Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Purpose

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

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Etrasimod 2 mg
  • Drug: Etrasimod
    Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
    Other names:
    • APD334
Placebo Comparator
Placebo
  • Drug: Placebo
    Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

More Details

Status
Completed
Sponsor
Arena Pharmaceuticals

Study Contact