drugset / Trial / NCT05019742

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

NCT05019742 ↗

Phase 2 Terminated 3 enrolled Shanghai Pharma Biotherapeutics USA Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-03-21
Primary completion
2022-11-01
Completion
2022-11-01

Outcome

Outcome not reported

Stopped (Enrollment): “Shanghai Pharma Biotherapeutics USA Inc. experienced difficulty in recruiting clinical research sites and in enrolling patients with ulcerative colitis, and consequently, the study was terminated due to futility.”

Drugs

EvaluationDrugModalityDoseRoute
Subject sitokiren Small molecule 50 mg Oral
Subject sitokiren Small molecule 100 mg Oral

Indications