Ulcerative ColitisPhase 4NCT05976802
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 study testing High dose budesonide rectal foam and Low dose budesonide rectal foam in people with Ulcerative Colitis, run by Bausch Health Americas, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- High dose budesonide rectal foam and Low dose budesonide rectal foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2029to Jan 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Current or prior diagnosis of Crohn's disease or indeterminate colitis.
- Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and/or ascending colon and cecum;
- Severe UC, defined as an mMCS > 8.
- Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days of Screening).
- 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.
- Evidence or history of toxic megacolon or bowel resection.
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
- Conditions
- Ulcerative Colitis
- Being tested
- High dose budesonide rectal foam, Low dose budesonide rectal foam, Matching placebo rectal foam
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose budesonide rectal foamDrug
Twice a day for 2 weeks, then once a day for 4 weeks
Low dose budesonide rectal foamDrug
Twice a day for 2 weeks, then once a day for 4 weeks
Matching placebo rectal foamDrug
Twice a day for 2 weeks, then once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| High dose budesonide rectal foam | Experimental | Not described Receives: Drug: High dose budesonide rectal foam |
| Low dose budesonide rectal foam | Experimental | Not described Receives: Drug: Low dose budesonide rectal foam |
| Matching placebo rectal foam | Placebo comparator | Not described Receives: Drug: Matching placebo rectal foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 42
Secondary outcomes (3)
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.
Measured: Day 42
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.
Measured: Day 42
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.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study startJun 2029 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Varsha Bhatt, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976802
- Sponsor's protocol ID
- BFUC4991
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- BFUC4991
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2029 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose budesonide rectal foam | Experimental | Drug: High dose budesonide rectal foam |
| Low dose budesonide rectal foam | Experimental | Drug: Low dose budesonide rectal foam |
| Matching placebo rectal foam | Placebo comparator | Drug: Matching placebo rectal foam |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Current or prior diagnosis of Crohn's disease or indeterminate colitis.
- Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and/or ascending colon and cecum;
- Severe UC, defined as an mMCS > 8.
- Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days of Screening).
- Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose budesonide rectal foamTwice a day for 2 weeks, then once a day for 4 weeks | Drug | High dose budesonide rectal foam |
| Low dose budesonide rectal foamTwice a day for 2 weeks, then once a day for 4 weeks | Drug | Low dose budesonide rectal foam |
| Matching placebo rectal foamTwice a day for 2 weeks, then once a day for 4 weeks | Drug | Matching placebo rectal foam |
Primary outcome
Proportion of participants with clinical remission
Time frame: Day 42
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.
3 secondary outcomes
Proportion of participants who achieve a rectal bleeding subscale score of 0 at the end of six weeks of treatment
Time frame: Day 42
Proportion of participants who achieve a stool frequency subscale score of 0 at the end of six weeks of treatment.
Time frame: Day 42
Proportion of subjects who achieve an endoscopy subscale score of 0 or 1 at the end of six weeks of treatment.
Time frame: Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Ulcerative Colitis
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Varsha Bhatt study director
Bausch Health Americas, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High dose budesonide rectal foam and Low dose budesonide rectal foam in people with Ulcerative Colitis, run by Bausch Health Americas, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Varsha Bhatt (707-285-1528, Varsha.Bhatt@bauschhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with clinical remission (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.