A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Sponsored by Shanghai Jiatan Pharmatech Co., Ltd
About this trial
Last updated a year ago
Study ID
JYP0081M301
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 65 Years
All Sexes
Trial Timing
Started 4 years ago
What is this trial about?
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.
What are the participation requirements?
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 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.