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Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

NCT05486104 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Moderate to Severe Ulcerative Colitis

Interventions

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.

Sponsors & Collaborators

  • Ganzhou Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Shutian Zhang, MD · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05486104 on ClinicalTrials.gov