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
This trial does not accept healthy volunteersQualifiers
• 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
Design model
Parallel
Treatments tested in this trial
Sudapyridine
DrugSudapyridine (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.
Bedaquiline
DrugBedaquiline 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.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Sudapyridine (WX-081) GroupExperimental treatment 1 intervention
Group B: Bedaquiline GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sputum Culture Conversion Rate at Week 24
Proportion of participants achieving sputum culture conversion (SCC) at Week 24 of treatment, measured as a percentage.
Time frame
Week 24Secondary outcomes
1
Time to Sputum Culture Conversion
Time required for participants to achieve sputum culture conversion (SCC) during the study period.
Time frame
Up to Week 722
Treatment Success Rate at Week 72
Proportion of participants achieving treatment success at Week 72, based on predefined criteria.
Time frame
Week 723
Sputum Culture Conversion Rates at Multiple Time Points
Proportion of participants achieving sputum culture conversion at Weeks 8, 12, 16, 20, 36, 48, 60, and 72.
Time frame
Up to Week 72Sponsors and contacts
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Source ClinicalTrials.gov