Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
Bausch Health Americas, Inc.
70 participants
Sep 29, 2023
INTERVENTIONAL
Conditions
Summary
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.
Eligibility
Inclusion Criteria7
- Established diagnosis of UC is based on:
- Clinical history
- Characteristic endoscopic findings
- Histopathology results from biopsies
- Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.
- Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1.
- If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study.
Exclusion Criteria8
- Current or prior diagnosis of Crohn's disease or indeterminate colitis.
- Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.
- Severe UC, defined as total Mayo score \>10.
- Not currently in an active phase or flare, defined as a total Mayo score \<4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy.
- Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).
- Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).
- NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.
- Evidence or history of toxic megacolon or bowel resection.
Interventions
3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.
6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.
Matching placebo once daily.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04314375