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

Primary Purpose

Mild to Moderate Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SPH3127 Tablets with Dose A
SPH3127 Tablets with Dose B
SPH3127 Tablets placebo
Sponsored by
Shanghai Pharmaceuticals Holding Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • The First Affiliated Hospital，Sun Yat-sen UniversityRecruiting
  • The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The Third Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Huizhou First HospitalRecruiting
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Union Hospital Tongji Medical College Huazhong Universitu of Science and TechnologyRecruiting
  • Tongji Hospital Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • The First Affiliated Hospital of University of South ChinaRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • Shengjing Hospital affiliated to China Medical UniversityRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Beijing Chao-Yang Hospital,Capital Medical UniversityRecruiting
  • Peking University Third HospitalRecruiting
  • Chifeng Municipal HospitalRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • Shanghai Jiaotong University School of Medicine, Renji HospitalRecruiting
  • Tianjin Medical University General Hospital;Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SPH3127 Tablets with Dose A

SPH3127 Tablets with Dose B

SPH3127 Tablets placebo

Arm Description

Oral daily dose of SPH3127 Tablets for up to 8 weeks

Oral daily dose of SPH3127 Tablets for up to 8 weeks

Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks

Outcomes

Primary Outcome Measures

Symptom remission rate
Symptom remission rate
Endoscopic remission rate
Endoscopic remission rate

Secondary Outcome Measures

Clinical remission rate
Clinical remission rate
Symptom remission rate
Symptom remission rate
Safety and tolerability since the start of any study treatment.
Incidence of adverse event and serious adverse event , correlation with study drug

Full Information

First Posted
March 5, 2023
Last Updated
June 20, 2023
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05770609
Brief Title
A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPH3127 Tablets with Dose A
Arm Type
Experimental
Arm Description
Oral daily dose of SPH3127 Tablets for up to 8 weeks
Arm Title
SPH3127 Tablets with Dose B
Arm Type
Experimental
Arm Description
Oral daily dose of SPH3127 Tablets for up to 8 weeks
Arm Title
SPH3127 Tablets placebo
Arm Type
Placebo Comparator
Arm Description
Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
SPH3127 Tablets with Dose A
Intervention Description
See Arm description
Intervention Type
Drug
Intervention Name(s)
SPH3127 Tablets with Dose B
Intervention Description
See Arm description
Intervention Type
Drug
Intervention Name(s)
SPH3127 Tablets placebo
Intervention Description
See Arm description
Primary Outcome Measure Information:
Title
Symptom remission rate
Description
Symptom remission rate
Time Frame
Week8
Title
Endoscopic remission rate
Description
Endoscopic remission rate
Time Frame
Week8
Secondary Outcome Measure Information:
Title
Clinical remission rate
Description
Clinical remission rate
Time Frame
Week8
Title
Symptom remission rate
Description
Symptom remission rate
Time Frame
Week2、Week4
Title
Safety and tolerability since the start of any study treatment.
Description
Incidence of adverse event and serious adverse event , correlation with study drug
Time Frame
Approximately 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minhu Chen
Phone
0086-020-87755766
Email
chenminhu@vip.163.com
Facility Information:
Facility Name
The First Affiliated Hospital，Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minhu Chen
Phone
0086-020-87755766
Email
chenminhu@vip.163.com
Facility Name
The Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Gao
Phone
0086-020-38379764
Email
zslyllb-@mail.sysu.edu.cn
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingsong Li
Facility Name
Huizhou First Hospital
City
Huizhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuanfang Zhong
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolan Zhang
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bingrong Liu
Facility Name
Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Hou
Phone
0086-027-85726375
Email
whunionlunli@126.com
Facility Name
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Liu
Phone
0086-027-83691785
Email
tongjilunli@163.com
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Shen
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
675299
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aijun Liao
Phone
0086-13789353900
Email
nhfyllwyh@163.com
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujuan Fei
Phone
0086-0516-85802291
Email
xck2330@163.com
Facility Name
Shengjing Hospital affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110136
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changqing Zheng
Phone
0086-02496615-10027
Email
sunw1@sj-hospital.org
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoqi Yang
Phone
0086-0951-6743648
Email
nyfygk@126.com
Facility Name
Beijing Chao-Yang Hospital,Capital Medical University
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyu Hao
Phone
0086-010-85231484
Email
chaoyangyuanban@126.com
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigang Ding
Facility Name
Chifeng Municipal Hospital
City
Chifeng
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoli Li
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunxiao Chen
Facility Name
Shanghai Jiaotong University School of Medicine, Renji Hospital
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyuan Fang
Phone
0086-021-58752345
Email
chobits86422@aliyun.com
Facility Name
Tianjin Medical University General Hospital;
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bangmao Wang
Phone
0086-022-60361044
Email
master@tjmugh.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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