Ulcerative Colitis
Extended-release budesonide in children with mild-to-moderate ulcerative colitis
This study compares two doses of extended-release budesonide with placebo while evaluating remission, safety, and drug processing in children ages 5–17 with active mild-to-moderate ulcerative colitis.
Registry title: Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
4 recruiting U.S. sites ↓Study at a glance
- Age
- 5 Years–17 Years
- Treatment
- Low Dose Budesonide or High Dose Budesonide
- Design
- Randomized · Double
- Central study contact
- Sandra Narain9082428287sandra.narain@bauschhealth.com
- Sponsor
- Bausch Health Americas, Inc.
Research question
Among children with active mild-to-moderate ulcerative colitis, how do two doses of extended-release budesonide compare with placebo for inducing remission, safety, and pharmacokinetics, meaning how the drug moves through the body?
Participant snapshot
Who the study is looking for
- The study is looking for children ages 5–17 who weigh more than 13.6 kilograms at baseline.
- The study is looking for children with an established ulcerative colitis diagnosis supported by clinical history, endoscopy findings, and biopsy results.
- The ulcerative colitis must be active and mild or moderate, with the specified total and component Mayo scores.
- The registry lists recruiting sites in California, Indiana, New York, and North Carolina.
Participation overview
What participation may involve
Participants are randomly assigned to once-daily low-dose budesonide, high-dose budesonide, or matching placebo. Eligible participants using stable oral or rectal 5-aminosalicylate may continue it unchanged. What participation may involve: - Take the assigned budesonide dose or matching placebo once daily. - Report stool frequency and rectal bleeding for Mayo score assessments. - Undergo an endoscopy assessment used in the Mayo score at Day 56. - Participants already using an eligible stable oral or rectal 5-aminosalicylate may continue the same formulation and dose during the study.
Study interventions
What participants may receive or do
- Low Dose Budesonide: Participants assigned to this group take extended-release budesonide once daily: 3 milligrams for ages 5 through 11 years 11 months, or 6 milligrams for ages 12–17.
- High Dose Budesonide: Participants assigned to this group take extended-release budesonide once daily: 6 milligrams for ages 5 through 11 years 11 months, or 9 milligrams for ages 12–17.
- Placebo: Participants assigned to this comparison group take a matching placebo once daily.
Study design
How the comparison works
This Phase 4 study assigns participants to parallel groups receiving low-dose budesonide, high-dose budesonide, or placebo and compares their outcomes. Assignment to the three study groups is randomized. The study is double-blind: participants and investigators are masked to treatment assignment. The placebo group serves as the comparison for the two budesonide dose groups. The placebo is described as matching and taken once daily, but the registry does not report the chance of assignment to it.
Reported activities
Procedures and tests
- The Mayo score combines participant-reported stool frequency and rectal bleeding, endoscopy findings, and a physician rating of disease activity.
- An endoscopy score is assessed at Day 56 as part of the primary and secondary outcomes.
- Screening may involve confirming the ulcerative colitis diagnosis through clinical history, characteristic endoscopy findings, and biopsy histopathology results.
- Screening includes microbiologic testing to assess for infectious colitis.
- The study evaluates budesonide pharmacokinetics, but the registry does not describe the sampling procedures or schedule.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- An established ulcerative colitis diagnosis must be supported by clinical history, characteristic endoscopy findings, and biopsy histopathology.
- Participants must be ages 5–17 at screening and weigh more than 13.6 kilograms at baseline.
- Ulcerative colitis must be active and mild or moderate, with a total Mayo score of 4–10 and scores of at least 1 for rectal bleeding, stool frequency, and endoscopy.
- If using oral or rectal 5-aminosalicylate, its dose and formulation must have been unchanged for at least six weeks before randomization and remain unchanged during the study.
Possible reasons someone may not be able to join
- A current or prior diagnosis of Crohn's disease or indeterminate colitis excludes participation.
- Disease limited to the first 15 centimeters or less from the anal verge is excluded.
- Severe ulcerative colitis, defined as a total Mayo score above 10, is excluded.
- Participants must be in an active flare; a total Mayo score below 4, or a score of 4–10 with a zero component score for rectal bleeding, stool frequency, or endoscopy, is excluded.
- Infectious colitis found by screening tests, or infectious colitis within 30 days before screening, is excluded.
- Prior gastrointestinal surgery is excluded except appendectomy or hernia surgery; cholecystectomy is allowed if it occurred more than one year before screening.
- Evidence or a history of toxic megacolon or bowel resection excludes participation.
