Active Ulcerative Colitis (UC) or Crohn's disease (CD)
Conditions
Sponsors
Takeda Development Center Americas, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Criteria for Inclusion in the Treatment Cohort: 1. In the opinion of the investigator, the subject, parent, or legal guardian is capable of understanding and complying with protocol requirements. 2. The subject, parent, or legal guardian signs and dates a written, informed consent form and any required privacy authorization before the initiation of any study procedures. 3. The subject is male or female with UC or CD and aged =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Treatment Cohort only: 1. The subject is female and is lactating or pregnant. 2. The subject has hypersensitivity or allergies to vedolizumab or any of its excipients. 3. 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. 4. 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. 5. The subject has other serious comorbidities that will limit their ability to complete the study. 6. The subject is unable to comply with all study assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: for the Treatment Cohort: 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.;Secondary Objective: Secondary objectives for the Treatment Cohort: • To evaluate the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel disease (IBD)-related events (eg, hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD. • To evaluate quality of life in subjects aged 9 to 17 years who were treated with vedolizumab IV using the IMPACT-III questionnaire. Objectives for the Observational Cohort: • The objectives for the observational cohort are to assess prespecifed safety events of interest and monitor growth and pubertal development for approximately 2 years after the last dose of study drug in Studies MLN0002-3024 or MLN0002-3025. ;Primary end point(s): The primary endpoint for this study is the incidence of adverse events (AEs).;Timepoint(s) of evaluation of this end point: Once every 16 weeks until Week 48, thereafter once every 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures). • Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured every 24 weeks. Endpoints for the Observational Cohort: • Incidence of prespecified safety events (serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery). • Change from Study MLN0002-3029 baseline (Day 1) in weight and linear growth z-score up to 2 years after the last dose of vedolizumab in Study MLN0003-3024 or Study MLN0003-3025. • Percentage of subjects achieving Tanner Stage V based on progression of pubertal changes from baseline.;Timepoint(s) of evaluation of this end point: Time to major IBD-related events - through-out duration of the study. Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured - every 24 weeks. Endpoints for the Observational Cohort: • Incidence of prespecified safety events (serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery). • Change from Study MLN0002-3029 baseline (Day 1) in weight and linear growth z-score up to 2 years after the last dose of vedolizumab in Study MLN0003-3024 or Study MLN0003-3025. • Percentage of subjects achieving Tanner Stage V based on progression of pubertal changes from baseline. | — |
Countries
Australia, Belgium, Canada, China, Croatia, Czechia, Czech Republic, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Poland, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactDirector, Clinical Operations
Takeda Development Center Americas, Inc.
Outcome results
None listed