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

Mild to Moderate Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770609
• Other study ID #: SPH3127-203
• Status: Recruiting
• Phase: Phase 2
• Start date: June 19, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2024
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: Minhu Chen
• Phone: 0086-020-87755766
• Email: chenminhu[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged 18 - 75 years, male or female;

2. Subjects who have been diagnosed with ulcerative colitis;

3. 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;

4. 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:

1. Subjects who are diagnosed with Crohn's disease or indeterminate colitis;

2. Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects;

3. 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;

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

5. Subjects with a history of drug abuse with clinical significance within 1 year prior to screening;

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Mild to Moderate Ulcerative Colitis
• Ulcer

Intervention

Drug:
• SPH3127 Tablets with Dose A
See Arm description
• SPH3127 Tablets with Dose B
See Arm description
• SPH3127 Tablets placebo
See Arm description

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Beijing Chao-Yang Hospital,Capital Medical University	Beijing
China	Peking University Third Hospital	Beijing
China	The First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan
China	Chifeng Municipal Hospital	Chifeng
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guanmgdong
China	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	Huizhou First Hospital	Huizhou	Guangdong
China	Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	The First Affiliated Hospital of Henan University	Kai Feng	Henan
China	Shanghai Jiaotong University School of Medicine, Renji Hospital	Shanghai
China	Shengjing Hospital affiliated to China Medical University	Shenyang	Liaoning
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Suining Central Hospital	Suining	Sichuan
China	Tianjin Medical University General Hospital;	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology	Wuhan	Hubei
China	Xi'an Central Hospital	Xi'an	Shanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom remission rate	Symptom remission rate	Week8
Primary	Endoscopic remission rate	Endoscopic remission rate	Week8
Secondary	Clinical remission rate	Clinical remission rate	Week8
Secondary	Symptom remission rate	Symptom remission rate	Week2?Week4
Secondary	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