NCT07507513

The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of SSGJ-627 in Subjects With Moderate to Severe Active Ulcerative Colitis (UC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of 627 in patients with UC.

Detailed description

Ulcerative colitis (UC) is a chronic non-specific intestinal disease characterized by continuous and diffuse inflammatory changes in the colorectal mucosa. Despite the availability of advanced therapies, there remains a significant unmet medical need, such as inadequate or loss of response to one or more of the following therapies, corticosteroid dependence, or intolerance to one or more therapies. The purpose of this study is to evaluate the efficacy and safety of 627 in patients with moderate to severe UC.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	627	627 subcutaneous (SC) injection.
DRUG	Placebo	Placebo subcutaneous (SC) injection.

Timeline

• Start date: 2026-03-31
• Primary completion: 2029-02-28
• Completion: 2029-12-30
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: China