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

April 2, 2024 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Shigang Ding
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chao-Yang Hospital,Capital medical university
        • Contact:
      • Chifeng, China
        • Recruiting
        • Chifeng Municipal Hospital
        • Contact:
          • Guoli Li
      • Hangzhou, China, 310003
        • Recruiting
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Chunxiao Chen
      • Shanghai, China, 200001
        • Recruiting
        • shanghai Jiaotong University School of Medicine, Renji Hospital
        • Contact:
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital;
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital,Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Huizhou, Guangdong, China
        • Recruiting
        • Huizhou First Hospital
        • Contact:
          • Xuanfang Zhong
    • Guanmgdong
      • Guangzhou, Guanmgdong, China
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Side Liu
    • Hebei
      • Baoding, Hebei, China
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
          • Jie Meng
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
          • Xiaolan Zhang
    • Henan
      • Kai Feng, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University
        • Contact:
          • Wenyi Yang
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Bingrong Liu
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Lei Shen
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The First Hospital of Hunan University of Chinese Medicine
        • Contact:
          • Bin Yu
        • Contact:
          • Hui Cao
      • Hengyang, Hunan, China, 675299
        • Recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital Of XuZhou Medical University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110136
        • Recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
          • Hongwei Xu
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • Xi'an Central Hospital
        • Contact:
          • Kun Zhuang
    • Sichuan
      • Suining, Sichuan, China
        • Recruiting
        • Suining Central Hospital
        • Contact:
          • Yong Yao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Week8
Symptom remission rate
Week8
Endoscopic remission rate
Time Frame: Week8
Endoscopic remission rate
Week8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission rate
Time Frame: Week8
Clinical remission rate
Week8
Symptom remission rate
Time Frame: Week2、Week4
Symptom remission rate
Week2、Week4
Safety and tolerability since the start of any study treatment.
Time Frame: Approximately 3 months

Incidence of adverse event and serious adverse event

, correlation with study drug
Approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2023

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

February 15, 2025

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 (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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