A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Everstar Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Moderately to Severely Active Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Etrasimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT04176588

ES101002

Details and patient eligibility

About

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

Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3

Enrollment: 341 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A documented of diagnosis with UC at least 3 months prior to screening.
2. Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved.

Exclusion criteria

1. Have severe extensive colitis
2. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
3. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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341 participants in 3 patient groups, including a placebo group

Experimental: Etrasimod 2mg

Experimental group

Description:

2mg/tablet, administratered orally, once daily

Treatment:

Drug: Etrasimod

Placebo Comparator: Placebo

Placebo Comparator group

Description:

matching tablet, administratered orally, once daily

Treatment:

Drug: Placebo

Etrasimod 2mg (optional open-label extension period)

Experimental group

Description:

2mg/tablet, administratered orally, once daily

Treatment:

Drug: Etrasimod