RECRUITING

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

Talk to us

Conditions

Ulcerative ColitisCrohn's DiseaseDrug Therapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease

Quick Facts

Study Start:2023-05-16
Study Completion:2031-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05442567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. A male participant who is sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (e.g., condom with or without spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
  3. 3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and 18 weeks after the last dose.
  4. 1. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.
  1. 1. The participant currently requires 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.
  2. 2. The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  3. 3. The participant has other serious comorbidities that will limit their ability to complete the study.
  4. 4. The participant is unable to comply with all study assessments.
  5. 5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
  6. 6. The participant is lactating or pregnant.

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Phoenix Childrens Hospital -1919 E Thompson Rd
Phoenix, Arizona, 85016-7710
United States
Rady Childrens Hospital San Diego - PIN
San Diego, California, 92123-4223
United States
Childrens Center For Digestive Healthcare
Atlanta, Georgia, 30342
United States
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, 60068
United States
Johns Hopkins University
Baltimore, Maryland, 21287-0005
United States
Boston Children's Hospital
Boston, Massachusetts, 02115-5724
United States
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, 55413
United States
Mayo Clinic - PIN
Rochester, Minnesota, 55905-0001
United States
Goryeb Children's Hospital
Morristown, New Jersey, 07960-6136
United States
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
New Hyde Park, New York, 11042-2062
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15201
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
Carilion Children's Tanglewood Center
Roanoke, Virginia, 24018-0720
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-16
Study Completion Date2031-08-15

Study Record Updates

Study Start Date2023-05-16
Study Completion Date2031-08-15

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Crohn's Disease