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A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients

NCT05824871 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-06-29

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant pulmonary tuberculosis.

Approximately 450 participants will be screened over a period of up to 2 weeks and randomized in a 2:1 ratio to receive either Sudapyridine or bedaquiline, in combination with placebo tablets and BR, for 24 weeks. After the treatment period, participants will enter a background regimen period up to Week 72, during which they will continue to receive BR.

A subset of participants will be included in the C-QT sub-study to assess intensive PK sampling and 12-lead ECG evaluations on Day 1 pre-dose, Day 14, and Week 24.

The study aims to provide robust data to support the use of Sudapyridine as a treatment option for rifampicin-resistant pulmonary tuberculosis.

Conditions

  • Rifampin-Resistant Pulmonary Tuberculosis
  • Tuberculosis, Multidrug-Resistant (MDR-TB)

Interventions

DRUG

Sudapyridine

Sudapyridine (WX-081) will be administered as a loading dose for 2 weeks (450 mg once daily for 7 days, followed by 300 mg once daily for 7 days) and a maintenance dose (150 mg once daily) from Week 3 to Week 24. The intervention is combined with background regimen (BR) and placebo for bedaquiline.

DRUG

Bedaquiline

Bedaquiline will be administered as a loading dose for 2 weeks (400 mg once daily) and a maintenance dose (200 mg three times per week, with at least 48 hours between doses) from Week 3 to Week 24. The intervention is combined with background regimen (BR) and placebo for Sudapyridine.

Sponsors & Collaborators

  • Shanghai Jiatan Pharmatech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Naihui Chu, Ph.D · Beijing Chest Hospital affiliated to Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2025-12-22
Completion
2026-10-22

Countries

  • China

Study Locations

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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 NCT05824871 on ClinicalTrials.gov