ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225275

Enrollment

Registered

2020-07-14

Start date

2020-07-31

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

investigational material(s) Generic name etc : etrasimod INN of investigational material : - Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Inves

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed with ulcerative colitis (UC) >= 3 months prior to screening. Active UC confirmed by endoscopy.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ]	—

Secondary

Measure	Time frame
efficacy 1. Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ] 2. Proportion of participants With Mucosal Healing Assessed by Geboes Index Scores [ Time Frame: Week 12 ]	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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