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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Guangzhou Zhiyi Biotechnology Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-01
Completion
2027-08-01
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725017 on ClinicalTrials.gov