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

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Re-randomized Study To Assess the Efficacy and Safety With Hemay005 Tablets in Chinese Patients With Moderately to Severely Active Ulcerative Colitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: Hemay005 tablet; Drug: Hemay005 tablet; Drug: Placebo; Drug: Placebo

Detailed Description

This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety of Hemay005 in induction and maintenance therapy in Chinese patients with moderately or severely active ulcerative colitis. The study consists of two independent phases: an 12-week Induction Phase (might including an 12-week Extended Induction phase, depending on the participant status by the end of the induction treatment) and a 40-week Maintenance Phase. Screening period will be up to 5 Weeks.

In the Induction Phase, participants will be randomized 2:1 to receive either Hemay005 (twice daily) or placebo for 12 weeks. The randomization will be stratified by: exposed to advanced therapy (yes/no); disease severity (modified Mayo score of 5-6 or 7-9) and baseline corticosteroid use (yes/no). Participants who have not show clinical response (either receive Hemay005 or placebo) by week 12 will undergo an extended 12-week induction treatment with Hemay005.

After completing the Induction Phase (or the Extended Induction Phase), participants with response are eligible to go to the Maintenance Phase. Participants with a response to Hemay005 by week 12 of the Induction Phase and those with a response by the end of the Extended Induction Phase) will be randomized 1:1 to receive either Hemay005 (twice daily) or placebo for 40 weeks. Randomization will be stratified by corticosteroid use at the start date of Maintenance Phase (yes/no) and clinical remission status by the end of Induction Phase (yes/no). Participants who are assigned to placebo during the Induction Phase and have demonstrated a clinical response will continue to receive blinded placebo during the Maintenance Phase. Participants who have not showed a clinical response by week 12 of the Induction Phase but have a response to Hemay005 by the end of the Extended Induction Phase will continue to receive blinded Hemay005 during the Maintenance Phase.

During the Maintenance Phase, participants who are demonstrated loss of response will be eligible to go to the open-label treatment phase and treated with Hemay005. The total duration of open-label treatment phase will not exceed 40 weeks since the participant enrolled into the Maintenance Phase.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Han Hai; Phone Number: 86-22-24929530; Email: haihan@hemay.com.cn

Study Locations

• China
  • Guangzhou, China
    • The First Affiliated Hospital,Sun Yat-Sen University
    • Principal Investigator: Baili Chen
    • Contact: Minhu Chen, M.D; Phone Number: 86-020-87755766; Email: chenminhu@vip.163.com
  • Guangzhou, China
    • The Sixth Affiliated Hospital,Sun Yat-Sen University
    • Contact: Xiang Gao, M.D; Phone Number: 86-020-38254000
    • Principal Investigator: Xiang Gao, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men or women 18 to 80 years of age, inclusive, at the time of consent.
2. Voluntarily to give written informed consent.
3. Diagnosed with UC established at least 3 months prior to screen visit. The diagnosis must be confirmed by clinical and endoscopic evidence, corroborated by a histopathology report.
4. Active UC confirmed by endoscopy, classified as Montreal E2 or E3.
5. Moderately to severely active UC, defined as mMS of 5 to 9 points, including a MES of at least 2 (confirmed through centrally read endoscopy) and a SFS of at least 1 and a RBS of at least 1. The endoscopy should be performed within 14 days prior to randomization.

6. Demonstrated inadequate response, loss of response and/or intolerance to at least one of the following UC therapies:

   A) Conventional therapies, including oral 5-aminosalicylic acid (5-ASA) compounds, corticosteroids, immunoregulatory agents.

   B) Advanced therapies: biologics (including but not limit to antitumor necrosis factor alpha (TNFα) antibodies, anti-integrin antibodies, anti-interleukin 12/23 antibodies) and small molecule therapies(including but not limit to JAK inhibitors, S1P receptor modulators) Note: The medication used to qualify the subject for entry into this category must be approved for the treatment of UC in the country of use and the subject must have received an adequate course of therapy based on local guidelines for that therapy.

7. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception and agreement to refrain from egg donation or undergo fertility treatment during the treatment period and for 30 days after the final dose of Hemay005. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 30 days after the final dose of Hemay005.

Exclusion Criteria:

1. Current diagnosis of CD, abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.

2. Severe UC as evidenced by any of the following:

   A) Hospitalization for the treatment of UC ≤ 2 weeks prior to screening or, in the physician's judgement, is likely to require hospitalization for medical care or surgical intervention of any kind for UC during the study.

   B）Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months) of toxic megacolon, or bowel perforation.

   C）Prior history of subtotal, or total colectomy.

3. Past or current evidence of any gastrointestinal malignancy, either prior to or at the time of screening. History of malignancy within 5 years prior to screening visit, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer.
4. Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.
5. Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, ), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise patient safety, interfere with the potential participant's provision of informed consent, or compliance with trial procedures.
6. Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV).
7. Evidence of active tuberculosis (TB).
8. Any condition that would preclude endoscopic evaluation.
9. Either received protocol-specified prohibited medicines prior to baseline endoscopy and/ or randomization, or have not be washed out sufficiently due to the protocol before baseline endoscopy and/ or randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction Treatment Arm; 60mg, administratered orally, twice daily	Drug: Hemay005 tablet; Participants receive treatment with Hemay005 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).
Placebo Comparator: Induction Comparator Arm; matching tablet, administratered orally, twice daily	Drug: Placebo; Participants receive treatment with placebo tablet during the Induction Phase (week I-0~I-12).; Drug: Placebo; Participants receive treatment with placebo during the Maintenance Phase (week M-0~M-40).
Experimental: Maintenance Treatment Arm; 60mg, administratered orally, twice daily	Drug: Hemay005 tablet; Participants receive treatment with Hemay005 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).
Placebo Comparator: Maintenance Comparator Arm; matching tablet, administratered orally, twice daily	Drug: Placebo; Participants receive treatment with placebo tablet during the Induction Phase (week I-0~I-12).; Drug: Placebo; Participants receive treatment with placebo during the Maintenance Phase (week M-0~M-40).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction Phase: Percentage of Participants With Clinical Remission at Week 12.	Clinical remission is based on the Modified Mayo Score (mMS). The Modified Mayo Score (mMS) consists of Rectal Bleeding Subscore (RBS), Stool Frequency Subscore (SFS) and Mayo Endoscopic Subscore (MES). Each subscore ranges from 0 to 3 and a total mMS ranging from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined as a SFS of 0 or 1 with a decrease of at least 1 from baseline , and a RBS of 0, and a MES of 0 or 1 without friability.	Induction Phase Week 12
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 40.	Clinical remission is defined as a SFS of 0 or 1 with a decrease of at least 1 from baseline , and a RBS of 0, and a MES of 0 or 1 without friability.	Maintenance Phase: Week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction Phase: Percentage of Participants With Endoscopic Improvement at Week 12.	Endoscopic Improvement is based on the Mayo Endoscopic Subscore (MES). The MES ranges from 0 to 3, with higher scores indicating more severe disease. Endoscopic Improvement is defined as MES of 0 or 1(without friability).	Induction Phase: At Week 12
Induction Phase: Percentage of Participants With Completely Symptomatic Remission at Week 12.	Complete Symptomatic Remission is defined as a SFS of 0 and a RBS of 0.	At Week 12
Induction Phase: Percentage of Participants With Symptomatic Remission at Week 12.	Symptomatic Remission is defined as a SFS of 0 or 1 with a decrease of at least 1 from baseline and a RBS of 0.	At Week 12
