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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314375
• Other study ID #: BUUC4991
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Bausch Health Americas, Inc.
• Contact: Sandra Narain
• Phone: 9082428287
• Email: sandra.narain[@]bauschhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

1. Current or prior diagnosis of Crohn's disease or indeterminate colitis.

2. Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.

3. Severe UC, defined as total Mayo score >10.

4. 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.

5. Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).

6. 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.

7. Evidence or history of toxic megacolon or bowel resection.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Low Dose Budesonide
3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.
• High Dose Budesonide
6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.
• Placebo
Matching placebo once daily.

Locations

Country	Name	City	State
United States	Bausch Health Site 006	Bronx	New York
United States	Bausch Health Site 008	Garden Grove	California
United States	Bausch Health Site 010	Greenville	North Carolina
United States	Bausch Health Site 003	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of = 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of = 1 for endoscopy.	The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of = 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of = 1 for endoscopy. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.	56 days
Secondary	Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56.	Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.	56 days
Secondary	Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56.	Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.	56 days
Secondary	Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56.	Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.	56 days