A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 2 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 54 visits
- Time periods mentioned: 1 week, 5 years, 2 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant."
- "The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first."
- "The overall time to participate in the Observational Cohort is up to approximately 2 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study checks the long-term safety of vedolizumab in children with ulcerative colitis (UC) or Crohn’s disease (CD), which cause swelling in the gut. Children must have taken part in one of two earlier studies of this medicine.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- To join the treatment group, children must have finished study MLN0002-3024 or MLN0002-3025 and met the improvement rules at week 54.
- For the treatment group, children must have been off steroid medicines for at least 12 weeks before week 54, if they used them.
- For UC, the partial Mayo score, which measures disease symptoms, must have dropped by at least 2 points and 25% from the starting score.
- For CD, the pediatric Crohn’s disease activity score must have dropped by at least 15 points and be 30 or lower.
- In the treatment group, sexually active males with a female partner who could become pregnant must use condoms or another barrier method from study consent through 18 weeks after the last dose. Their partner should also be advised to use highly effective birth control.
- In the treatment group, females who could become pregnant and have sex with a male partner who has not been sterilized must use highly effective birth control from study consent through 18 weeks after the last dose.
- To join the observation group, children must have received at least one dose of vedolizumab in either earlier study. They must have left that study early, or finished the week 54 visit but not qualified for the treatment group.
Who can't join
- These rules apply only to the treatment group.
- Needs major surgery for UC or CD now, or is expected to need it during the study.
- Has a new health problem that is not stable or controlled and that the study doctor thinks could affect safety or study results.
- Has another serious illness that would limit the ability to finish the study.
- Cannot complete all required study tests and checks.
- Is allergic or sensitive to any added ingredient in vedolizumab.
- Is pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent 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. 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 participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose. For Observational Cohort: 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. Main Exclusion Criteria: For Treatment Cohort only: 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. 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. The participant has other serious comorbidities that will limit their ability to complete the study. 4. The participant is unable to comply with all study assessments. 5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients. 6. The participant is lactating or pregnant.
Study sites (22)
AL
- University of South Alabama (USA) Physicians Group · Mobile, AL 36604Site Contact · Study contactDavid Gremse · Principal investigatorMore trials in Mobile
AZ
- Phoenix Childrens Hospital - Thomas Rd - PIN · Phoenix, AZ 85016Site Contact · Study contactAshish Patel · Principal investigatorMore trials in Phoenix
CA
- Cedars Sinai Medical Center - 127 San Vicente Blvd · Los Angeles, CA 90048More trials in Los Angeles
- Rady Children's Hospital - San Diego - PIN · San Diego, CA 92123Site Contact · Study contactJeannie Huang · Principal investigatorMore trials in San Diego
- University of California San Francisco · San Francisco, CA 94158More trials in San Francisco
FL
- I.H.S Health LLC-Kissimmee-445 W Oak St · Kissimmee, FL 34741More trials in Kissimmee
GA
- Childrens Center For Digestive Healthcare · Atlanta, GA 30342Site Contact · Study contactBenjamin Gold · Principal investigatorMore trials in Atlanta
IL
- Advocate Children's Hospital - Park Ridge - PIN · Park Ridge, IL 60068Site Contact · Study contactKiranmai Gorla · Principal investigatorMore trials in Park Ridge
IN
- Riley Hospital For Children - PIN · Indianapolis, IN 46202More trials in Indianapolis
MA
- Boston Children's Hospital - PIN · Boston, MA 02215More trials in Boston
MD
- Johns Hopkins University · Baltimore, MD 21287More trials in Baltimore
MN
- MNGI Digestive Health PA-Plymouth · Minneapolis, MN 55413More trials in Minneapolis
- Mayo Clinic - PIN · Rochester, MN 55905More trials in Rochester
NJ
- Goryeb Children's Hospital · Morristown, NJ 07960More trials in Morristown
NY
- Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN · New Hyde Park, NY 11042More trials in New Hyde Park
- University of Rochester Medical Center - PPDS · Rochester, NY 14642More trials in Rochester
- Stony Brook University Medical Center · Stony Brook, NY 11794More trials in Stony Brook
OH
- University Hospitals Cleveland Medical Center - 11100 Euclid Ave · Cleveland, OH 44106Site Contact · Study contactThomas Sferra · Principal investigatorMore trials in Cleveland
PA
- UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN · Pittsburgh, PA 15201More trials in Pittsburgh
RI
- Hasbro Children's Hospital - PIN · Providence, RI 02903More trials in Providence
TX
- Texas Children's Hospital - Baylor - PIN · Houston, TX 77030Site Contact · Study contactFaith Ihekweazu · Principal investigatorMore trials in Houston
VA
- Carilion Children's Tanglewood Center · Roanoke, VA 24018Site Contact · Study contactMonica Garin-Laflam · Principal investigatorMore trials in Roanoke