|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Active Ulcerative Colitis (UC) or Crohn's disease (CD)
|Medical condition in easily understood language
|Active UC or CD. UC is a long-term condition that results in inflammation and ulcers of the colon and rectum. CD is a disease that causes inflammation of the digestive system.
|Diseases [C] - Digestive System Diseases [C06]
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|The primary objective of this study is to evaluate the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.
|Secondary objectives of the trial
|• 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.
|Trial contains a sub-study
|Principal inclusion criteria
|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 <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.).
4. 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.
5. A male subject who is sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (eg, condom with or without spermicide) from signing of informed consent 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 informed consent throughout the duration of the study and 18 weeks after the last dose.
|Principal exclusion criteria
|1. The subject is female and is lactating or pregnant.
2. The subject has hypersensitivity or allergies to any of the vedolizumab 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.
|E.5 End points
|Primary end point(s)
|The primary endpoint for this study is adverse events (AEs).
|Timepoint(s) of evaluation of this end point
|Once every 16 weeks until Week 48, thereafter once every 24 weeks.
|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.
|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.
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
|Different doses of IMP are used in treatment arms
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Korea, Republic of
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial years
|In all countries concerned by the trial days