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

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.

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.