Purpose

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

Condition

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
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 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

Recruiting Locations

More Details

NCT ID
NCT03945188
Status
Recruiting
Sponsor
Arena Pharmaceuticals

Study Contact

Arena CT.gov Administrator
855-218-9153
ct.gov@arenapharm.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.