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

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroides Fragilis) in Adult Patients with Active Mild to Moderate Ulcerative Colitis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou Zhiyi Biotechnology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	Live SK08 powder	SK08 is an investigational live biotherapeutic product containing a nontoxigenic B. fragilis(NTBF) strain as an active ingredient.
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2024-12-09
• Last updated: 2024-12-16

Regulatory

• FDA-regulated drug study