Ulcerative Colitis
Conditions
Brief 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).
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
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with clinical remission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who achieve a rectal bleeding subscale score of 0 at the end of six weeks of treatment | Day 42 | Scored from 0 to 3, with higher scores indicating more severe disease. |
| Proportion of participants who achieve a stool frequency subscale score of 0 at the end of six weeks of treatment. | Day 42 | Scored from 0 to 3, with higher scores indicating more severe disease. |
| Proportion of subjects who achieve an endoscopy subscale score of 0 or 1 at the end of six weeks of treatment. | Day 42 | Scored from 0 to 3, with higher scores indicating more severe disease. |
Contacts
Primary ContactVarsha Bhatt
Outcome results
None listed