UCNot 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

Phase 4 · Testing High dose budesonide rectal foam and Low dose budesonide rectal foam · Sites not listed yet · Bausch Health Americas, Inc.

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing High dose budesonide rectal foam (a drug) and Low dose budesonide rectal foam (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.

Who can join

Ages 5 to 17
Any sex

Some of the main requirements, copied from the record:

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.

There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 100 participants are expected to take part.
The study has 3 groups.
Start date: 2029-06 (planned).
Main results expected around 2030-06 (estimate from the record).
No study sites are listed yet. Check the official record for contact details.

Groups in this study

High dose budesonide rectal foam (listed as: experimental group)
Low dose budesonide rectal foam (listed as: experimental group)
Matching placebo rectal foam (listed as: placebo group)

Main thing being measured

Proportion of participants with clinical remission (Day 42)

In the researchers’ words

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).

Words you might see

Placebo: a look-alike pill or injection with no active drug, used for comparison.
Endoscopy: a camera exam inside the digestive tract.
Mayo score: a score used to measure how active ulcerative colitis is.
Remission: a period when the disease is quiet or under control.
Induction: the first phase of treatment, aimed at getting the disease under control.
Fistula: an abnormal tunnel between two parts of the body, which can happen in Crohn's disease.
Biopsy / histology: a small tissue sample examined under a microscope.

General definitions, not specific to this trial.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional
Conditions	Ulcerative Colitis
Lead sponsor	Bausch Health Americas, Inc.
Enrollment	100 (estimated)
Start date	2029-06
Primary completion (est.)	2030-06
First posted	2023-08-04
Last updated	2026-10-06
Official title	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
ClinicalTrials.gov ID	NCT05976802

Interventions

High dose budesonide rectal foam (Drug)
Twice a day for 2 weeks, then once a day for 4 weeks
Low dose budesonide rectal foam (Drug)
Twice a day for 2 weeks, then once a day for 4 weeks
Matching placebo rectal foam (Drug)
Twice a day for 2 weeks, then once a day for 4 weeks

Full eligibility criteria (from the record)

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)

Locations (0)

No sites listed yet. The official record has contact information.

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.