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

PHASE3RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

September 2, 2022

Primary Completion Date

December 22, 2025

Study Completion Date

October 22, 2026

Conditions
Rifampin-Resistant Pulmonary TuberculosisTuberculosis, 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.

Trial Locations (2)

101149

ENROLLING_BY_INVITATION

Beijing Chest Hospital affiliated to Capital Medical University, Beijing

RECRUITING

Beijing Chest Hospital, Capital Medical University, Beijing

All Listed Sponsors
lead

Shanghai Jiatan Pharmatech Co., Ltd

INDUSTRY