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

Arena Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Etrasimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT03996369

APD334-302

2018-003986-33 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

Enrollment: 354 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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354 participants in 2 patient groups, including a placebo group

Etrasimod 2 mg

Experimental group

Treatment:

Drug: Etrasimod

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo