Summary:
A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately Active Ulcerative Colitis
- Men or women 18 to 80 years of age, inclusive, at the time of consent
- Diagnosed with UC ≥ 3 months prior to screening.
- Demonstrated an inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies as defined below: Conventional therapy a. Oral 5-aminosalicylic acid (5-ASA) compounds b. Corticosteroids c. Thiopurines Biologic therapy or JAK inhibitor therapy a. Antitumor necrosis factor alpha (TNFα) antibodies (eg, infliximab, adalimumab, golimumab, or biosimilars) b. Anti-integrin antibodies (eg, vedolizumab) c. Interleukin 12/23 antibodies (eg, ustekinumab) d. JAK inhibitors (eg, tofacitinib)