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Vedolizumab Subcutaneous Long-term Open-label Extension Study in Pediatric Subjects
EU CTIS ID: 2023-508804-39-00
What this study is testing
The primary objective of the treatment cohort is to evaluate the safety profile of long-term vedolizumab SC 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
- 01. 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
- 02. The subject, subject’s legally authorized representative or adult caregiver signs and dates a written treatment cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations
- 03. The subject is male or female with UC or CD and aged <18 years. (Note: subjects who reach adult age [18 years 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)
- 04. The subject completed Week 34 of Study VedolizumabSC-3003 and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for subjects with UC is defined as a reduction of partial Mayo score of ≥2 points and ≥25% from baseline (from VedolizumabSC-3003), including a ≥1-point decrease in the Mayo stool frequency subscore and a ≥1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of ≤1 point. Clinical response for subjects with CD is defined as a PCDAI ≤30 with a reduction in the PCDAI of ≥15 points from baseline (from VedolizumabSC-3003)
- 05. 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 spermicide) from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after the last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception
- 06. A female subject of childbearing potential who is sexually active with a non-sterilized 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 for 18 weeks after the last dose
You likely can't join if
- 01. The subject is female and is lactating or pregnant
- 02. The subject has hypersensitivity or allergies to vedolizumab or any of its excipients
- 03. 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
- 04. The subject developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, 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 subject safety.
- 05. The subject has other serious comorbidities that will limit their ability to complete the study
- 06. The subject is unable to comply with all study assessments
See the full eligibility criteria
Who can join
- 01. 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
- 02. The subject, subject’s legally authorized representative or adult caregiver signs and dates a written treatment cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations
- 03. The subject is male or female with UC or CD and aged <18 years. (Note: subjects who reach adult age [18 years 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)
- 04. The subject completed Week 34 of Study VedolizumabSC-3003 and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for subjects with UC is defined as a reduction of partial Mayo score of ≥2 points and ≥25% from baseline (from VedolizumabSC-3003), including a ≥1-point decrease in the Mayo stool frequency subscore and a ≥1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of ≤1 point. Clinical response for subjects with CD is defined as a PCDAI ≤30 with a reduction in the PCDAI of ≥15 points from baseline (from VedolizumabSC-3003)
- 05. 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 spermicide) from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after the last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception
- 06. A female subject of childbearing potential who is sexually active with a non-sterilized 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 for 18 weeks after the last dose
- Observational Cohort: 01. The subject, subject’s legally authorized representative or adult caregiver signs and dates a written observational cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations.
- Observational Cohort: 02. The subject has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 but was not eligible to enroll in the treatment cohort of this study
What rules you out
- 01. The subject is female and is lactating or pregnant
- 02. The subject has hypersensitivity or allergies to vedolizumab or any of its excipients
- 03. 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
- 04. The subject developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, 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 subject safety.
- 05. The subject has other serious comorbidities that will limit their ability to complete the study
- 06. The subject is unable to comply with all study assessments
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
- Japan
- Serbia
- Korea, Republic of
- Taiwan
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 States; Switzerland; Japan; Serbia; Korea, Republic of; Taiwan. 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.