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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Etrasimod 2 mg |
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Completed
- Sponsor
- Arena Pharmaceuticals