Ulcerative ColitisPhase 2NCT03977480
Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis
A Phase 2 study testing Hemay007 in people with Ulcerative Colitis, run by Tianjin Hemay Pharmaceutical Co., Ltd at 25 sites in China.
Trial summary
This study adopts a multicenter, randomized, double-blind, low-medium-high dose group 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 1:1:1:1 to Hemay007 400 mg… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Hemay007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 25 sitesChina
- Study dates
- 13 Aug 2019to 12 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- 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 and ≤70 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;
- Active ulcerative colitis with full Mayo score ≥ 4 points, and the subscore "endoscopic findings" in the Mayo endoscopic score within 14 days before randomization ≥ 2 points;
- 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.;
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- 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 planning to become pregnant during the study;
- Knownto be allergic to any component of Hemay007 tablets (the main component is hemay007, and the main excipients are microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, 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 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;
- Patientswith evidence of pathogenic intestinal infection;
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- 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 positive mycobacterium tuberculosis or potential mycobacterium tuberculosis infection, i.e. patients conforming to any one of the following definitions will be excluded: QuantiFERON®-TB Gold (QFT-G) or T-SPOT.TB test positive or purified protein derivative (PPD) skin test induration result ≥ 5 mm (within 3 months before screening); Chest imaging examination indicating positive tuberculosis (TB) infection lesion within 3 months prior to screening; History of latent or active TB infection;
- 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;
- Patients previously receiving drugs or treatment depleting lymphocytes (e.g. alemtuzumab, alkylating agents (e.g. cyclophosphamide or chlorambucil), total lymph node radiotherapy, etc.), however, patients can be enrolled if they used rituximab or other selective B lymphocyte depleting drugs more than one year before screening;
- Lymphocyte apheresis or selective mononuclear granulocyte apheresis was performed within 12 months before the screening or is planned to be performed during the study;
- The electrocardiogram during the screening period is abnormal and clinically significant, with the safety risk possibly increasing judged by the investigator;
- Blood donation ≥500 ml within 2 months before randomization;
- 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; [21] 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);
- Varicella, herpes zoster or other serious viral infections within 6 weeks prior to screening;
- Patients receive any live vaccine at present or has received any live vaccine within 8 weeks prior to randomization;
- Major organ transplantation (e.g. heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
- Application of other drugs or devices of research nature within 3 months prior to randomization;
- Patients with primary sclerosing cholangitis;
- History of alcohol or drug abuse;
- Other conditions that the investigator judges as unsuitable to participate in the study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Peking University International Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
XiangYa Hospital CentralSouth University
Changsha, Hunan
Army Special Medical Center
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Army Military Medical University
Chongqing, Chongqing Municipality
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Neimenggu
Shandong Provincial Hospital
Jinan, Shandong
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Gulou Hospital Affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Tongji hospital, tongji medical college, huazhong university of science and technology
Wuhan, Hubei
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Affiliated Hospital of Qinghai University
Xining, Qinghai
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhengzhou People's Hospital
Zhengzhou, Henan
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis
This study adopts a multicenter, randomized, double-blind, low-medium-high dose group 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 1:1:1:1 to Hemay007 400 mg BID group, 800 mg QD group, 600 mg BID group or placebo group, with proposed 72 cases in each group. After 12 weeks of double-blind inductive treatment period, the patients will enter the Hemay007 open treatment period of 12 weeks when Hemay007 600 mg BID will be used as the medication regimen. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.
Read the detailed description
his study adopts a multicenter, randomized, double-blind, low-medium-high dose group 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 1:1:1:1 to Hemay007 400 mg BID group, 800 mg QD group, 600 mg BID group or placebo group, with proposed 72 cases in each group. After 12 weeks of double-blind inductive treatment period, the patients will enter the Hemay007 open treatment period of 12 weeks when Hemay007 600 mg BID will be used as the medication regimen. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.
