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 UC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003507-34-CZ

Enrollment

225

Registered

2020-12-10

Start date

2021-01-28

Completion date

Unknown

Last updated

2024-07-29

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

PF-07915503-94 (L-arginine salt) Other descriptive name: AR401959 L-arginine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo:

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 = 2 and RB score = 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 214 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11

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 52 weeks of treatment.;Secondary Objective: to assess the efficacy of etrasimod on endoscopic improvement, histologic response, clinical response, and symptomatic remission, at timepoints up to 52 weeks of treatment. ;Primary end point(s): proportion of subjects achieving clinical remission (based on MMS) at Week 52;Timepoint(s) of evaluation of this end point: Week 52	—

Measure

Time frame

Main Objective: to assess the efficacy of etrasimod on clinical remission in subjects with moderately active UC after 52 weeks of treatment.;Secondary Objective: to assess the efficacy of etrasimod on endoscopic improvement, histologic response, clinical response, and symptomatic remission, at timepoints up to 52 weeks of treatment. ;Primary end point(s): proportion of subjects achieving clinical remission (based on MMS) at Week 52;Timepoint(s) of evaluation of this end point: Week 52

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of subjects achieving clinical remission at Week 12 • Proportion of subjects with endoscopic improvement at Week 52 • Proportion of subjects in symptomatic remission at Week 52 • Proportion of subjects achieving mucosal healing at Week 52 • Proportion of subjects achieving clinical remission at both Weeks 12 and 52 • Proportion of subjects achieving clinical remission at Week 52 and who had not been receiving corticosteroids for = 12 weeks immediately prior to Week 52;Timepoint(s) of evaluation of this end point: Week 52	—

Measure

Time frame

Secondary end point(s): • Proportion of subjects achieving clinical remission at Week 12 • Proportion of subjects with endoscopic improvement at Week 52 • Proportion of subjects in symptomatic remission at Week 52 • Proportion of subjects achieving mucosal healing at Week 52 • Proportion of subjects achieving clinical remission at both Weeks 12 and 52 • Proportion of subjects achieving clinical remission at Week 52 and who had not been receiving corticosteroids for = 12 weeks immediately prior to Week 52;Timepoint(s) of evaluation of this end point: Week 52

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Countries

Australia, Belarus, Belgium, Bulgaria, Czechia, Czech Republic, France, Georgia, Germany, Hungary, Israel, Italy, Korea, Republic of, Poland, Portugal, Russian Federation, 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