RecruitingPhase 3

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

China450 participantsStarted 2022-09-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg/m2, and 40kg≤ body weight ≤90kg; * For clinically diagnosed patients with tuberculosis whose drug sensitivity test has proved to be at least resistant to rifampicin, phenotypic or molecular drug sensitivity test results within 3 months before the subject signs informed consent can be accepted; * Direct sputum smear positive for acid-fast bacilli (AFB at least 1+); * Willing to discontinue all previous anti-tuberculosis drugs and accept a 7-day washout period; * Non-lactating and pregnant women who agree to use contraception throughout the treatment; Or the male patient's spouse agrees to use contraception throughout the treatment. Exclusion Criteria: * • Allergic to any study drug or its ingredients; * A history of alcohol dependence or drug abuse; * With hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis; * Drug susceptibility test before screening showed resistance to more than 4 of the 8 antituberculosis drugs in this study; * Have taken Bedaquiline before; * HIV-positive patients; * Laboratory obvious abnormalities; * A history of pointy torsion ventricular tachycardia or cardiac risk factors for pointy torsion ventricular tachycardia; * Repeated QTcF intervals \> 450ms; Clinically significant ventricular arrhythmias that may require medical or surgical treatment; * Documented cardiovascular diseases; * Peripheral neurop…

What they're measuring

Sputum Culture Conversion Rate at Week 24

Timeframe: Week 24

Trial details

NCT IDNCT05824871

SponsorShanghai Jiatan Pharmatech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-22

Contact for this trial

Naihui Chu, MD

010-89509312 dongchu1994@sina.com