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NCT05770609CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 28 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
53 (actual)
First submitted
5 Mar 2023
Start date
19 Jun 2023
Primary completion date
13 Sept 2024
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
NCT number
NCT05770609

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 53
  • From 19 Jun 2023 to the primary completion date, 13 Sept 2024
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 with a history of drug abuse with clinical significance within 1 year prior to screening;

Other illness

  • 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 with other diseases or conditions that the investigator considers unsuitable for this trial.

Other

  • Subjects and lactating women and those who will become pregnant within 6 months after the trial starts;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Hospital of Hebei University
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BaodingChinaUnknown status
Beijing Chao-Yang Hospital, Capital Medical University
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
The First Hospital of Hunan University of Chinese Medicine
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ChangshaChinaUnknown status
Chifeng Municipal Hospital
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ChifengChinaUnknown status
Nanfang Hospital, Southern Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The Sixth Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital of University of South China
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HengyangChinaUnknown status
Huizhou First Hospital
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HuizhouChinaUnknown status
Shandong Provincial Hospital Affiliated to Shandong First Medical University
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JinanChinaUnknown status
The First Affiliated Hospital of Henan University
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KaifengChinaUnknown status
Shanghai Jiaotong University School of Medicine, Renji Hospital
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ShanghaiChinaUnknown status
Shengjing Hospital affiliated to China Medical University
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ShenyangChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Suining Central Hospital
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SuiningChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Renmin Hospital of Wuhan University
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WuhanChinaUnknown status
Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
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WuhanChinaUnknown status
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaUnknown status
Xi'an Central Hospital
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Xi’anChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.