Actively Recruiting
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-02-10
20
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 in Patients With Moderate-to-severe Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 75 years at screening
- Body mass index (BMI) of at least 18 kg/m² at screening
- Active ulcerative colitis with a modified Mayo score of 4-9, endoscopic subscore of 2 or more, and rectal bleeding subscore of 1 or more
- Ulcerative colitis diagnosis for at least 90 days before baseline
- Inadequate response, loss of response, or intolerance to at least one conventional treatment or previous exposure to anti-TNF or other biological treatments
- Able to provide signed informed consent
- Women of childbearing potential and their male partners must agree to use two methods of contraception during the study and for 72 weeks after last dose
You will not qualify if you...
- Diagnosis of indeterminate colitis or clinical signs suggestive of Crohn's disease
- Ulcerative colitis limited to proctitis (15 cm or less)
- Treatment-naïve to ulcerative colitis therapies such as oral 5-ASA, corticosteroids, immunosuppressants, or biological treatments
- Signs of ischemic colitis, fulminant colitis, or toxic megacolon
- Previous surgery for ulcerative colitis or likely to require surgery during the study
- History of gastrointestinal dysplasia or cancer except completely resected low-grade dysplasia
- Evidence of pathogenic bowel infection or positive test for intestinal pathogens within 30 days before screening
- Clinically significant infection within 1 month before baseline or infections judged risky for study participation
- Use of cyclosporine, mycophenolate, tacrolimus, JAK inhibitors within 4 weeks before baseline
- Interferon therapy within 8 weeks before baseline
- Use of intravenous corticosteroids, rectal corticosteroids, or 5-ASA within 2 weeks before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
T
Tingyu Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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