Ulcerative Colitis (UC)
Conditions
Interventions
Subjects who weigh >=30 kg will receive vedolizumab IV 300 mg (high dose) or 150
mg (low dose) Q8W.
Subjects who weigh
Crohn's Disease (CD)
Ulcerative Colitis (UC)
Sponsors
Takeda
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - 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 criteria and 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
Exclusion criteria
Exclusion criteria: - 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 - The subject has withdrawn from Study MLN0002-2003.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study is percentage of subjects with treatment-emergent adverse events (TEAEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints for this study are: • Percentage of UC subjects who, at Week 32, achieve and maintain clinical response based on complete Mayo score, as defined by a continued reduction in complete Mayo score of >=3 points from the baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of >=1 point from baseline, or absolute rectal bleeding subscore of =70 point decrease from the baseline CDAI score at the initiation of MLN0002-2003. • Time to major IBD-related events (hospitalizations, surgeries, or procedures). • Changes from Baseline in IMPACT-III (where translations are available) total and subscale scores at Week 24 and every 24 weeks, thereafter. • Height velocity at Week 48 and every 48 weeks, thereafter. • Change from Baseline in height, weight, and body mass index (BMI) at Week 24 and every 24 weeks, thereafter. • Percentage of subjects achieving Tanner stage V at or before age 16 years (females) or 17 years (males). | — |
Countries
The Netherlands
Outcome results
None listed