A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II
study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe
active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time
needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which
participants who complete the first 12 weeks treatment phase, will have the option to enter a
blinded active arms 12-week extension phase. Early withdrawn subjects during the first
treatment phase cannot enter the extension phase. The total duration of the study
participation, including extension and follow-up, will be approximately 26 weeks.
With the wealth of scientific evidence on JAK/STAT involvement in IBD, the data from similar
class of new drugs and the current data on SHR0302 (JAK1 inhibitor), support the rationale to
proceed with phase II studies to evaluate the efficacy and safety of SHR0302 in patients with
moderate to severe active CD.