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

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.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Ulcerative Colitis
• Intervention / Treatment: Drug: SPH3127 Tablets with Dose A; Drug: SPH3127 Tablets with Dose B; Drug: SPH3127 Tablets placebo

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China, 100020
    • Beijing Chao-Yang Hospital,Capital Medical University
  • Chifeng, China
    • Chifeng Municipal Hospital
  • Hangzhou, China, 310003
    • The First Affiliated Hospital, Zhejiang University School of Medicine
  • Shanghai, China, 200001
    • Shanghai Jiaotong University School of Medicine, Renji Hospital
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital;
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital,Sun Yat-Sen University
    • Huizhou, Guangdong, China
      • Huizhou First Hospital
  • Guanmgdong
    • Guangzhou, Guanmgdong, China
      • Nanfang Hospital, Southern Medical University
  • He'nan
    • Zhengzhou, He'nan, China
      • the First Affiliated Hospital of Zhengzhou University
  • Hebei
    • Baoding, Hebei, China
      • Affiliated Hospital of Hebei University
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
  • Henan
    • Kaifeng, Henan, China
      • The First Affiliated Hospital of Henan University
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430000
      • Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • The First Hospital of Hunan University of Chinese Medicine
    • Hengyang, Hunan, China, 675299
      • The First Affiliated Hospital of University of South China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical University
  • Liaoning
    • Shenyang, Liaoning, China, 110136
      • Shengjing Hospital affiliated to China Medical University
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital Affiliated to Shandong First Medical University
  • Shanxi
    • Xi’an, Shanxi, China
      • Xi'an Central Hospital
  • Sichuan
    • Suining, Sichuan, China
      • Suining Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPH3127 Tablets with Dose A; Oral daily dose of SPH3127 Tablets for up to 8 weeks	Drug: SPH3127 Tablets with Dose A; See Arm description
Experimental: SPH3127 Tablets with Dose B; Oral daily dose of SPH3127 Tablets for up to 8 weeks	Drug: SPH3127 Tablets with Dose B; See Arm description
Placebo Comparator: SPH3127 Tablets placebo; Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks	Drug: SPH3127 Tablets placebo; See Arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom remission rate	Symptom remission rate	Week8
Endoscopic remission rate	Endoscopic remission rate	Week8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rate	Clinical remission rate	Week8
Symptom remission rate	Symptom remission rate	Week2、Week4
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

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs; SPH3127
• Other Study ID Numbers: SPH3127-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No