Actively Recruiting
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Led by Shanghai Jiatan Pharmatech Co., Ltd · Updated on 2025-06-29
450
Participants Needed
2
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 15.0 and 28.0 kg/m2 and body weight between 40 kg and 90 kg
- Confirmed rifampicin-resistant pulmonary tuberculosis by phenotypic or molecular drug sensitivity tests within 3 months before consent
- Positive direct sputum smear for acid-fast bacilli (AFB at least 1+)
- Willingness to stop all previous anti-tuberculosis drugs and accept a 7-day washout period
- Non-lactating and non-pregnant women agreeing to use contraception during treatment or male patients whose spouses agree to use contraception during treatment
You will not qualify if you...
- Allergy to any study drug or its ingredients
- History of alcohol dependence or drug abuse
- Presence of hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis
- Resistance to more than 4 of the 8 antituberculosis drugs in this study as shown by drug susceptibility test
- Previous use of Bedaquiline
- HIV positive status
- Significant laboratory abnormalities
- History or risk factors for pointy torsion ventricular tachycardia
- Repeated QTcF intervals > 450 ms or clinically significant ventricular arrhythmias
- Documented cardiovascular diseases
- Peripheral neuropathy grade 3 or 4, or grade 1 or 2 neuropathy likely to worsen, or optic neuritis
- Any serious cardiovascular, kidney, liver, blood, tumor, endocrine, metabolic, autoimmune, or rheumatic diseases
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 101149
Enrolling by Invitation
2
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149
Actively Recruiting
Research Team
N
Naihui Chu, MD
CONTACT
Z
Zhao Jie, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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