Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.