Important unknowns
What the record does not make clear
- The registry identifies randomization as Visit 2 but does not provide the full number, timing, or format of study visits.
- Outcomes are assessed at Day 56, but the record does not state each participant's total time in the study.
- Three randomized groups are listed, but their assignment ratios and the probability of receiving placebo are not reported.
- Stable oral or rectal 5-aminosalicylate may continue, but the record does not explain how other ulcerative colitis treatments are handled.
- The record does not provide washout requirements for medicines other than the stable 5-aminosalicylate treatment it permits.
- The registry does not describe treatment options if ulcerative colitis worsens during the study.
- An endoscopy score is assessed at Day 56, but the record does not clarify whether additional endoscopies, sedation, or biopsies are required.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- Compensation or reimbursement is not described.
- The record does not describe transportation, lodging, or other travel support.
- The registry does not state whether any visits or assessments can be completed remotely.
- The record does not describe access to budesonide after study participation ends.
- Four sites are listed as recruiting, but the recruitment status was last verified in September 2025 and current openings must be confirmed.
Before contacting the site
Questions for the study team
- How many visits are required, how long does participation last, and which visits must occur in person?
- What is the chance of assignment to placebo, and how long is the assigned treatment taken?
- Which current medicines can continue, which require a washout, and what rescue treatment is available if symptoms worsen?
- How many endoscopies, blood draws, biopsies, or pharmacokinetic samples are required, and is sedation used?
- Which study-related costs are covered, and are compensation, travel reimbursement, or caregiver support available?
- Is the nearest listed site currently enrolling, and can any assessments be completed remotely?
Before changing care
Questions for your gastroenterologist
- How stable is my child's ulcerative colitis now, and how does the current Mayo score compare with the study's required activity range?
- Would any current treatment need to change, and what clinical concerns would those changes create?
- What approved treatment alternatives should we compare with this study for active mild-to-moderate ulcerative colitis?
- How should you and the research team coordinate symptom monitoring, endoscopy results, medication decisions, and care if the disease worsens?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.
Study design and administration
- Organization
- Bausch Health Americas, Inc.
- Organization class
- Industry
- Organization study ID
- BUUC4991
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Child
Study arms
Experimental
Low Dose Budesonide
Interventions: Drug: Low Dose Budesonide
Experimental
High Dose Budesonide
Interventions: Drug: High Dose Budesonide
Placebo Comparator
Placebo
Interventions: Drug: Placebo
Interventions
Drug
Low Dose Budesonide
3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.
Drug
High Dose Budesonide
6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.
Drug
Placebo
Matching placebo once daily.
Eligibility
5 Years–17 Years
All
Not accepted
Inclusion criteria (7)
- Established diagnosis of UC is based on:Registry-derived · unreviewed
- Clinical historyRegistry-derived · unreviewed
- Characteristic endoscopic findingsRegistry-derived · unreviewed
- Histopathology results from biopsiesRegistry-derived · unreviewed
- Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.Registry-derived · unreviewed
- Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1.Registry-derived · unreviewed
- If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study.Registry-derived · unreviewed
Exclusion criteria (7)
- Current or prior diagnosis of Crohn's disease or indeterminate colitis.Registry-derived · unreviewed
- Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.Registry-derived · unreviewed
- Severe UC, defined as total Mayo score \>10.Registry-derived · unreviewed
- Not currently in an active phase or flare, defined as a total Mayo score \<4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy.Registry-derived · unreviewed
- Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).Registry-derived · unreviewed
- Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).Registry-derived · unreviewed
- Evidence or history of toxic megacolon or bowel resection.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy.
Time frame: 56 days
The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.
Secondary outcome
Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56.
Time frame: 56 days
Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.
Secondary outcome
Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56.
Time frame: 56 days
Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.
Secondary outcome
Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56.
Time frame: 56 days
Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56. The Mayo score is a composite index score based on 4 components: stool frequency (subject reported), rectal bleeding (subject reported), findings of endoscopy, and the physician's rating of disease activity. Each component is scored from 0 to 3, with total scores range from 0 to 12 with higher scores indicating more severe disease.
Recruiting locations in the United States
Bausch Health Site 008
RecruitingGarden Grove, California, 92845, United States
Bausch Health Site 003
RecruitingIndianapolis, Indiana, 46202, United States
Bausch Health Site 006
RecruitingThe Bronx, New York, 10467, United States
Bausch Health Site 010
RecruitingGreenville, North Carolina, 27834, United States
Central study contacts
Registry dates
- First posted
- Mar 19, 2020
- Primary completion
- Dec 2026
- Overall completion
- Jun 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.