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
1 other identifier
interventional
53
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2023
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedStudy Start
First participant enrolled
June 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2024
CompletedAugust 28, 2025
April 1, 2025
1.2 years
March 5, 2023
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Symptom remission rate
Symptom remission rate
Week8
Endoscopic remission rate
Endoscopic remission rate
Week8
Secondary Outcomes (3)
Clinical remission rate
Week8
Symptom remission rate
Week2、Week4
Safety and tolerability since the start of any study treatment.
Approximately 3 months
Study Arms (3)
SPH3127 Tablets with Dose A
EXPERIMENTALOral daily dose of SPH3127 Tablets for up to 8 weeks
SPH3127 Tablets with Dose B
EXPERIMENTALOral daily dose of SPH3127 Tablets for up to 8 weeks
SPH3127 Tablets placebo
PLACEBO COMPARATOROral daily dose of SPH3127 Tablets placebo for up to 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Huizhou First Hospital
Huizhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guanmgdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
Wuhan, Hubei, 430000, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 675299, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110136, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Xi'an Central Hospital
Xi’an, Shanxi, China
Suining Central Hospital
Suining, Sichuan, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, 100020, China
Peking University Third Hospital
Beijing, China
Chifeng Municipal Hospital
Chifeng, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, 310003, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, 200001, China
Tianjin Medical University General Hospital;
Tianjin, 300052, China
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2023
First Posted
March 15, 2023
Study Start
June 19, 2023
Primary Completion
September 13, 2024
Study Completion
September 13, 2024
Last Updated
August 28, 2025
Record last verified: 2025-04