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Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis

NCT07650942 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-06-16

No results posted yet for this study

Summary

The purpose of this phase III, multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Hemay005 compared to placebo as induction and maintenance therapy in Chinese participants with moderately to severely active ulcerative colitis.

Conditions

  • Ulcerative Colitis (UC)

Interventions

DRUG

Hemay005 tablet

Participants receive treatment with Hemay005 tablet during the Induction Phase (week I-0\~I-12).

DRUG

Placebo

Participants receive treatment with placebo tablet during the Induction Phase (week I-0\~I-12).

DRUG

Hemay005 tablet

Participants receive treatment with Hemay005 tablet during the Maintenance Phase (week M-0\~M-40).

DRUG

Placebo

Participants receive treatment with placebo during the Maintenance Phase (week M-0\~M-40).

Sponsors & Collaborators

  • Ganzhou Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Minhu Chen, M.D · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-05-31
Completion
2029-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07650942 on ClinicalTrials.gov