Evaluating Budesonide Tablets for Children with Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

This study is testing if budesonide tablets can help children aged 5 to 17 with mild to moderate ulcerative colitis feel better and achieve remission.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: Bausch Health Americas, Inc. (industry)
• Locations: 4 sites (Garden Grove, California and 3 other locations)
• Trial ID: NCT04314375 on ClinicalTrials.gov

What this trial studies

This study is a randomized, double-blind, placebo-controlled trial aimed at assessing the safety, efficacy, and pharmacokinetics of budesonide extended-release tablets in children aged 5 to 17 years who have active, mild to moderate ulcerative colitis. Participants will be allowed to continue their current treatment with oral or rectal 5-aminosalicylate products. The study will compare different doses of budesonide against a placebo to determine the best approach for inducing remission in these pediatric patients.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 5 to 17 years with a confirmed diagnosis of active, mild to moderate ulcerative colitis.

Not a fit: Patients with severe ulcerative colitis or those with a diagnosis of Crohn's disease or indeterminate colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for children suffering from mild to moderate ulcerative colitis.

How similar studies have performed: Other studies have shown promise in using budesonide for ulcerative colitis, but this specific approach in pediatric patients is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Established diagnosis of UC is based on:

  * Clinical history
  * Characteristic endoscopic findings
  * Histopathology results from biopsies
* Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.
* 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.
* 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.

Exclusion Criteria:

1. Current or prior diagnosis of Crohn's disease or indeterminate colitis.
2. Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.
3. Severe UC, defined as total Mayo score \>10.
4. 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.
5. Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).
6. 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.
7. Evidence or history of toxic megacolon or bowel resection.

Where this trial is running

Garden Grove, California and 3 other locations

• Bausch Health Site 008 — Garden Grove, California, United States (RECRUITING)
• Bausch Health Site 003 — Indianapolis, Indiana, United States (RECRUITING)
• Bausch Health Site 006 — The Bronx, New York, United States (RECRUITING)
• Bausch Health Site 010 — Greenville, North Carolina, United States (RECRUITING)

Study contacts

• Study coordinator: Sandra Narain

Conditions: Ulcerative Colitis