NCT05976802View on ClinicalTrials.gov

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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2027

Primary Completion Date

June 30, 2029

Study Completion Date

January 31, 2030

Conditions
Ulcerative Colitis
Interventions
DRUG

High dose budesonide rectal foam

Twice a day for 2 weeks, then once a day for 4 weeks

DRUG

Low dose budesonide rectal foam

Twice a day for 2 weeks, then once a day for 4 weeks

DRUG

Matching placebo rectal foam

Twice a day for 2 weeks, then once a day for 4 weeks

All Listed Sponsors
lead

Bausch Health Americas, Inc.

INDUSTRY