A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
NCT ID: NCT05770609
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2023-06-19
2024-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPH3127 Tablets with Dose A
Oral daily dose of SPH3127 Tablets for up to 8 weeks
SPH3127 Tablets with Dose A
See Arm description
SPH3127 Tablets with Dose B
Oral daily dose of SPH3127 Tablets for up to 8 weeks
SPH3127 Tablets with Dose B
See Arm description
SPH3127 Tablets placebo
Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks
SPH3127 Tablets placebo
See Arm description
Interventions
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SPH3127 Tablets with Dose A
See Arm description
SPH3127 Tablets with Dose B
See Arm description
SPH3127 Tablets placebo
See Arm description
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Huizhou First Hospital
Huizhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guanmgdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Xi'an Central Hospital
Xi’an, Shanxi, China
Suining Central Hospital
Suining, Sichuan, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
Chifeng Municipal Hospital
Chifeng, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, , China
Tianjin Medical University General Hospital;
Tianjin, , China
Countries
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Other Identifiers
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SPH3127-203
Identifier Type: -
Identifier Source: org_study_id
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