- Conditions
- Ulcerative Colitis
- Being tested
- Hemay007, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay007Drug
Hemay007 will be orally administered.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Hemay007 400 mg BID group | Active comparator | Patients will orally take Hemay007 tablets 400 mg BID for 12 weeks. Receives: Drug: Hemay007 |
| Hemay007 800 mg QD group | Active comparator | Patients will orally take Hemay007 tablets 800 mg QD for 12 weeks. Receives: Drug: Hemay007 |
| Hemay007 600 mg BID group | Active comparator | Patients will orally take Hemay007 tablets 600 mg BID for 12 weeks. Receives: Drug: Hemay007 |
| placebo group | Placebo comparator | Patients will orally take placebo tablets for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response
12-week clinical response rate Definition of clinical response: defined as full Mayo score decreased by ≥ 3 points compared with baseline and lowered by ≥ 30% compared with baseline, combined with the rectal bleeding subscore decreased by ≥ 1 point compared with baseline, or the absolute value of rectal bleeding subscore ≤ 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 posted6 Jun 2019
- Study start13 Aug 2019
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Why it stopped: Due to the difficulty to recruit enough patients, the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaowei Liu, M.D., Principal investigator, XiangYa Hospital CentralSouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977480
- Sponsor's protocol ID
- HM007UC2S01
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2019
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. 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 Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03977480
- Acronym / sponsor ID
- HM007UC2S01
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the difficulty to recruit enough patients, the study was terminated.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tianjin Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 6 Jun 2019 (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 adopts a multicenter, randomized, double-blind, low-medium-high dose group 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 1:1:1:1 to Hemay007 400 mg BID group, 800 mg QD group, 600 mg BID group or placebo group, with proposed 72 cases in each group. After 12 weeks of double-blind inductive treatment period, the patients will enter the Hemay007 open treatment period of 12 weeks when Hemay007 600 mg BID will be used as the medication regimen. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.
Detailed description
his study adopts a multicenter, randomized, double-blind, low-medium-high dose group 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 1:1:1:1 to Hemay007 400 mg BID group, 800 mg QD group, 600 mg BID group or placebo group, with proposed 72 cases in each group. After 12 weeks of double-blind inductive treatment period, the patients will enter the Hemay007 open treatment period of 12 weeks when Hemay007 600 mg BID will be used as the medication regimen. 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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemay007 400 mg BID group | Active comparator | Drug: Hemay007Patients will orally take Hemay007 tablets 400 mg BID for 12 weeks. |
| Hemay007 800 mg QD group | Active comparator | Drug: Hemay007Patients will orally take Hemay007 tablets 800 mg QD for 12 weeks. |
| Hemay007 600 mg BID group | Active comparator | Drug: Hemay007Patients will orally take Hemay007 tablets 600 mg BID for 12 weeks. |
| placebo group | Placebo comparator | Drug: PlaceboPatients will orally take placebo tablets for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing to participate in the trial and signing the informed consent forms;
- Age ≥18 years old and ≤70 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;
- Active ulcerative colitis with full Mayo score ≥ 4 points, and the subscore "endoscopic findings" in the Mayo endoscopic score within 14 days before randomization ≥ 2 points;
- 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:
Key exclusion criteria (28 listed)
- Pregnant or lactating women, or women planning to become pregnant during the study;
- Knownto be allergic to any component of Hemay007 tablets (the main component is hemay007, and the main excipients are microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, 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 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;
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 |
|---|---|---|
| Hemay007Hemay007 will be orally administered. | Drug | Hemay007 400 mg BID group, Hemay007 600 mg BID group, Hemay007 800 mg QD group |
| PlaceboPlacebo | Drug | placebo group |
Primary outcome
clinical response
Time frame: 12-week
12-week clinical response rate Definition of clinical response: defined as full Mayo score decreased by ≥ 3 points compared with baseline and lowered by ≥ 30% compared with baseline, combined with the rectal bleeding subscore decreased by ≥ 1 point compared with baseline, or the absolute value of rectal bleeding subscore ≤ 1 point.
Results and safety
The study was stopped early (reason given: Due to the difficulty to recruit enough patients, the study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Xiaowei Liu, M.D. principal investigator
XiangYa Hospital CentralSouth University
25 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 Hemay007 in people with Ulcerative Colitis, run by Tianjin Hemay Pharmaceutical Co., Ltd at 25 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 10 inclusion and 28 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: stopped early, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
The study was stopped early (reason given: Due to the difficulty to recruit enough patients, the study was terminated.). Results are not available in the source record.
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 response (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 1 Mar 2024.