A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

  • STATUS
    Not Recruiting
  • participants needed
    152
  • sponsor
    Reistone Biopharma Company Limited
Updated on 16 September 2021
endoscopy

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 Early withdrawn subjects during the first treatment phasecannot enter the extension phase.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.

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment placebos, SHR0302
Clinical Study IdentifierNCT03675477
SponsorReistone Biopharma Company Limited
Last Modified on16 September 2021

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