Vedolizumab IV in Pediatric Participants With Ulcerative Colitis or Crohn's Disease
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease|
- AUCweek 14: Area Under the Serum Concentration-time Curve from Day 1 to Week 14 [ Time Frame: Days 1 post-dose and at multiple timepoints (up to Week 14) post-dose ]
- Cav, week 14: Average Serum Concentration During a Dosing Interval at Week 14 [ Time Frame: Days 1 post-dose and at multiple timepoints (up to Week 14) post-dose ]
- Ctrough, week 14: Observed Serum Concentration at the end of a Dosing Interval at Week 14 [ Time Frame: Week 14 post-dose ]
- Percentage of Ulcerative Colitis Participants who Achieve Clinical Response Based on Complete Mayo Score at Week 14 [ Time Frame: Week 14 ]Clinical response is defined as a reduction in complete Mayo score of ≥3-points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1-point or absolute rectal bleeding subscore of ≤1-point. Mayo score is used in clinical trials to assess ulcerative colitis disease activity. It consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
- Percentage of Crohn's Disease Participants who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Week 14 [ Time Frame: Week 14 ]Clinical response is defined as ≥70-point decrease from Baseline in CDAI score at Week 14. The CDAI evaluates severity of signs and symptoms of CD. Information will be 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 are combined with data from a 7-day diary to obtain total CDAI score. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease, values ≥220 indicates moderate to severe disease, and values above 450 are seen with extremely severe disease.
|Anticipated Study Start Date:||May 12, 2017|
|Estimated Study Completion Date:||November 4, 2020|
|Estimated Primary Completion Date:||December 2, 2019 (Final data collection date for primary outcome measure)|
Experimental: Vedolizumab High dose group
Participants with UC or CD having baseline weight of ≥30 kg will receive Vedolizumab 300 mg and participants with UC or CD having baseline weight of <30 kg will receive Vedolizumab 200 mg, intravenous (IV) infusion, on Day 1, Weeks 2, 6 and 14.
Vedolizumab intravenous infusion
Experimental: Vedolizumab Low dose group
Participants with UC or CD having baseline weight of ≥30 kg will receive Vedolizumab 150 mg and participants with UC or CD having baseline weight of <30 kg will receive Vedolizumab 100 mg, IV infusion, on Day 1 and Weeks 2, 6 and 14. Participants assigned to the low dose group who do not achieve clinical response (based on pediatric ulcerative colitis/Crohn's disease activity index) at Week 14 will receive vedolizumab IV high dose (ie, 300 mg for participants ≥30 kg baseline weight and 200 mg for participants <30 kg baseline weight).
Vedolizumab intravenous infusion
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). This study will look at the pharmacokinetics (PK), efficacy, immunogenicity, safety, and tolerability in participants who take vedolizumab.
The study will enroll approximately 80 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two dose regimens (high or low) per weight group 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 intravenous (IV) infusion. Participants assigned to the low dose group who do not achieve clinical response (based on pediatric ulcerative colitis/Crohn's disease activity index) at Week 14 will receive the high dose (ie, 300 mg for participants ≥30 kg baseline weight and 200 mg for participants <30 kg baseline weight) of vedolizumab IV 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 an 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03138655
|Contact: Takeda Study Registration Call Centeremail@example.com|
|Study Director:||Medical Monitor Clinical Science||Takeda|