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

Launched by SHANGHAI JIATAN PHARMATECH CO., LTD · Apr 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Sudapyridine (WX-081) to see how well it works and how safe it is for treating patients who have rifampicin-resistant pulmonary tuberculosis, which is a severe form of TB that doesn’t respond to standard treatments. The trial will involve about 450 participants who will be randomly assigned to receive either Sudapyridine or another treatment called bedaquiline for 24 weeks, along with a background regimen of other medicines. After this treatment period, participants will continue a background regimen for up to 72 weeks. Some participants will also take part in additional tests to monitor heart activity and how the body processes the medication.

To be eligible for this trial, participants need to be between 15 and 90 years old and have a specific body weight and body mass index (BMI). They must have a confirmed diagnosis of rifampicin-resistant TB and be willing to stop any current TB medications for a short period before the study starts. However, people with certain health conditions, such as serious heart problems or those who have previously taken bedaquiline, cannot participate. If you or someone you know is interested, this trial could offer a new treatment option for a challenging condition.

Gender

ALL

Eligibility criteria

• 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.