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New foam treatment could help kids with colitis avoid stronger drugs

NCT ID NCT05976802

Disease control Sponsor: Bausch Health Americas, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a steroid foam (budesonide) given rectally to children aged 5 to 17 with mild to moderate ulcerative colitis in the lower colon. The goal is to see if it can safely induce remission after 6 weeks of treatment. About 100 children will receive either a low dose, high dose, or placebo foam twice daily for 2 weeks, then once daily for 4 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
budesonide rectal foam
What this could lead to
If successful, this could provide a new treatment option for children with ulcerative colitis, helping them achieve remission without stronger medications.
What could go wrong
This is a phase 4 trial, but it's still early for this specific age group. The placebo group may also improve, and the foam may not work better than placebo. Side effects like irritation or infection are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.