Clinical Trial

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2022-08-01; most recent amendment 2026-04-01.
Status change: Recruiting → Active, Not Recruiting 2025-04-02
Status change: Not Yet Recruiting → Recruiting 2023-04-06
Trial Details
NCT Number NCT05486104
Lead Sponsor Ganzhou Hemay Pharmaceutical Co., Ltd
Conditions Moderate to Severe Ulcerative Colitis
Enrollment 92 participants
Start Date 2022-11-08
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-03