Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

NCT05486104 | Active Not Recruiting Phase 2

• 1 other identifier: HM005UC2S01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 18

Brief 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

Outcome Measures

Primary Outcomes (1)

• clinical remission

  Definition of clinical remission rate: defined as a Mayo score of 0 or 1 in the number of bowel movements with a ≥1 reduction from baseline, a blood in the stool score of 0, and an endoscopic score of 0 or 1 (no fragility).

  12 week

Secondary Outcomes (1)

• clinical response

  12 week

Study Arms (3)

Hemay005 45 mg BID group

EXPERIMENTAL

3 tablets of Hemay005 (15mg/tablet) and 1 tablet of Hemay005 placebo will be orally administered twice daily.

Drug: Hemay005 tablets; Drug: Hemay005 placebo tablets

Hemay005 60 mg BID group

EXPERIMENTAL

4 tablets of Hemay005 (15mg/tablet) will be orally administered twice daily.

Drug: Hemay005 tablets

Hemay005 placebo BID group

PLACEBO COMPARATOR

4 tablets of Hemay005 placebo will be orally administered twice daily.

Drug: Hemay005 placebo tablets

Interventions

Hemay005 tablets DRUG

Hemay005 tablets (15mg/tablet）will be orally administered twice daily.

Also known as: Hemay005 45 mg BID group

Hemay005 45 mg BID group; Hemay005 60 mg BID group

Hemay005 placebo tablets DRUG

Hemay005 placebo tablets will be orally administered twice daily.

Also known as: Hemay005 placebo BID group

Hemay005 45 mg BID group; Hemay005 placebo BID group

Eligibility Criteria

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

You may qualify if:

• Willing to participate in the trial and signing the informed consent forms;
• Age ≥18 years old, male or female;
• Diagnosed as ulcerative colitis (UC) ≥ 3 months at screening with clinical manifestations and evidence of endoscopy and confirmed by histopathological reports;
• Expansion of the affected bowel segment beyond the rectum confirmed on endoscopy (affected bowel segment≥15cm);
• Moderate to severe ulcerative colitis with Modified Mayo clinical score (MMCS)≥ 4 points and ≤9 points, the Endoscopy subscore ≥ 2 points within 14 days before randomization and Stool Frequency subscore ≥ 1 point;
• UC treatment failure or intolerance (intolerance is defined as the discontinuation of drug use due to adverse reactions judged by the investigators) experienced by patients using at least one of the following:
• Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA); Oral administration of corticosteroids; Azathioprine or 6-mercaptopurine; Anti-TNF-α treatment: infliximab or adalimumab, etc.; - If the patient is using the following drugs to treat ulcerative colitis at the time of screening, it is necessary to receive stable treatment during the screening period and the following requirements during the study period are as follows: Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA) maintaining stable for at least ≥ 2 weeks prior to endoscopy during the screening period and maintaining stable during the study period; and/or Oral administration of low-dose corticosteroids (≤25 mg/d prednisolone or equivalent drug dose) maintaining stable for at least ≥ 2 weeks prior to endoscopy during the screening period;
• \- At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided).

You may not qualify if:

• Pregnant or lactating women, or women or men whose partners planning to become pregnant during the study;
• Knownto be allergic to any component of Hemay005 tablets (the main component is hemay005, and the main excipients are mannitol, low substituted hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate);
• Patients with suspected or confirmed Crohn's disease, undiagnosed types of colitis, fulminant colitis, toxic megacolon, microscopic colitis, ischemic colitis or radioactive colitis based on medical history and endoscopy and/or histological results;
• Patients with active EBV and/or CMV infection (EBV antibody IgM and/or EBV DNA positive); CMV antibody IgM and/or CMV DNA positive);
• Patients with the disease confined to the rectum (ulcerative proctitis) according to the endoscopy during screening;
• Patients who have undergone surgical treatment for ulcerative colitis or who require surgery during the study;
• Patients with active infection or positive pathogen test at the time of screening, and determined by the investigator to increase the risk of the subject, except for those with negative repeat test results and no symptoms of persistent infection (if time permits, during screening treatment and repeat testing);
• Patients receiving the following treatments:
• Patients who have used azathioprine/6-mercaptopurine, methotrexate within 7 days before randomization; Patients who have used cyclosporine, mycophenolate mofetil, tacrolimus/sirolimus within 4 weeks before randomization; Patients who have used interferon within 8 weeks before randomization; Patients who have received anti-TNF-α treatment within 8 weeks before randomization; Intravenous corticosteroids or rectal administration of corticosteroids or rectal administration of 5-ASA within 2 weeks prior to randomization; Patients who have used thalidomide within 8 weeks before randomization;Patients who have received antibiotic treatment within 1 week before randomization;
• Patients with active infection and judged by the investigator to increase the risk of the subjects;
• Patients with a history of TB or active TB (Investigator-judged signs or symptoms of active tuberculosis at screening):
• Screening was permitted if patients had a history of tuberculosis and had been cured by investigator assessment for at least 3 years prior to randomization; subjects with a negative T-cell test for tuberculosis infection (T-SPOT) at screening can be included in this study. Subjects who are T-SPOT positive during the screening period need to undergo tuberculosis-related clinical examinations (Tuberculosis-related clinical work performed within 12 weeks prior to randomization can be used directly for evaluation), if the tuberculosis-related clinical examination confirmed active tuberculosis, the subjects will not be eligible for this study. Subjects can be included in this study if the tuberculosis-related clinical examination confirms inactive tuberculosis. If the research center cannot perform T-SPOT test, TB screening by QuantiFERON-TB Gold test kit can also be accepted. The treatment of QuantiFERON-TB-Gold screening results is the same as that of T-SPOT.
• Patients with hemoglobin \<8 g/dL or hematocrit \<30%, white blood cells \<3.0 × 10\^9/L or neutrophils \<1.2 × 10\^9/L, platelets \<100 × 10\^09/L at screening;
• Total bilirubin (TBIL), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 upper limits of normal (ULN) at screening;
• Glomerular filtration rate (eGFR) ≤ 40 ml/min;

Sponsors & Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd: lead

Study Sites (18)

The Fourth Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, China

Location

Beijing Friendship Hospital Affiliated to Capital Medical University

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Chongqing People's Hospital

Chongqing, China

Location

Shanghai Oriental Hospital

Shanghai, China

Location

Tianjin Medical University General Hospital

Tianjin, China

Location

MeSH Terms

Interventions

Hemay005

Study Officials

• Shutian Zhang, MD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: November 8, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

CN (18)