Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

Purpose

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).

Condition

  • Ulcerative Colitis

Eligibility

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

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

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Etrasimod 2 mg
  • Drug: Etrasimod
    Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period
    Other names:
    • APD334
Placebo Comparator
Placebo
  • Drug: Placebo
    Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period

More Details

Status
Completed
Sponsor
Arena Pharmaceuticals

Study Contact