A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)
In brief
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.
Key facts
- Study ID
- NCT05824871
- Run by
- Shanghai Jiatan Pharmatech Co., Ltd
- People needed
- 450
- Starts
- 2022-09-02
- Expected to finish
- 2026-10-22
- Last updated by the study team
- 2025-06-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • 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.
You may not qualify if…
- • 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.
Where it is running
- Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Beijing Chest Hospital affiliated to Capital Medical University — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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