NCT05824871

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

A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Oral Sudapyridine (WX-081) Tablets in Patients With Rifampicin-Resistant Pulmonary Tuberculosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase III clinical study is designed to evaluate the efficacy and safety of Sudapyridine (WX-081) in combination with a background regimen (BR) for the treatment of rifampicin-resistant pulmonary tuberculosis. The study will be conducted at multiple centers, employing a randomized, double-blind, active-controlled design. The study will consist of three phases: Screening Phase: Duration: Up to 2 weeks. Approximately 450 participants with rifampicin-resistant pulmonary tuberculosis will be screened for eligibility. Treatment Phase: Participants will be randomized in a 2:1 ratio into two groups: 1. Sudapyridine Group: Sudapyridine (WX-081) with placebo and BR. 2. Bedaquiline Group: Bedaquiline with placebo and BR. Treatment duration: 24 weeks. Background Regimen Phase: After completing the treatment phase, participants in both groups will continue to receive the background regimen (BR) until Week 72. The study aims to test the hypothesis that Sudapyridine (WX-081), when combined with a background regimen, is effective and safe for treating rifampicin-resistant pulmonary tuberculosis. The data collected from this study will include primary and secondary endpoints related to efficacy and safety, PK/PD data, and cardiac safety evaluations. The sample size of approximately 450 participants is designed to provide adequate power to detect a statistically significant difference in outcomes between treatment groups. Comprehensive data validation procedures and a robust statistical analysis plan will ensure the reliability and accuracy of the results.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-02
• Primary completion: 2025-12-22
• Completion: 2026-10-22
• First posted: 2023-04-24
• Last updated: 2025-06-29

Locations

2 sites across 1 country: China