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
- Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening 2. Active UC confirmed by endoscopy
Exclusion Criteria
- 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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Etrasimod 2 mg |
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Completed
- Sponsor
- Arena Pharmaceuticals