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

NCT04314375 | Recruiting Phase 4 FDA Drug

• 1 other identifier: BUUC4991
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56.

  56 days

• Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56.

  56 days

• Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56.

  56 days

Study Arms (3)

Low Dose Budesonide

EXPERIMENTAL

Drug: Low Dose Budesonide

High Dose Budesonide

EXPERIMENTAL

Drug: High Dose Budesonide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low Dose Budesonide DRUG

3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.

Low Dose Budesonide

High Dose Budesonide DRUG

6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.

High Dose Budesonide

Placebo DRUG

Matching placebo once daily.

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Evidence or history of toxic megacolon or bowel resection.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (4)

Bausch Health Site 008

Garden Grove, California, 92845, United States

RECRUITING

Bausch Health Site 003

Indianapolis, Indiana, 46202, United States

RECRUITING

Bausch Health Site 006

The Bronx, New York, 10467, United States

RECRUITING

Bausch Health Site 010

Greenville, North Carolina, 27834, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Varsha Bhatt

  Bausch Health

  STUDY DIRECTOR

Central Study Contacts

Sandra Narain

CONTACT

9082428287; sandra.narain@bauschhealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: September 29, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (4)