An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

Summary

The purpose of the study is to evaluate the efficacy and safety of LYC-30937-EC given orally once daily in subjects with active ulcerative colitis (UC) defined as a total Mayo score (TMS) of 4-11 inclusive, with an endoscopic score of ≥ 2 and a rectal bleeding score of ≥ 1 at screening.

Timeline

Start

2016-07

Primary completion

2018-05

Completion

2018-05

Outcome

Missed primary endpoint

registry analysis (superiority test); LYC-30937-EC 25 mg PO QD vs Placebo PO QD; p = 0.106; Risk Difference (RD) -8.1 NCT02762500 ↗

Drugs

Indications