NCT05019742

Evaluation of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis

A Double-Blind, Placebo-Controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SPH3127 in Patients With Mild-to-Moderate Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Shanghai Pharma Biotherapeutics USA Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

SPH3127-US-01 is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy of SPH3127 for the treatment of mild-to-moderate ulcerative colitis.

Detailed description

SPH3127-US-01 is a proof-of-concept multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics, and preliminary efficacy of of daily oral administration of SPH3127 or placebo for 8 weeks in patients with mild-to-moderate ulcerative colitis. After meeting all inclusion and exclusion criteria, eligible patients will be randomized to receive SPH3127 (50 mg daily, 50 mg twice daily) or placebo tablets; all patients will take 2 tablets (SPH3127 or placebo) twice a day for 8 weeks. All randomized subjects will have the opportunity to enter an active-treatment extension (50 mg SPH3127 once or twice daily) for an additional 10 months.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SPH3127	SPH3127 - selective renin inhibitor
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-03-21
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-08-25
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study