A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Jiatan Pharmatech Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
• 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;
Disqualifiers
• 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;
Trial design
Treatments tested in this trial
- Sudapyridine
- Bedaquiline
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov