drugset / Trial / NCT05486104

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

NCT05486104

Phase 2 Active not recruiting 92 enrolled Ganzhou Hemay Pharmaceutical Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, randomized, double-blind study. There are three dosage groups: Hemay005 45 mg BID group, 60 mg BID group or placebo group, with 36 patients in each dosage group. All patients will enter a 12-week double-blind treatment period. All subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.

Timeline

Start
2022-11-08
Primary completion
2026-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MUFEMILAST Small molecule 45 mg Oral
Subject MUFEMILAST Small molecule 60 mg Oral

Indications