A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · Mar 5, 2023
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called SPH3127 to see how well it works for treating mild to moderate ulcerative colitis, a condition that causes inflammation in the digestive tract. Researchers want to find out if this medication is effective compared to a placebo, which is a pill that doesn’t contain the active drug. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with ulcerative colitis. To be eligible, individuals must agree to use birth control during the study and understand what participating in the trial involves.
Participants in this study will take either SPH3127 or a placebo and will be monitored by doctors to see how their condition changes. It's important to note that individuals with certain other health conditions, recent surgeries, or those who are pregnant or breastfeeding cannot take part in this trial. If you or someone you know is interested in participating, it’s a good idea to talk to a healthcare provider to learn more about the study and its potential benefits and risks.
Gender
ALL
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.
About Shanghai Pharmaceuticals Holding Co., Ltd
Shanghai Pharmaceuticals Holding Co., Ltd. is a leading integrated pharmaceutical company based in China, dedicated to the research, development, manufacturing, and distribution of a comprehensive range of pharmaceutical products. With a strong commitment to innovation and quality, the company focuses on advancing healthcare solutions through cutting-edge research and strategic collaborations. Shanghai Pharmaceuticals leverages its extensive expertise in drug development and a robust pipeline to address unmet medical needs, aiming to enhance patient outcomes and contribute to global health advancements. As a prominent player in the pharmaceutical industry, the company adheres to international standards and regulatory requirements, ensuring the highest levels of safety and efficacy in its clinical trials and product offerings.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Beijing, , China
Wuhan, Hubei, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Guangzhou, Guangdong, China
Yinchuan, Ningxia, China
Zhengzhou, , China
Wuhan, , China
Xuzhou, Jiangsu, China
Baoding, Hebei, China
Shenyang, Liaoning, China
Changsha, Hunan, China
Xi'an, Shanxi, China
Suining, Sichuan, China
Chifeng, , China
Hangzhou, , China
Jinan, Shandong, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Hengyang, Hunan, China
Beijing, , China
Shenyang, Liaoning, China
Shanghai, , China
Tianjin, , China
Huizhou, Guangdong, China
Guangzhou, Guanmgdong, China
Kai Feng, Henan, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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