Ongoing Clinical Trials
The US Food and Drug Administration (FDA), Health Canada, and Ireland’s Health Products Regulatory Authority (HPRA) have each given clearance to proceed with Sublimity’s Phase 2b clinical trial for ST-0529: 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 18 countries.
Patients with a previous history of having failed a single biologic will be eligible for enrollment. Data generated from CYC-202 will also support the design of a Phase 3 registration trial.