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

NCT ID: NCT05976802

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-06-30
• Study Completion Date: 2030-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High dose budesonide rectal foam

Group Type: EXPERIMENTAL

High dose budesonide rectal foam

Intervention Type: DRUG

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

Low dose budesonide rectal foam

Group Type: EXPERIMENTAL

Low dose budesonide rectal foam

Intervention Type: DRUG

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

Matching placebo rectal foam

Group Type: PLACEBO_COMPARATOR

Matching placebo rectal foam

Intervention Type: DRUG

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

Interventions

High dose budesonide rectal foam

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

Intervention Type: DRUG

Low dose budesonide rectal foam

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

Intervention Type: DRUG

Matching placebo rectal foam

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and Female (non-pregnant and non-lactating) 5 to ≤17 years of age at Screening.

2. Established diagnosis of UC, based on clinical history, characteristic endoscopic findings, and histopathology results from biopsies.

3. Disease limited to the distal colon and rectum, (disease involving only the first 15 centimeters or less proximal to the anal verge).

4. 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.

5. 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.

Exclusion Criteria

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

2. Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and/or ascending colon and cecum;

3. Severe UC, defined as an mMCS > 8.

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

5. 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.

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

7. 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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Varsha Bhatt

Role: STUDY_DIRECTOR

Bausch Health

Central Contacts

Varsha Bhatt

Role: CONTACT

Varsha.Bhatt@bauschhealth.com

707-285-1528

Other Identifiers

BFUC4991

Identifier Type: -

Identifier Source: org_study_id