The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD. This study will look at the PK, efficacy, immunogenicity, safety, and tolerability in participants who take vedolizumab. The study will enroll approximately 80 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two dose regimens (high or low) per weight group \>=30 kg and 10 kg to \<30 kg in ratio 1:1-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Vedolizumab high dose group - Vedolizumab 300 mg or 200 mg * Vedolizumab low dose group - Vedolizumab 150 mg or 100 mg All participants will be administered vedolizumab via IV infusion. Participants assigned to the low dose group who do not achieve clinical response (based on pediatric UC/CDAI) at Week 14 will receive the high dose (that is, 300 mg for participants \>=30 kg baseline weight and 200 mg for participants 10 kg to \<30 kg baseline weight) of vedolizumab IV at Week 14. Participants assigned to the high dose group who had not achieved clinical response continued on the same blinded high dose at Week 14. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 36 weeks. After completing the Week 22 Visit procedures, eligible participants may enter a blinded extension study. Participants will make multiple visits to the clinic, and those who do not enter extension study will have a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants who do not enter the extension study will also participate in a long-term safety follow-up, by telephone, 6 months after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
Vedolizumab IV infusion.
AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14
Time frame: From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)
Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14
Time frame: From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)
Ctrough,Week 14: Observed Serum Concentration at the End of a Dosing Interval at Week 14
Time frame: At the end of a dosing interval at Week 14
Percentage of UC Participants Who Achieve Clinical Response Based on Complete Mayo Score
Clinical response was defined as a reduction in complete Mayo score of \>= 3 points and \>=30 % from Baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point(s) or absolute rectal bleeding sub-score of \<= 1 point. Mayo score was used in to assess UC disease activity. It consisted of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale was scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranged from 0 to 12, with higher scores indicating more severe disease.
Time frame: Baseline (Day 1) and Week 14
Percentage of CD Participants Who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI)
Clinical response was defined as \>=70 points decrease from Baseline in CDAI score at Week 14. The CDAI evaluated severity of signs and symptoms of CD. Information was collected on number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory, yielding 8 items that were combined with data from a 7-day diary to obtain total CDAI score. Index values of 150 and below were associated with quiescent disease; values above that indicated active disease, values \>=220 indicated moderate to severe disease, and values above 450 were seen with extremely severe disease.
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Nemours Children's Clinic
Wilmington, Delaware, United States
Nemours Childrens Specialty Care - Jacksonville
Jacksonville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University School of Medicine - Indianapolis
Indianapolis, Indiana, United States
...and 78 more locations
Time frame: Baseline (Day 1) and Week 14