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A Long-term Study in Children and Teenagers with Ulcerative Colitis or Crohn’s Disease treated with Vedolizumab IV
EU CTIS ID: 2023-509046-36-00
What this study is testing
The primary objective of the treatment cohort is to evaluate the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. In the opinion of the investigator, the subject, or subject`s legally authorized representative, subject`s parent, or legal guardian (adult caregiver) is capable of understanding and complying with protocol requirements.
- 2. The subject, subject’s legally authorized representative or adult caregive signs and dates a written, informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations.
- The subject is male or female with UC or CD and aged <18 years. (Note: Subjects who reach adult age [18 years of age in most jurisdictions/regions] during the study should be considered to transition to commercial drug if available in their country, especially if transition to an adult care setting is required by local regulation.).
- The subject has completed Study MLN0002-3024 or Study MLN0002-3025 and has 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 subjects with UC; or a reduction of PCDAI of ≥15 points for subjects with CD from baseline of the parent study and with total PCDAI ≤30.
- 5. A male subject who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (eg, condom with or without spermicide) from signing of subject/ 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 subject should also be advised to use a highly effective method of contraception.
- 6. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
You likely can't join if
- Treatment Cohort only: The subject is female and is lactating or pregnant.
- The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.
- The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, 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 subject safety.
- The subject has other serious comorbidities that will limit their ability to complete the study.
- The subject is unable to comply with all study assessments.
See the full eligibility criteria
Who can join
- 1. In the opinion of the investigator, the subject, or subject`s legally authorized representative, subject`s parent, or legal guardian (adult caregiver) is capable of understanding and complying with protocol requirements.
- 2. The subject, subject’s legally authorized representative or adult caregive signs and dates a written, informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations.
- The subject is male or female with UC or CD and aged <18 years. (Note: Subjects who reach adult age [18 years of age in most jurisdictions/regions] during the study should be considered to transition to commercial drug if available in their country, especially if transition to an adult care setting is required by local regulation.).
- The subject has completed Study MLN0002-3024 or Study MLN0002-3025 and has 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 subjects with UC; or a reduction of PCDAI of ≥15 points for subjects with CD from baseline of the parent study and with total PCDAI ≤30.
- 5. A male subject who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (eg, condom with or without spermicide) from signing of subject/ 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 subject should also be advised to use a highly effective method of contraception.
- 6. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
- Main Criteria for Inclusion in the Observational Cohort: The subject, parent, or legal guardian signs and dates a written, informed consent form.
- The subject 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.
What rules you out
- Treatment Cohort only: The subject is female and is lactating or pregnant.
- The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.
- The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, 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 subject safety.
- The subject has other serious comorbidities that will limit their ability to complete the study.
- The subject is unable to comply with all study assessments.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- China
- Canada
- Australia
- Israel
- United States
- Japan
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; China; Canada; Australia; Israel; United States and 1 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 EU CTIS; the study team decides eligibility.