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

NCT07650942 | Not Yet Recruiting Phase 3

• 1 other identifier: HM005UC3S01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Induction Phase: Percentage of Participants With Endoscopic Improvement at Week 12.

  Induction Phase: At Week 12

• Induction Phase: Percentage of Participants With Completely Symptomatic Remission at Week 12.

  At Week 12

• Induction Phase: Percentage of Participants With Symptomatic Remission at Week 12.

  At Week 12

• Induction Phase: Percentage of Participants With Clinical Response at Week 12.

  At Week 12

• Induction Phase: Percentage of Participants With Endoscopic Response at Week 12.

  At Week 12

Other Outcomes (7)

• 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.

  At Week 12 of Induction Phase and at Week 40 of Maintenance Phase.

Study Arms (4)

Induction Treatment Arm

EXPERIMENTAL

60mg, administratered orally, twice daily

Drug: Hemay005 tablet

Induction Comparator Arm

PLACEBO COMPARATOR

matching tablet, administratered orally, twice daily

Drug: Placebo

Maintenance Treatment Arm

EXPERIMENTAL

60mg, administratered orally, twice daily

Drug: Hemay005 tablet

Maintenance Comparator Arm

PLACEBO COMPARATOR

matching tablet, administratered orally, twice daily

Drug: Placebo

Interventions

Hemay005 tablet DRUG

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

Induction Treatment Arm

Placebo DRUG

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

Induction Comparator Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 18 to 80 years of age, inclusive, at the time of consent.
• Voluntarily to give written informed consent.
• 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.
• Active UC confirmed by endoscopy, classified as Montreal E2 or E3.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.
• 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.
• 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).
• Evidence of active tuberculosis (TB).
• Any condition that would preclude endoscopic evaluation.
• 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.

Sponsors & Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd: lead

Study Sites (2)

The First Affiliated Hospital,Sun Yat-Sen University

Guangzhou, China

Location

The Sixth Affiliated Hospital,Sun Yat-Sen University

Guangzhou, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Hemay005

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Minhu Chen, M.D

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Hai

CONTACT

86-22-24929530; haihan@hemay.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)