# 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

> **NCT05976802** · PHASE4 · NOT_YET_RECRUITING · sponsor: **Bausch Health Americas, Inc.** · enrollment: 100 (estimated)

## Conditions studied

- Ulcerative Colitis

## Interventions

- **DRUG:** High dose budesonide rectal foam
- **DRUG:** Low dose budesonide rectal foam
- **DRUG:** Matching placebo rectal foam

## Key facts

- **NCT ID:** NCT05976802
- **Lead sponsor:** Bausch Health Americas, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2027-06
- **Primary completion:** 2029-06
- **Final completion:** 2030-01
- **Target enrollment:** 100 (ESTIMATED)
- **Last updated:** 2025-09-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05976802

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05976802, "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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT05976802. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*