drugset
drugset / Trial / NCT06725017

A Phase 2 Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Adult Patients with Active Mild to Moderate Ulcerative Colitis

NCT06725017 ↗

Phase 2 Not yet recruiting 60 enrolled Guangzhou Zhiyi Biotechnology Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to preliminarily evaluate the efficacy and safety of SK08 in adult patients with active mild to moderate UC. Each subject will undergo three study periods: screening, induction treatment period and a safety follow-up period.

Timeline

Start
2025-07-01
Primary completion
2027-07-01
Completion
2027-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject SK08 Other / unclassified 1e+07 unknown Oral
Subject SK08 Other / unclassified 2.5e+08 unknown Oral
Subject SK08 Other / unclassified 1e+09 unknown Oral
Subject SK08 Other / unclassified 2.5e+10 unknown Oral

Indications

ulcerative colitis