Summary:
ELEVATE UC is a worldwide clinical study of an investigational pill, Etrasimod, taken once a day opposed to the currently available infused or injected treatments. For some people needle sticks can be uncomfortable. Past research of ELEVATE suggest that this medication may reduce inflammation in the colon, improve UC symptoms and treatment. You could be enrolled into a 52 weeks ( APD334-301) or a 12 weeks (ADP334-02) studies to access the efficacy of Etrasimod in patients with moderately to severely active Ulcerative Colitis. Patients whose disease is stable or improving will continue with their double-blind treatment and move into the 40-Week treatment period. At the end of the Induction Treatment Period, subjects will undergo the Week 12 study assessments. All subjects will then have the option to enter an open-label, OLE study, APD334-303 (up to 260 weeks/5years) following completion of Week 12 study procedures and providing they meet all inclusion criteria.
Qualified Participants Must:
• Eligible to participate if you are 16 to 80 years old
•
Have been diagnosed with UC, and did not respond to or are no longer responding to or do not tolerate another UC therapy
*There are other eligibility criteria. Please contact the study team to find out more.
Qualified Participants May Receive:
Get access to the oral, once-daily investigational medication at no cost. Free regular monitoring (office visits, labs, eye exams, pulmonary function tests, physicals, colonoscopies, etc.) by a GI specialists. For the APD334-301 study component eligible subjects will be randomized (2:1 ratio) to receive either etrasimod (2 mg once daily) or matching placebo (once daily) in a double-blind fashion for up to 52 weeks (12-Week Treatment Period + 40-Week Treatment Period) similar to the ADP334-302 in which the eligible subjects will also be randomized (2:1 ratio) to receive either etrasimod (2 mg once daily) or matching placebo (once daily) in a double-blind fashion for 12 weeks. At the completion all subjects will then have the option to enter an open-label (OLE) study, APD334-303. All subjects will receive estrasimod 2mg for up to 260 weeks (5 years) or until marketing authorization is obtained in their country.