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

• Status: Completed
• Trial end date: 2021-02-03
• Target enrollment: 0
• Participant gender: All

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 Early withdrawn subjects during the first treatment phasecannot enter the extension phase.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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reistone Biopharma Company Limited

Criteria

Inclusion Criteria:

• Male and Female subject age ≥ 18 and ≤75 years of age at randomization.

• Active ulcerative colitis with a 9-point modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (The duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization).

• Subject should have at least three-month history of Ulcerative Colitis diagnosis at randomization.

Exclusion Criteria:

• Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.

• Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less).

• Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).