up to Week 54 Based on Partial Mayo Score [Time Frame: Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54]

Percentage of Participants with at least One Adverse Event (AE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) [Time Frame: Up to 158 weeks]

Change from Baseline in Weight [Time Frame: Baseline, up to Week 54]

Change from Baseline in Linear Growth Z-score [Time Frame: Baseline, up to Week 54]

Change in Tanner Stage at Week 54 Compared with Baseline [Time Frame: Week 54]

Recruiting

Ulcerative Colitis, Crohn's Disease

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

A Study of Vedolizumab in Children and Teenagers with Moderate to Severe Ulcerative Colitis (UC)

About this clinical trial

At a glance