Phase 2
Completed N=89
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Ulcerative Colitis · Crohn's Disease
Source: ClinicalTrials.gov NCT03138655 ↗
Enrolled (actual)
89
Serious AEs
26.1%
Results posted
Dec 2020
Primary outcomePrimary: AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14 — 1933.5076; 3231.1001; 2344.4204; 3091.7957 h*ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14 |
1933.5076; 3231.1001; 2344.4204; 3091.7957; 2449.9433; 4182.4869 | — |
| PRIMARY Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14 |
39.3143; 61.2934; 46.8716; 63.6275; 44.6465; 77.2452 | — |
| PRIMARY Ctrough,Week 14: Observed Serum Concentration at the End of a Dosing Interval at Week 14 |
9.3100; 10.7226; 8.7395; 10.3685; 16.3645; 21.4860 | — |
| SECONDARY Percentage of UC Participants Who Achieve Clinical Response Based on Complete Mayo Score |
40.0; 66.7; 69.2; 41.7 | — |
| SECONDARY Percentage of CD Participants Who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI) |
63.6; 40.0; 45.5; 33.3 | — |
Eligibility Criteria
Inclusion Criteria
- Participants weighs >=10 kg at the time of randomization.
- Has a medical history of moderately to severely active UC during Screening defined as complete Mayo score of 6 to 12, and a total Mayo subscores of stool frequency and rectal bleeding >=4 and Mayo endoscopy subscore >=2, or has moderately to severely active CD defined as simple endoscopic score for Crohn's disease (SES-CD) >=7, and the CDAI components of average daily abdominal pain score of greater than (>) 1 for the 7 days prior, and total number of liquid/very soft stools >10 within 7 days prior to first dose of study drug.
- Has evidence of UC extending proximal to the rectum (that is, not limited to proctitis) or evidence of CD involving the ileum and/or colon, at a minimum.
- Has extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months prior to their first dose of study drug.
- Has a family history of colorectal cancer (that is, first-degree relative), personal history of increased colorectal cancer risk, or other known risk factor must be up-to-date on colorectal cancer surveillance.
- The participant's vaccinations are up to date.
- Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
Corticosteroids:
- Signs and/or symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to or more than prednisone 1 milligram per kilogram (mg/kg) daily orally for 2 weeks or IV for 1 week.
OR
- Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally on 2 separate occasions.
OR
- History of significant intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
Immunomodulators:
- Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (AZA) (>=1.5 milligram per kilogram per day [mg/kg/day]) or 6-mercaptopurine (6-MP) mg/kg (>=1.0 mg/kg/day) or methotrexate (MTX) (>=10 milligram per square meter [mg/m^2] once a week).
OR
- History of intolerance of at least 1 immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function test (LFT) abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, infection).
Tumor necrosis factor-alpha (TNF-α) antagonists:
- Signs and symptoms of persistently active disease despite a history of at least 1 induction regimen of infliximab 5 mg/kg IV at Week 0 and Weeks 2 and 6 or adalimumab 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15 if >=40 kg or 80 mg on Day 1 and 40 mg on Day 15 if =5 millimeter (mm). Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
- Clinically significant current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
- Has a current diagnosis of indeterminate colitis (Inflammatory bowel disease unclassified [IBDU]). For participants less than 6 years of age, any findings that suggest monogenic very early onset inflammatory bowel disease should be excluded.
- Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
- Has ileostomy, colostomy, ileo-anal pouch, or known fixed symptomatic stenosis of the intestine.
- Has extensive colonic resection, example, subtotal or total colectomy.
- Has a history or evidence of adenomatous colonic polyps that have not been removed.
- Has a history or evidence of colonic mucosal dysplasia.
- Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection. * HBV immune participants (that is, being hepatitis B surface antigen [HBs
Data sourced from ClinicalTrials.gov (NCT03138655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.