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Not yet recruitingNCT05976802Updated Sep 18, 2025

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 2025-09-18.

Sponsored by Bausch Health Americas, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
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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).

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Conditions studied

  • Ulcerative Colitis

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Who can participate

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

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

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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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

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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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05976802
Lead sponsor
Bausch Health Americas, Inc.
Responsible party
Sponsor
First posted
Aug 4, 2023
Start date
Jun 2027 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Jan 2030 (estimated)
Last update
Sep 18, 2025

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 ↗

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