Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
5-17 years
Phase:
PHASE4
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 re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.
- 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)
Key Trial Info
Start Date :
June 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05976802
Start Date
June 1 2027
End Date
January 1 2030
Last Update
September 18 2025
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