NCT07232576

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Patients With Moderately to Severely Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SHR-1139 intravenous injection.	SHR-1139 intravenous injection.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-11-18
• Last updated: 2026-02-10

Locations

1 site across 1 country: China