Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC 52)

Arena Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Etrasimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03945188

APD334-301

2018-003985-15 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Enrollment: 433 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
2. Active UC confirmed by endoscopy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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433 participants in 2 patient groups, including a placebo group

Etrasimod 2 mg

Experimental group

Treatment:

Drug: Etrasimod

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo