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
- Diseases
- Ulcerative colitis
- 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
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Hebei University Coordinator of this site? Confirm its status | Baoding | China | Unknown status |
| Beijing Chao-Yang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Hunan University of Chinese Medicine Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chifeng Municipal Hospital Coordinator of this site? Confirm its status | Chifeng | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of University of South China Coordinator of this site? Confirm its status | Hengyang | China | Unknown status |
| Huizhou First Hospital Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The First Affiliated Hospital of Henan University Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| Shanghai Jiaotong University School of Medicine, Renji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital affiliated to China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xi'an Central Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.