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

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT05976802
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • High dose budesonide rectal foam — DRUG
    Twice a day for 2 weeks, then once a day for 4 weeks
  • Low dose budesonide rectal foam — DRUG
    Twice a day for 2 weeks, then once a day for 4 weeks
  • Matching placebo rectal foam — DRUG
    Twice a day for 2 weeks, then once a day for 4 weeks

Study Details

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).

Key Dates

First listed
Aug 4, 2023
Start date
Jun 30, 2027
Status verified
Sep 2025
Primary completion
Jun 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High dose budesonide rectal foam
  • Experimental: Low dose budesonide rectal foam
  • Placebo Comparator: Matching placebo rectal foam

Primary Outcome Measure

Proportion of participants with clinical remission [ Time Frame: Day 42 ]

Central Contacts

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