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.
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.
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.
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.
Parallel
Hemay005 tablet
DrugParticipants receive treatment with Hemay005 tablet during the Induction Phase (week I-0\~I-12).
Placebo
DrugParticipants receive treatment with placebo tablet during the Induction Phase (week I-0\~I-12).
Hemay005 tablet
DrugParticipants receive treatment with Hemay005 tablet during the Maintenance Phase (week M-0\~M-40).
Placebo
DrugParticipants receive treatment with placebo during the Maintenance Phase (week M-0\~M-40).
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.
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.
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).
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.
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.
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.
Change of calprotectin from baseline.
Among participants with abnormal calprotectin at baseline, percentage of participant with normalized calprotectin.
Change of modified Mayo score from baseline.
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.
Change of partial modified Mayo score from baseline.
The partial modified Mayo Score (pmMS) consists of Rectal Bleeding Subscore (RBS) and Stool Frequency Subscore (SFS). Both RBS and SFS range from 0 to 3, with higher scores indicating more severe disease.
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