Moderate to Severe Ulcerative ColitisPhase 2NCT05486104
Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis
A Phase 2 study testing Hemay005 tablets in people with Moderate to Severe Ulcerative Colitis, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Ulcerative Colitis
- What is being tested?
- Hemay005 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 18 sitesChina
- Study dates
- 8 Nov 2022to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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;
- Patients with hereditary immunodeficiency disease;
- Patients with a history of lymphoproliferative disorders (e.g. EBV-related lymphoproliferative disorders), or with lymphoma, leukemia, myeloproliferative disease, multiple myeloma;
- Lymphocyte apheresis or selective mononuclear granulocyte apheresis was performed within 12 months before the screening or is planned to be performed during the study;
- Patients with malignant tumor or with a history of malignancy other than well-treated or resected basal cell or squamous cell skin cancer;
- Patients with conditions that may affect oral drug absorption, e.g. gastrectomy or clinically significant diabetes-related gastrointestinal disorders, or specific types of obesity surgery such as gastric bypass, however, patients only subjected to the division of the stomach into independent chambers, like gastric banding, will not be excluded;
- Patients with previous surgery on small intestine or colon and with evidence of colonic dysplasia or intestinal stenosis;
- Patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) should be assessed for all patients during screening: patients with positive hepatitis B surface antigen (HBsAg) will be excluded; patients with HBsAg (negative), HBsAb (negative or positive) and HBcAb (positive) should be tested for HBV-DNA, and if the HBV-DNA result is positive, patient will be excluded; if the HBV-DNA result is negative, patients can be enrolled in the study.), chronic hepatitis C virus (HCV) infection (patients with positive hepatitis C virus antibody (HCVAb) excluded) or human immunodeficiency virus (HIV) infection (patients with positive human immunodeficiency virus (HIV) antibody excluded) or Syphilis (TP) infection (excluded patients with Treponema pallidum antibody (Anti-TP) positive);
- Patients receive any live vaccine at present or has received any live vaccine within 8 weeks prior to randomization, or have been vaccinated against COVID-19 within 14 days prior to randomization;
- Use of cytochrome P450 enzyme inducers (such as rifampicin, phenobarbital, dexamethasone, isoniazid, carbamazepine, etc.) within 14 days before screening;
- Suicidal behavior (including active attempts, interrupted attempts, or attempted attempts) or suicidal thoughts within the past 6 months;
- Other conditions that the investigator judges as unsuitable to participate in the study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing
Beijing Friendship Hospital Affiliated to Capital Medical University
Beijing
Peking University Third Hospital
Beijing
Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Chongqing People's Hospital
Chongqing
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Fourth Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Qilu Hospital of Shandong University
Jinan, Shandong
Shandong Provincial Hospital
Jinan, Shandong
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Shanghai Oriental Hospital
Shanghai
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning
Tianjin Medical University General Hospital
Tianjin
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Low-High Dosing Regimens of Hemay005 in Patients With Moderate to Severe Ulcerative Colitis
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.
Read the detailed description
This study adopts a multicenter, randomized, double-blind, low--high dose groups and placebo parallel controlled clinical study design. After screening, patients with active ulcerative colitis who meet the inclusion criteria and do not meet the exclusion criteria will be randomized by 1:1:1 to Hemay005 45 mg BID group, 60 mg BID group or placebo group, with proposed 36 patients in each group. All patients will enter a 12-week double-blind inductive treatment period. All randomized 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
- Being tested
- Hemay005 tablets, Hemay005 placebo tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005 tabletsDrug
Also called Hemay005 45 mg BID group
Hemay005 tablets (15mg/tablet）will be orally administered twice daily.
Hemay005 placebo tabletsDrug
Also called Hemay005 placebo BID group
Hemay005 placebo tablets will be orally administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Hemay005 45 mg BID group | Experimental | 3 tablets of Hemay005 (15mg/tablet) and 1 tablet of Hemay005 placebo will be orally administered twice daily. Receives: 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. Receives: Drug: Hemay005 tablets |
| Hemay005 placebo BID group | Placebo comparator | 4 tablets of Hemay005 placebo will be orally administered twice daily. Receives: Drug: Hemay005 placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 week
Secondary outcomes (1)
clinical response
Definition of clinical response: defined as a Mayo score reduction of ≥2 points from baseline and a decrease of ≥30% from baseline, with a reduction of ≥1 point from baseline in the rectal bleeding sub-score, or a rectal bleeding sub-score of ≤1 point.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start8 Nov 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shutian Zhang, MD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486104
- Sponsor's protocol ID
- HM005UC2S01
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Low-High Dosing Regimens of Hemay005 in Patients With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05486104
- Acronym / sponsor ID
- HM005UC2S01
- Conditions
- Moderate to Severe Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study adopts a multicenter, randomized, double-blind, low--high dose groups and placebo parallel controlled clinical study design. After screening, patients with active ulcerative colitis who meet the inclusion criteria and do not meet the exclusion criteria will be randomized by 1:1:1 to Hemay005 45 mg BID group, 60 mg BID group or placebo group, with proposed 36 patients in each group. All patients will enter a 12-week double-blind inductive treatment period. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Hemay005 45 mg BID group | Experimental | Drug: Hemay005 tablets, Drug: Hemay005 placebo tablets3 tablets of Hemay005 (15mg/tablet) and 1 tablet of Hemay005 placebo will be orally administered twice daily. |
| Hemay005 60 mg BID group | Experimental | Drug: Hemay005 tablets4 tablets of Hemay005 (15mg/tablet) will be orally administered twice daily. |
| Hemay005 placebo BID group | Placebo comparator | Drug: Hemay005 placebo tablets4 tablets of Hemay005 placebo will be orally administered twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemay005 tabletsAlso: Hemay005 45 mg BID groupHemay005 tablets (15mg/tablet）will be orally administered twice daily. | Drug | Hemay005 45 mg BID group, Hemay005 60 mg BID group |
| Hemay005 placebo tabletsAlso: Hemay005 placebo BID groupHemay005 placebo tablets will be orally administered twice daily. | Drug | Hemay005 45 mg BID group, Hemay005 placebo BID group |
Primary outcome
clinical remission
Time frame: 12 week
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).
1 secondary outcome
clinical response
Time frame: 12 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shutian Zhang, MD principal investigator
Beijing Friendship Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemay005 tablets in people with Moderate to Severe Ulcerative Colitis, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remission (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.