A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
- Conditions
- Mild to Moderate Ulcerative Colitis
- Interventions
- Drug: SPH3127 Tablets with Dose ADrug: SPH3127 Tablets with Dose BDrug: SPH3127 Tablets placebo
- Registration Number
- NCT05770609
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 108
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPH3127 Tablets with Dose A SPH3127 Tablets with Dose A Oral daily dose of SPH3127 Tablets for up to 8 weeks SPH3127 Tablets with Dose B SPH3127 Tablets with Dose B Oral daily dose of SPH3127 Tablets for up to 8 weeks SPH3127 Tablets placebo SPH3127 Tablets placebo Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks
- Primary Outcome Measures
Name Time Method Symptom remission rate Week8 Symptom remission rate
Endoscopic remission rate Week8 Endoscopic remission rate
- Secondary Outcome Measures
Name Time Method Clinical remission rate Week8 Clinical remission rate
Symptom remission rate Week2、Week4 Symptom remission rate
Safety and tolerability since the start of any study treatment. Approximately 3 months Incidence of adverse event and serious adverse event
, correlation with study drug
Trial Locations
- Locations (25)
The First Affiliated Hospital of University of South China
🇨🇳Hengyang, Hunan, China
Peking University Third Hospital
🇨🇳Beijing, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Huizhou First Hospital
🇨🇳Huizhou, Guangdong, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital，Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University
🇨🇳Kai Feng, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Shengjing Hospital affiliated to China Medical University
🇨🇳Shenyang, Liaoning, China
Xi'an Central Hospital
🇨🇳Xi'an, Shanxi, China
Beijing Chao-Yang Hospital,Capital Medical University
🇨🇳Beijing, China
Suining Central Hospital
🇨🇳Suining, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
🇨🇳Shanghai, China
Chifeng Municipal Hospital
🇨🇳Chifeng, China
Tianjin Medical University General Hospital;
🇨🇳Tianjin, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guanmgdong, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
The First Hospital of Hunan University of Chinese Medicine
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China