Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

Arena Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Etrasimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02447302

APD334-003

2015-001942-28 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 156 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
• Evidence of colonic ulcerative colitis activity on endoscopy

Exclusion criteria

• Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
• Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
• Any prior exposure to natalizumab, efalizumab, or rituximab

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 3 patient groups, including a placebo group

Etrasimod Low Dose

Experimental group

Description:

Oral, low dose, daily for 12 Weeks

Treatment:

Drug: Etrasimod

Etrasimod High Dose

Experimental group

Description:

Oral, high dose, daily for 12 weeks

Treatment:

Drug: Etrasimod

Placebo

Placebo Comparator group

Description:

Oral, placebo, daily for 12 weeks.

Treatment:

Drug: Placebo