Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
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|ClinicalTrials.gov Identifier: NCT03138655|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Crohn's Disease||Drug: Vedolizumab||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||February 15, 2020|
|Estimated Study Completion Date :||December 3, 2020|
Experimental: Vedolizumab High dose group
Participants with UC or CD having baseline weight of >=30 kilogram (kg) will receive Vedolizumab 300 milligram (mg) and participants with UC or CD having baseline weight of 10 kg to less than (<) 30 kg will receive Vedolizumab 200 mg, intravenous (IV) infusion, on Day 1, Weeks 2, 6 and 14.
Vedolizumab IV 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 10 kg to <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 UC/CDAI) at Week 14 will receive vedolizumab IV high dose (that is, 300 mg for participants >=30 kg baseline weight and 200 mg for participants 10 kg to <30 kg baseline weight).
Vedolizumab IV infusion
- 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 UC 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 greater than or equal to (>=) 3-points and >=30 percent (%) from Baseline with an accompanying decrease in rectal bleeding subscore of >=1-point or absolute rectal bleeding subscore of less than or equal to (<=) 1-point. Mayo score is used in clinical trials to assess UC 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 CD 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138655
|Contact: Takeda Study Registration Call Centeremail@example.com|
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|Study Director:||Medical Monitor Clinical Science||Takeda|