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New treatment option for Rifampin-Resistant Pulmonary Tuberculosis
Official title A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
ClinicalTrials.gov ID: NCT05824871
What this study is testing
What is Sudapyridine?
Sudapyridine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for rifampin-resistant pulmonary tuberculosis.
Also referred to as WX-081.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Body mass index (BMI) and body weight of people: 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...
- 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...
You likely can't join 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;
See the full eligibility criteria
- Body mass index (BMI) and body weight of people: 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.