Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis

Summary

This study adopts a multicenter, randomized, double-blind, low-medium-high dose group and placebo parallel controlled clinical study design. After screening, patients with active ulcerative colitis who meet the inclusion criteria and do not meet the exclusion criteria will be randomized by 1:1:1:1 to Hemay007 400 mg BID group, 800 mg QD group, 600 mg BID group or placebo group, with proposed 72 cases in each group. After 12 weeks of double-blind inductive treatment period, the patients will enter the Hemay007 open treatment period of 12 weeks when Hemay007 600 mg BID will be used as the medication regimen. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.

Timeline

Start

2019-08-13

Primary completion

2022-08-12

Completion

2022-08-12

Outcome

Outcome not reported

Stopped (Enrollment): “Due to the difficulty to recruit enough patients, the study was terminated.”

Drugs

Indications