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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05019742
Study type	Interventional
Source	Shanghai Pharma Biotherapeutics USA Inc.
Contact	Kenneth W Locke, PhD
Phone	8587755354
Email	kenneth@sphbio.com
Status	Recruiting
Phase	Phase 2
Start date	March 21, 2022
Completion date	December 2025

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