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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2071210052
Enrollment
96
Registered
2021-08-19
Start date
2021-10-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

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

Sponsors

Tanabe Masakazu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
The proportion of subjects achieving clinical remission at Week 12

Contacts

Public ContactjRCT Call Center IQVIA Services Japan K.K.

IQVIA Services Japan K.K.

JP_Arena_ELEVATE_UC@iqvia.com+81-120-229-053

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026