A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis

Study Overview
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Brief Summary
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To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis

Conditions
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Mild to Moderate Ulcerative Colitis

Intervention / Treatment
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* Drug: SPH3127 Tablets with Dose A
* Drug: SPH3127 Tablets with Dose B
* Drug: SPH3127 Tablets placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 - 75 years, male or female; Subjects who have been diagnosed with ulcerative colitis； Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose; Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial. Exclusion Criteria: Subjects who are diagnosed with Crohn's disease or indeterminate colitis; Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects; Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period; Subjects and lactating women and those who will become pregnant within 6 months after the trial starts; Subjects with a history of drug abuse with clinical significance within 1 year prior to screening; Subjects with other diseases or conditions that the investigator considers unsuitable for this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPH3127 Tablets with Dose A<br>Oral daily dose of SPH3127 Tablets for up to 8 weeks | Drug: SPH3127 Tablets with Dose A<br>* See Arm description<br>|
| Experimental: SPH3127 Tablets with Dose B<br>Oral daily dose of SPH3127 Tablets for up to 8 weeks | Drug: SPH3127 Tablets with Dose B<br>* See Arm description<br>|
| Placebo Comparator: SPH3127 Tablets placebo<br>Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks | Drug: SPH3127 Tablets placebo<br>* See Arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom remission rate | Symptom remission rate | Week8 | 
| Endoscopic remission rate | Endoscopic remission rate | Week8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission rate | Clinical remission rate | Week8 | 
| Symptom remission rate | Symptom remission rate | Week2、Week4 | 
| Safety and tolerability since the start of any study treatment. | Incidence of adverse event and serious adverse event , correlation with study drug | Approximately 3 months |