Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 510
Healthy volunteers: no

Brief summary:
This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

Detailed description:
Eligible participants will be randomized to 1 of the following 2 treatment arms:

1. Budesonide MMX 9 mg (1 tablet)
2. Placebo (tablet indistinguishable from budesonide MMX 9 mg tablet)

The assigned study drug will be taken as a single oral tablet each morning after breakfast. In addition to the study drug, all participants will continue their existing background oral 5-ASA regimen during the treatment period.

Arms:
arm 1: Participants will receive 1 oral tablet of budesonide MMX 9 mg for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician. arm 2: Participants will receive 1 oral tablet of matching budesonide MMX placebo for 56 days. Additionally, participants will continue to receive the same dose of their existing oral 5-ASA medication from their treating physician.

Interventions: intervention 1: Budesonide MMX® intervention 2: Placebo intervention 3: 5-ASA
Intervention descriptions: intervention 1: Oral tablet taken daily in the morning after breakfast. intervention 2: Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast. intervention 3: Acceptable oral 5-ASA medications to be received during the study include:

* Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)
* Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g
* Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g
* Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g

Protocol document: