NCT05770609

A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.

Conditions

• Mild to Moderate Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SPH3127 Tablets with Dose A	See Arm description
DRUG	SPH3127 Tablets with Dose B	See Arm description
DRUG	SPH3127 Tablets placebo	See Arm description

Timeline

• Start date: 2023-06-19
• Primary completion: 2024-09-13
• Completion: 2024-09-13
• First posted: 2023-03-15
• Last updated: 2025-08-28

Locations

25 sites across 1 country: China