Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis - GLADIATOR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003507-34-FR

Enrollment

162

Registered

2020-12-16

Start date

2021-02-02

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856

Interventions

Product Name: Etrasimod Product Code: APD334 Pharmaceutical Form: Tablet INN or Proposed INN: etrasimod L-arginine CAS Number: 1206123-97-8 Current Sponsor code: APD334 L-arginine Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosed with UC = 3 months prior to screening - Active UC confirmed by endoscopy - Moderately active UC defined as an MMS of 4 to 6 and an ES = 1 - Received a surveillance colonoscopy within 12 months before baseline Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 147 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: - Severe extensive colitis - Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease - Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis - Hospitalization for exacerbation of UC requiring intravenous (IV) steroids within 12 weeks of screening

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the efficacy of etrasimod on clinical remission in subjects with moderately active UC after 12 weeks of treatment.;Secondary Objective: to assess the efficacy of etrasimod on endoscopic improvement, histologic response, clinical response, and symptomatic remission, after 12 weeks of treatment. ;Primary end point(s): proportion of subjects achieving clinical remission (based on TMS) at Week 12;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: to assess the efficacy of etrasimod on clinical remission in subjects with moderately active UC after 12 weeks of treatment.;Secondary Objective: to assess the efficacy of etrasimod on endoscopic improvement, histologic response, clinical response, and symptomatic remission, after 12 weeks of treatment. ;Primary end point(s): proportion of subjects achieving clinical remission (based on TMS) at Week 12;Timepoint(s) of evaluation of this end point: Week 12

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of subjects with reduction from baseline in both endoscopic score (ES) and rectal bleeding OR in both ES and stool frequency at Week 12 • Proportion of subjects with endoscopic improvement at Week 12 • Proportion of subjects with histologic response at Week 12 • Proportion of subjects with a clinical response (based on TMS) at Week 12 • Proportion of subjects in symptomatic remission at Week 12;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Secondary end point(s): • Proportion of subjects with reduction from baseline in both endoscopic score (ES) and rectal bleeding OR in both ES and stool frequency at Week 12 • Proportion of subjects with endoscopic improvement at Week 12 • Proportion of subjects with histologic response at Week 12 • Proportion of subjects with a clinical response (based on TMS) at Week 12 • Proportion of subjects in symptomatic remission at Week 12;Timepoint(s) of evaluation of this end point: Week 12

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Countries

Australia, Belgium, Bulgaria, Canada, Czechia, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Moldova, Republic of, Netherlands, Poland, Portugal, Russian Federation, South Africa, Spain, United States

Contacts

Public ContactLaurence Hechmati-Debefve

Arena Pharmaceuticals, Inc.

lhechmati@arenapharm.com+4141552 2681

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026