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An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn's Disease
EU CTIS ID: 2023-507766-35-00
What this study is testing
To determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.
- Therapeutic exploratory (Phase II)
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
- The subject is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of their randomization in Study MLN0002-2003. (Note: A subject remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteriaand do not meet any exclusion criteria)
- The subject completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from Baseline, or a reduction of the PUCAI of ≥20 points from baseline for subjects with UC; or a reduction of the CDAI as defined by a ≥70-point decrease from Baseline or a decrease of PCDAI of ≥15 points for subjects with CD
- The subject may be receiving a therapeutic dose of the following drugs:Oral 5-aminosalicylic (5-ASA) compounds; Oral corticosteroid therapy (prednisone or equivalent steroid at a dose ≤50 mg/day);Topical (rectal) treatment with 5-ASA or corticosteroids; Probiotics (eg, Saccharomyces boulardii);Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea; Antibiotics used for treatment of CD (eg, ciprofloxacin, metronidazole);Azathioprine, 6-mercaptopurine, or methotrexate provided the subject was receiving this medication during prior participation in Study MLN0002-2003.
You likely can't join if
- The subject is female and is lactating or pregnant.
- The subject has hypersensitivity or allergies to vedolizumab or any of its excipients
- The subject has withdrawn from Study MLN0002-2003.
- 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 a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
- 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.
See the full eligibility criteria
Who can join
- The subject is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of their randomization in Study MLN0002-2003. (Note: A subject remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteriaand do not meet any exclusion criteria)
- The subject completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from Baseline, or a reduction of the PUCAI of ≥20 points from baseline for subjects with UC; or a reduction of the CDAI as defined by a ≥70-point decrease from Baseline or a decrease of PCDAI of ≥15 points for subjects with CD
- The subject may be receiving a therapeutic dose of the following drugs:Oral 5-aminosalicylic (5-ASA) compounds; Oral corticosteroid therapy (prednisone or equivalent steroid at a dose ≤50 mg/day);Topical (rectal) treatment with 5-ASA or corticosteroids; Probiotics (eg, Saccharomyces boulardii);Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea; Antibiotics used for treatment of CD (eg, ciprofloxacin, metronidazole);Azathioprine, 6-mercaptopurine, or methotrexate provided the subject was receiving this medication during prior participation in Study MLN0002-2003.
What rules you out
- The subject is female and is lactating or pregnant.
- The subject has hypersensitivity or allergies to vedolizumab or any of its excipients
- The subject has withdrawn from Study MLN0002-2003.
- 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 a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
- 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 other serious comorbidities that will limit their ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- United States
- Israel
- Ukraine
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 Canada; United Kingdom; United States; Israel; Ukraine. 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.