Induction Phase: Percentage of Participants With Clinical Response at Week 12.	Clinical response is based on the Modified Mayo Score (mMS). The Modified Mayo Score (mMS) consists of Rectal Bleeding Subscore (RBS), Stool Frequency Subscore (SFS) and Mayo Endoscopic Subscore (MES). Each subscore ranges from 0 to 3 and a total mMS ranging from 0 to 9, with higher scores indicating more severe disease. Clinical Response is defined as a decrease in mMS of at least 2 points and 30% from baseline and either a decrease of at least 1 in RBS or a RBS of 0 or 1.	At Week 12
Induction Phase: Percentage of Participants With Endoscopic Response at Week 12.	Endoscopic Response is defined as a decrease of at least 1 in MES from baseline.	At Week 12
Induction Phase: Percentage of Participants With Symptomatic Response at Week 12.	Symptomatic Response is defined as a a decrease of ≥30% in the sum of RBS and SFS from baseline.	At Week 12
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 40.	Endoscopic Improvement is defined as MES of 0 or 1 (without friability).	At Week 40
Maintenance Phase: Percentage of Participants with a Clinical Remission both at Week 12 of Induction Phase and Week 40 of Maintenance Phase.	Clinical remission is defined as a SFS of 0 or 1 with a decrease of at least 1 from baseline , and a RBS of 0, and a MES of 0 or 1 without friability.	At Week 40
Maintenance Phase: Percentage of Participants With Steroid-free Clinical Remission at Week 40.	Steroid-free Clinical Remission is defined as achieving clinical remission and have not used corticosteroids to treat UC for at least 8 weeks.	At Week 40
Maintenance Phase: Percentage of Participants With Endoscopic Response at Week 40.	Endoscopic Response is defined as a decrease of at least 1 in MES from baseline.	At Week 40
Maintenance Phase: Percentage of Participants with a Clinical Response both at Week 12 of Induction Phase and Week 40 of Maintenance Phase.	Clinical Response is defined as a decrease in mMS of at least 2 points and 30% from baseline and either a decrease of at least 1 in RBS or a RBS of 0 or 1.	At Week 40
Maintenance Phase: Percentage of Participants With Complete Symptomatic Remission.	Complete Symptomatic Remission is defined as a SFS of 0 and a RBS of 0.	Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.
Maintenance Phase: Percentage of Participants With Symptomatic Remission.	Symptomatic Remission is defined as a SFS of 0 or 1 with a decrease of at least 1 from baseline and a RBS of 0.	Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.
Maintenance Phase:Percentage of Participants With Symptomatic Response.	Symptomatic Response is defined as a a decrease of ≥30% in the sum of RBS and SFS from baseline.	Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of calprotectin from baseline.		At Week 12 of Induction Phase and Week 40 of Maintenance Phase.
Among participants with abnormal calprotectin at baseline, percentage of participant with normalized calprotectin.		At Week 12 of Induction Phase and Week 40 of Maintenance Phase.
Change of modified Mayo score from baseline.	The Modified Mayo Score (mMS) consists of Rectal Bleeding Subscore (RBS), Stool Frequency Subscore (SFS) and Mayo Endoscopic Subscore (MES). Each subscore ranges from 0 to 3 and a total mMS ranging from 0 to 9, with higher scores indicating more severe disease.	At Week 12 of Induction Phase and at Week 40 of Maintenance Phase.
Change of partial modified Mayo score from baseline.	The partial modified Mayo Score (pmMS) consists of Rectal Bleeding Subscore (RBS) and Stool Frequency Subscore (SFS). Both RBS and SFS range from 0 to 3, with higher scores indicating more severe disease.	Induction Phase: At Week 2, Week 4, Week 8, Week 12. Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.
Change of IBDQ score from baseline.	The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.	At Week 12 of Induction Phase and at Week 40 of Maintenance Phase.
Among participants with abnormal C-reactive protein at baseline, percentage of participant with normalized C-reactive protein.		At Week 12 of Induction Phase and at Week 40 of Maintenance Phase.
Incidence and Severity of Adverse Events, Serious Adverse Events, Adverse Events Leading to Discontinuation, Adverse events of Special Interest.		From Week 0 of Induction Phase to Week 40 of Maintenance Phase

Collaborators and Investigators

• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Minhu Chen, M.D, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Hemay005
• Other Study ID Numbers: HM005UC3S01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No