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

NCT05824871 | Recruiting Phase 3

• 1 other identifier: JYP0081M301
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

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

Rifampin-Resistant Pulmonary Tuberculosis; Tuberculosis, Multidrug-Resistant (MDR-TB)

Keywords

Rifampin-Resistant Tuberculosis; Multidrug-Resistant Tuberculosis (MDR-TB); Pulmonary Tuberculosis; Sudapyridine (WX-081); Bedaquiline; Antitubercular Agents; Randomized Controlled Trial; Background Regimen Therapy

Outcome Measures

Primary Outcomes (1)

• Sputum Culture Conversion Rate at Week 24

  Proportion of participants achieving sputum culture conversion (SCC) at Week 24 of treatment, measured as a percentage.

  Week 24

Secondary Outcomes (3)

• Time to Sputum Culture Conversion

  Up to Week 72

• Treatment Success Rate at Week 72

  Week 72

• Sputum Culture Conversion Rates at Multiple Time Points

  Up to Week 72

Study Arms (2)

Sudapyridine (WX-081) Group

EXPERIMENTAL

Participants in this group will receive Sudapyridine (WX-081) combined with background regimen (BR). Treatment starts with a loading dose of Sudapyridine for 2 weeks (450 mg once daily for 7 days, followed by 300 mg once daily for 7 days). This is followed by a maintenance dose of 150 mg once daily from Week 3 to Week 24. During the 24-week treatment period, participants will also receive a placebo for bedaquiline and continue their background regimen (BR). After the 24-week treatment period, participants will enter the background regimen phase and continue BR until Week 72.

Drug: Sudapyridine

Bedaquiline Group

ACTIVE COMPARATOR

Participants in this group will receive Bedaquiline combined with background regimen (BR). Treatment starts with a loading dose of Bedaquiline for 2 weeks (400 mg once daily), followed by a maintenance dose of 200 mg three times per week (with at least 48 hours between doses) from Week 3 to Week 24. During the 24-week treatment period, participants will also receive a placebo for Sudapyridine and continue their background regimen (BR). After the 24-week treatment period, participants will enter the background regimen phase and continue BR until Week 72.

Drug: Bedaquiline

Interventions

Sudapyridine DRUG

Sudapyridine (WX-081) will be administered as a loading dose for 2 weeks (450 mg once daily for 7 days, followed by 300 mg once daily for 7 days) and a maintenance dose (150 mg once daily) from Week 3 to Week 24. The intervention is combined with background regimen (BR) and placebo for bedaquiline.

Also known as: WX-081

Sudapyridine (WX-081) Group

Bedaquiline DRUG

Bedaquiline will be administered as a loading dose for 2 weeks (400 mg once daily) and a maintenance dose (200 mg three times per week, with at least 48 hours between doses) from Week 3 to Week 24. The intervention is combined with background regimen (BR) and placebo for Sudapyridine.

Bedaquiline Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai Jiatan Pharmatech Co., Ltd: lead

Study Sites (2)

Beijing Chest Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 101149, China

ENROLLING BY INVITATION

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Multidrug-Resistant; Tuberculosis, Pulmonary

Interventions

sudapyridine; bedaquiline

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Naihui Chu, Ph.D

  Beijing Chest Hospital affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naihui Chu, MD

CONTACT

010-89509312; dongchu1994@sina.com

Zhao Jie, Ph.D

CONTACT

86010-89509157; jiaojie_zhao@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors will be blinded to the intervention assignments to ensure unbiased assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized into two groups (Sudapyridine and Bedaquiline) for parallel treatment evaluation.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 24, 2023
• Study Start: September 2, 2022
• Primary Completion: December 22, 2025
• Study Completion (Estimated): October 22, 2026
• Last Updated: June 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)