Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05824871
PHASE3

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

Sponsor: Shanghai Jiatan Pharmatech Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2022-09-02

Completion Date

2026-10-22

Last Updated

2025-06-29

Healthy Volunteers

No

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.

Locations (2)

Beijing Chest Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China