NCT05824871RecruitingPhase 3
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Oral Sudapyridine (WX-081) Tablets in Patients With Rifampicin-Resistant Pulmonary Tuberculosis
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- First submitted
- 10 Apr 2023
- Start date
- 2 Sept 2022
- Primary completion date
- 22 Dec 2025
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Diseases
- Tuberculosis
- NCT number
- NCT05824871
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 450
- From 2 Sept 2022 to the primary completion date, 22 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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.
Who the study is looking for
- • 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing chest hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Chest Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Enrolling by invitation |
This page is information, not medical advice. Discuss any trial with your doctor.