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Search / Trial NCT05770609

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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