RecruitingPhase 2NCT07232576

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis

A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With moderate-to- Severe Active Ulcerative Colitis.


Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

20 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of SHR-1139 in patients with moderate to severe active ulcerative colitis. This study consists 2 treatment parts, the Induction treatment part and Maintenance treatment part. The periods of Induction treatment part and Maintenance treatment part are 12 weeks and 48 weeks separately.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SHR-1139 for people with moderate-to-severe active ulcerative colitis — a chronic inflammatory bowel disease causing sores and inflammation in the large intestine. Researchers want to see how well it works and how safe it is. **You may be eligible if...** - You are between 18 and 75 years old - You have had ulcerative colitis for at least 90 days and it is currently active - You have symptoms including rectal bleeding - Previous treatments like steroids, immunosuppressants, or biologic drugs have not worked well enough **You may NOT be eligible if...** - You are under 18 or over 75 years old - You are underweight (BMI below 18) - Your disease is not currently active or has been controlled - You have Crohn's disease rather than ulcerative colitis - You have a serious infection, liver disease, or other major health condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-1139 intravenous injection.

SHR-1139 intravenous injection.


Locations(1)

The First Affiliated Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT07232576


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