NCT05486104

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Low-High Dosing Regimens of Hemay005 in Patients With Moderate to Severe Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study adopts a multicenter, randomized, double-blind, low--high dose groups 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 to Hemay005 45 mg BID group, 60 mg BID group or placebo group, with proposed 36 patients in each group. All patients will enter a 12-week double-blind inductive treatment period. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.

Conditions

• Moderate to Severe Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Hemay005 tablets	Hemay005 tablets (15mg/tablet）will be orally administered twice daily.
DRUG	Hemay005 placebo tablets	Hemay005 placebo tablets will be orally administered twice daily.

Timeline

• Start date: 2022-11-08
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2022-08-03
• Last updated: 2026-04-03

Locations

18 sites across 1 country: China