Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis

NCT05976802 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: BFUC4991
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to \<12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with clinical remission

  Clinical remission based on the modified Mayo Clinic Score, defined as an endoscopy score ≤ 1 (excluding friability), a rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore ≤ 1. Each component is scored from 0 to 3, with total scores ranging from 0 to 9, with higher scores indicating more severe disease.

  Day 42

Secondary Outcomes (3)

• Proportion of participants who achieve a rectal bleeding subscale score of 0 at the end of six weeks of treatment

  Day 42

• Proportion of participants who achieve a stool frequency subscale score of 0 at the end of six weeks of treatment.

  Day 42

• Proportion of subjects who achieve an endoscopy subscale score of 0 or 1 at the end of six weeks of treatment.

  Day 42

Study Arms (3)

High dose budesonide rectal foam

EXPERIMENTAL

Drug: High dose budesonide rectal foam

Low dose budesonide rectal foam

EXPERIMENTAL

Drug: Low dose budesonide rectal foam

Matching placebo rectal foam

PLACEBO COMPARATOR

Drug: Matching placebo rectal foam

Interventions

High dose budesonide rectal foam DRUG

Twice a day for 2 weeks, then once a day for 4 weeks

High dose budesonide rectal foam

Low dose budesonide rectal foam DRUG

Twice a day for 2 weeks, then once a day for 4 weeks

Low dose budesonide rectal foam

Matching placebo rectal foam DRUG

Twice a day for 2 weeks, then once a day for 4 weeks

Matching placebo rectal foam

Eligibility Criteria

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

You may qualify if:

• Male and Female (non-pregnant and non-lactating) 5 to ≤17 years of age at Screening.
• Established diagnosis of UC, based on clinical history, characteristic endoscopic findings, and histopathology results from biopsies.
• Disease limited to the distal colon and rectum, (disease involving only the first 15 centimeters or less proximal to the anal verge).
• Active, distal UC of mild or moderate severity, defined as a Modified Mayo Clinic Score (mMCS) between 4 and 8, inclusive, that includes an endoscopy subscore ≥ 2 and a rectal bleeding subscore ≥ 1.
• If on a background oral 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (Run-In) and the subject is willing to remain on the same dosage form and regimen for the duration of the study.

You may not qualify if:

• Current or prior diagnosis of Crohn's disease or indeterminate colitis.
• Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and/or ascending colon and cecum;
• Severe UC, defined as an mMCS \> 8.
• Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days of Screening).
• Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).
• Evidence or history of toxic megacolon or bowel resection.
• Active proctologic pathology such as hemorrhoids, fistulas and fissures or other historical anatomic problems which would impair rectal administration (e.g., cloaca, imperforate anus history)

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Varsha Bhatt

  Bausch Health

  STUDY DIRECTOR

Central Study Contacts

Varsha Bhatt

CONTACT

707-285-1528; Varsha.Bhatt@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: July 28, 2023
• First Posted: August 4, 2023
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 18, 2025

Record last verified: 2025-09