A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
Status:
Completed
Trial end date:
2021-02-03
Target enrollment:
Participant gender:
Summary
The proposed study is a randomized, double-blind,placebo-controlled, multi-center phase II
study to investigatethe safety and efficacy of SHR0302 in patients with moderate to severe
activeulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 andtime
needed in inducing clinical response in active ulcerative colitispatients.
This is an 8+8 weeksstudy, in which participants who complete the first 8 weeks treatment
phase, will have the option to enter a blinded activearms 8-week extension phase. Early
withdrawn subjects during the first treatment phasecannot enter the extension phase. The
total duration of the study participation, including extension and follow-up, will be
approximately 18weeks.
SHR0302 is a JAK1 inhibitor, capable of blocking JAK-STATs pathway and control inflammation.
Therefore it has the potential to be a treatment for UC.