Ulcerative Colitis (UC)Phase 3NCT07650942
Hemay005 for the Treatment of Chinese Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Hemay005 tablet in people with Ulcerative Colitis (UC), run by Ganzhou Hemay Pharmaceutical Co., Ltd at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Hemay005 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2026to Feb 2029
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Conventional therapies, including oral 5-aminosalicylic acid (5-ASA) compounds, corticosteroids, immunoregulatory agents.
- 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.
Who cannot join
- 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:
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The First Affiliated Hospital,Sun Yat-Sen University
Guangzhou
Minhu Chen, M.D, 86-020-87755766, chenminhu@vip.163.com
Baili Chen
The Sixth Affiliated Hospital,Sun Yat-Sen University
Guangzhou
Xiang Gao, M.D, 86-020-38254000
Xiang Gao, M.D
About this study
Official title: 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.
Read the 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.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Hemay005 tablet, Placebo
- Keywords
- Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005 tabletDrug
Participants receive treatment with Hemay005 tablet during the Induction Phase (week I-0~I-12).
PlaceboDrug
Participants receive treatment with placebo tablet during the Induction Phase (week I-0~I-12).
Hemay005 tabletDrug
Participants receive treatment with Hemay005 tablet during the Maintenance Phase (week M-0~M-40).
PlaceboDrug
Participants receive treatment with placebo during the Maintenance Phase (week M-0~M-40).
| Study group | Role | What they receive |
|---|---|---|
| Induction Treatment Arm | Experimental | 60mg, administratered orally, twice daily Receives: Drug: Hemay005 tablet |
| Induction Comparator Arm | Placebo comparator | matching tablet, administratered orally, twice daily Receives: Drug: Placebo |
| Maintenance Treatment Arm | Experimental | 60mg, administratered orally, twice daily Receives: Drug: Hemay005 tablet |
| Maintenance Comparator Arm | Placebo comparator | matching tablet, administratered orally, twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Maintenance Phase: Week 40
Secondary outcomes (14)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minhu Chen, M.D, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650942
- Sponsor's protocol ID
- HM005UC3S01
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07650942
- Acronym / sponsor ID
- HM005UC3S01
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Inflammatory Bowel Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 Jun 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Induction Treatment Arm | Experimental | Drug: Hemay005 tablet60mg, administratered orally, twice daily |
| Induction Comparator Arm | Placebo comparator | Drug: Placebomatching tablet, administratered orally, twice daily |
| Maintenance Treatment Arm | Experimental | Drug: Hemay005 tablet60mg, administratered orally, twice daily |
| Maintenance Comparator Arm | Placebo comparator | Drug: Placebomatching tablet, administratered orally, twice daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- 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.
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 tabletParticipants receive treatment with Hemay005 tablet during the Induction Phase (week I-0~I-12). | Drug | Induction Treatment Arm |
| PlaceboParticipants receive treatment with placebo tablet during the Induction Phase (week I-0~I-12). | Drug | Induction Comparator Arm |
| Hemay005 tabletParticipants receive treatment with Hemay005 tablet during the Maintenance Phase (week M-0~M-40). | Drug | Maintenance Treatment Arm |
| PlaceboParticipants receive treatment with placebo during the Maintenance Phase (week M-0~M-40). | Drug | Maintenance Comparator Arm |
Primary outcome
Induction Phase: Percentage of Participants With Clinical Remission at Week 12.
Time frame: Induction Phase 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.
Maintenance Phase: Percentage of Participants With Clinical Remission at Week 40.
Time frame: Maintenance Phase: 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.
14 secondary outcomes
Induction Phase: Percentage of Participants With Endoscopic Improvement at Week 12.
Time frame: Induction Phase: At Week 12
Induction Phase: Percentage of Participants With Completely Symptomatic Remission at Week 12.
Time frame: At Week 12
Induction Phase: Percentage of Participants With Symptomatic Remission at Week 12.
Time frame: At Week 12
Induction Phase: Percentage of Participants With Clinical Response at Week 12.
Time frame: At Week 12
Induction Phase: Percentage of Participants With Endoscopic Response at Week 12.
Time frame: At Week 12
Induction Phase: Percentage of Participants With Symptomatic Response at Week 12.
Time frame: At Week 12
Maintenance Phase: Percentage of Participants With Endoscopic Improvement at Week 40.
Time frame: 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.
Time frame: At Week 40
Maintenance Phase: Percentage of Participants With Steroid-free Clinical Remission at Week 40.
Time frame: At Week 40
Maintenance Phase: Percentage of Participants With Endoscopic Response at Week 40.
Time frame: 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.
Time frame: At Week 40
Maintenance Phase: Percentage of Participants With Complete Symptomatic Remission.
Time frame: Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.
Maintenance Phase: Percentage of Participants With Symptomatic Remission.
Time frame: Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.
Maintenance Phase:Percentage of Participants With Symptomatic Response.
Time frame: Maintenance Phase: At Week 8, Week 16, Week 24, Week 32, Week 40.
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 16 Jun 2026.
- 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.
Minhu Chen, M.D principal investigator
First Affiliated Hospital, Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hemay005 tablet in people with Ulcerative Colitis (UC), run by Ganzhou Hemay Pharmaceutical Co., Ltd at 2 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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Han Hai (86-22-24929530, haihan@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction Phase: Percentage of Participants With Clinical Remission at Week 12. (time frame: Induction Phase Week 12). The study lists 2 primary outcomes in all. 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 16 Jun 2026.