A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Takeda
Summary
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.
Description
This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 \[participants with UC\] and MLN0002-3025 \[participants with CD\], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort. Treatment Cohort: The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD. Pa…
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria: For Treatment Cohort: 1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30. 2. A male participant who is sexually active with a female partner of childbeari…
Interventions
- DrugVedolizumab IV
Vedolizumab IV infusion
- OtherNo Intervention
Participants will not receive any intervention in the Observational Cohort.
Locations (98)
- University of South Alabama (USA) Physicians GroupMobile, Alabama
- Phoenix Childrens Hospital - Thomas Rd - PINPhoenix, Arizona
- Cedars Sinai Medical Center - 127 San Vicente BlvdLos Angeles, California
- Rady Children's Hospital - San Diego - PINSan Diego, California
- University of California San FranciscoSan Francisco, California
- I.H.S Health LLC-Kissimmee-445 W Oak StKissimmee, Florida