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Not yet recruitingNCT05976802Updated Oct 6, 2026

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

A Phase 4 interventional study of High dose budesonide rectal foam and Low dose budesonide rectal foam in Ulcerative Colitis, sponsored by Bausch Health Americas, Inc.. Not yet recruiting. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Phase 4, Interventional, and Treatment

Updated Oct 6, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Ulcerative Colitis

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03

In context

Colitis, Ulcerative

1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Bausch Health Americas, Inc. is the lead sponsor of 213 studies on the registry; 7 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

First submitted after Bausch Health Americas, Inc. became part of Bausch Health Companies Inc..

Browse Bausch Health Americas, Inc. studies →All Bausch Health Companies Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    High dose budesonide rectal foam

    Drug: High dose budesonide rectal foam

  • Experimental
    Low dose budesonide rectal foam

    Drug: Low dose budesonide rectal foam

  • Placebo comparator
    Matching placebo rectal foam

    Drug: Matching placebo rectal foam

Interventions

  • DrugHigh dose budesonide rectal foam

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

  • DrugLow dose budesonide rectal foam

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

  • DrugMatching placebo rectal foam

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

06

What researchers measure

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.

    Time frame: Day 42

Secondary outcomes

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

    Scored from 0 to 3, with higher scores indicating more severe disease.

    Time frame: Day 42

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

    Scored from 0 to 3, with higher scores indicating more severe disease.

    Time frame: Day 42

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

    Scored from 0 to 3, with higher scores indicating more severe disease.

    Time frame: Day 42

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Jun 2027→Jun 2029
Oct 6, 2026
Primary completion
Jun 2029→Jun 2030
Oct 6, 2026
Study completion
Jan 2030→Jan 2031
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Start date Jun 2027→Jun 2029
    Primary completion Jun 2029→Jun 2030
    Study completion Jan 2030→Jan 2031
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05976802
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
Aug 4, 2023
Start date
Jun 2029 (estimated)
Primary completion
Jun 2030 (estimated)
Completion
Jan 2031 (estimated)
Last update
Oct 6, 2026

Study contacts

Varsha Bhatt
Contact
Varsha.Bhatt@bauschhealth.com
707-285-1528
Varsha Bhatt
study director · Bausch Health Americas, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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