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New treatment option for Ulcerative Colitis
Official title A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
ClinicalTrials.gov ID: NCT05442567
What this study is testing
What is Vedolizumab IV?
Vedolizumab IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ulcerative colitis.
Also referred to as MLN0002, ENTYVIO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Main For Treatment Cohort:
- The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has...
- A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g...
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of...
You likely can't join if
- For Treatment Cohort only:
- The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical...
- The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or...
- The participant has other serious comorbidities that will limit their ability to complete the study.
- The participant is unable to comply with all study assessments.
- The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
See the full eligibility criteria
- Main For Treatment Cohort:
- 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...
- 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...
- 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...
- For Treatment Cohort only:
- 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.
- 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...
- The participant has other serious comorbidities that will limit their ability to complete the study.
- The participant is unable to comply with all study assessments.
- The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
- The participant is lactating or pregnant.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Kissimmee, Florida, United States
- Atlanta, Georgia, United States
- Park Ridge, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Morristown, New Jersey, United States
- New Hyde Park, New York, United States
- Rochester, New York, United States
- Stony Brook, New York, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
+ 69 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Kissimmee, Florida, United States and 83 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.