The AURORA Study is Now Enrolling!
The AURORA Study (CYC-202)
The US Food and Drug Administration (FDA), Health Canada, Ireland’s Health Products Regulatory Authority (HPRA) and more than ten additional European regulatory agencies have each given clearance to proceed with Sublimity’s Phase 2b clinical trial for ST-0529: The AURORA Study (CYC-202). A range of twice-daily ST-0529 doses will be compared with placebo in patients presenting with moderate to severely active ulcerative colitis who are failing to demonstrate an adequate response to one or more of 5-ASA, steroid, or immunosuppressive therapies at screening. The study will involve approximately 280 patients in 17 countries.
Patients with a previous history of having failed a single biologic will be eligible for enrollment. Data generated from the AURORA Study will also support the design of a Phase 3 registration trial.