Etrasimod Dose-Ranging Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

JRCT ID: jRCT2071210052

Registered date:19/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 16/10/2021
• Target sample size: 96
• Study type: Interventional
• Intervention(s): Eligible subjects will be randomized (1:1:1ratio) to receive either etrasimod (dose A), etrasimod (dose B), or matching placebo (once daily) in a double-blind fashion for 12 weeks

Outcome(s)

• Primary Outcome: The proportion of subjects achieving clinical remission at Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- Japanese ancestry
- Diagnosed with ulcerative colitis (UC) => 3 months prior to screening
- Having active UC confirmed by endoscopy
- Moderately to severely active UC

Exclude criteria

- Severe extensive colitis
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Related Information

• Primary Sponsor: Tanabe Masakazu