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

Clinicaltrials.gov

EudraCT

#2021-000630-34

jRCT

#jRCT2071230036

The study is an extension of two parent studies (MLN0002-3024 [NCT04779307] and MLN0002-3025 [NCT04779320]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.

12+

Interventional Phase 3 clinical trial.

See if you qualify

What medical conditions are being studied?

Ulcerative Colitis

Crohn's Disease

What is the clinical trial testing?

No Intervention, Vedolizumab IV

How many participants are being enrolled?

240

Are placebos part of the clinical trial?

When is the clinical trial being conducted?

May 2023 - Aug 2031

How long is participation in the clinical trial?

Each participant may be in the study for up to 5 years.

Sexes

All

Age

2+ Years

Healthy volunteers?

Must be a pediatric patient who participated in previous phase 3 vedolizumab studies with Crohn’s Disease or Ulcerative Colitis and achieved corticosteroid-free clinical response.

Cannot require major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.

Cannot have other serious illnesses or conditions that will limit their ability to complete the study.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Treatment Cohort: Number of Participants With at Least One Adverse Event (AE) [Time Frame: From first dose of study drug up to approximately 5 years]

Observational Cohort: Number of Participants With Prespecified Safety Events [Time Frame: Up to approximately 2 years]

Secondary outcome measures

Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events [Time Frame: Up to approximately 5 years]

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Total Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)]

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)]

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Systemic Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)]

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Social Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)]

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)]

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)]

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Time Frame: Baseline, every 24 weeks in this study (up to approximately 5 years)]