Clinical trial NCT05770609: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Mild to Moderate Ulcerative Colitis
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptom remission rate
timeFrame: Week8
measure: Endoscopic remission rate
timeFrame: Week8
Secondary outcomes:
measure: Clinical remission rate
timeFrame: Week8
measure: Symptom remission rate
timeFrame: Week2、Week4
measure: Safety and tolerability since the start of any study treatment.
timeFrame: Approximately 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital，Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Huizhou
country: China
facility: Huizhou First Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guanmgdong
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Kai Feng
country: China
facility: The First Affiliated Hospital of Henan University
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shanxi
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital,Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital;
Study officials:
References: