Evaluating SPH3127 for treating 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

This study is testing a new medication called SPH3127 to see if it can help adults with mild to moderate ulcerative colitis feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (industry)
• Locations: 25 sites (Guangzhou, Guangdong and 24 other locations)
• Trial ID: NCT05770609 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of SPH3127, a renin inhibitor, in patients suffering from mild to moderate ulcerative colitis. Participants will receive either SPH3127 tablets at two different doses or a placebo to determine the recommended dosage and evaluate clinical efficacy. The study will include adults aged 18 to 75 who have been diagnosed with ulcerative colitis and will require informed consent before participation. The trial is designed to provide preliminary data on the treatment's potential benefits compared to a control group.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with mild to moderate ulcerative colitis.

Not a fit: Patients with Crohn's disease, indeterminate colitis, or those with active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with mild to moderate ulcerative colitis.

How similar studies have performed: While this approach is novel, similar studies evaluating renin inhibitors for inflammatory bowel diseases have shown promise.

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.

Where this trial is running

Guangzhou, Guangdong and 24 other locations

• The First Affiliated Hospital，Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Huizhou First Hospital — Huizhou, Guangdong, China (RECRUITING)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guanmgdong, China (RECRUITING)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (RECRUITING)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)
• The First Affiliated Hospital of Henan University — Kai Feng, Henan, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (RECRUITING)
• The First Hospital of Hunan University of Chinese Medicine — Changsha, Hunan, China (RECRUITING)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (RECRUITING)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (RECRUITING)
• Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China (RECRUITING)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (RECRUITING)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (RECRUITING)
• Xi'an Central Hospital — Xi'an, Shanxi, China (RECRUITING)
• Suining Central Hospital — Suining, Sichuan, China (RECRUITING)
• Beijing Chao-Yang Hospital,Capital Medical University — Beijing, China (RECRUITING)
• Peking University Third Hospital — Beijing, China (RECRUITING)
• Chifeng Municipal Hospital — Chifeng, China (RECRUITING)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (RECRUITING)
• Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai, China (RECRUITING)
• Tianjin Medical University General Hospital; — Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Minhu Chen

Conditions: Mild to Moderate Ulcerative Colitis