Tests sudapyridine tablets in adults with rifampicin-resistant lung tuberculosis
Compares sudapyridine tablets with bedaquiline in adults with drug-resistant lung tuberculosis.
Plain-language title generated from the registry record
Registry title: A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Key facts
- Where
- Beijing, ChinaSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05824871, who can take part
Where in China
- Beijing Chest Hospital affiliated to Capital Medical UniversityBeijing, ChinaEnrolling by invitation
- Beijing chest hospital, Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Jiatan Pharmatech Co., Ltd
- Trial code
- NCT05824871
- Record updated
- 29 June 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: • 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: • 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 neuropathy CTCAE grade 3 or grade 4; Grade 1 or grade 2 neuropathy that the investigator believes is likely to progress/worsen over the course of the study; optic neuritis; Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.