Rifampin-Resistant Pulmonary TuberculosisPhase 3WISHNCT05824871
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
A Phase 3 study testing Sudapyridine and Bedaquiline in people with Rifampin-Resistant Pulmonary Tuberculosis and Tuberculosis, Multidrug-Resistant (MDR-TB), run by Shanghai Jiatan Pharmatech Co., Ltd at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)
- What is being tested?
- Sudapyridine and Bedaquiline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesChina
- Study dates
- 2 Sep 2022to 22 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Enrolling by invitation
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 101149
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
Chu Nai Hui, M.D, +86-010-89509312, dongchu@sina.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
This Phase III clinical study is designed to evaluate the efficacy and safety of Sudapyridine (WX-081) in combination with a background regimen (BR) for the treatment of rifampicin-resistant pulmonary tuberculosis. The study will be conducted at multiple centers, employing a randomized, double-blind, active-controlled design.
The study will consist of three phases:
Screening Phase:
Duration: Up to 2 weeks. Approximately 450 participants with rifampicin-resistant pulmonary tuberculosis will be screened for eligibility.
Treatment Phase:
Participants will be randomized in a 2:1 ratio into two groups:
- Sudapyridine Group: Sudapyridine (WX-081) with placebo and BR.
- Bedaquiline Group: Bedaquiline with placebo and BR. Treatment duration: 24 weeks.
Background Regimen Phase:
After completing the treatment phase, participants in both groups will continue to receive the background regimen (BR) until Week 72.
The study aims to test the hypothesis that Sudapyridine (WX-081), when combined with a background regimen, is effective and safe for treating rifampicin-resistant pulmonary tuberculosis. The data collected from this study will include primary and secondary endpoints related to efficacy and safety, PK/PD data, and cardiac safety evaluations.
The sample size of approximately 450 participants is designed to provide adequate power to detect a statistically significant difference in outcomes between treatment groups. Comprehensive data validation procedures and a robust statistical analysis plan will ensure the reliability and accuracy of the results.
- Being tested
- Sudapyridine, Bedaquiline
- Keywords
- Rifampin-Resistant Tuberculosis, Multidrug-Resistant Tuberculosis (MDR-TB), Pulmonary Tuberculosis, Sudapyridine (WX-081), Bedaquiline, Antitubercular Agents, Randomized Controlled Trial, Background Regimen Therapy
- Medical subject headings
- Tuberculosis, Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SudapyridineDrug
Also called WX-081
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.
BedaquilineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bedaquiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Culture Conversion Rate at Week 24
Proportion of participants achieving sputum culture conversion (SCC) at Week 24 of treatment, measured as a percentage.
Measured: Week 24
Secondary outcomes (3)
Time to Sputum Culture Conversion
Time required for participants to achieve sputum culture conversion (SCC) during the study period.
Measured: Up to Week 72
Treatment Success Rate at Week 72
Proportion of participants achieving treatment success at Week 72, based on predefined criteria.
Measured: Week 72
Sputum Culture Conversion Rates at Multiple Time Points
Proportion of participants achieving sputum culture conversion at Weeks 8, 12, 16, 20, 36, 48, 60, and 72.
Measured: Up to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start2 Sep 2022
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rifampin-Resistant Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into two groups (Sudapyridine and Bedaquiline) for parallel treatment evaluation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naihui Chu, Ph.D, Principal investigator, Beijing Chest Hospital affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824871
- Sponsor's protocol ID
- JYP0081M301
- Acronym
- WISH
- Status last verified
- Nov 2024
- First submitted
- 10 Apr 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05824871
- Acronym / sponsor ID
- WISH / JYP0081M301
- Keywords
- Rifampin-Resistant Tuberculosis, Multidrug-Resistant Tuberculosis (MDR-TB), Pulmonary Tuberculosis, Sudapyridine (WX-081), Bedaquiline, Antitubercular Agents, Randomized Controlled Trial, Background Regimen Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Oct 2026 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This Phase III clinical study is designed to evaluate the efficacy and safety of Sudapyridine (WX-081) in combination with a background regimen (BR) for the treatment of rifampicin-resistant pulmonary tuberculosis. The study will be conducted at multiple centers, employing a randomized, double-blind, active-controlled design.
The study will consist of three phases:
Screening Phase:
Duration: Up to 2 weeks. Approximately 450 participants with rifampicin-resistant pulmonary tuberculosis will be screened for eligibility.
Treatment Phase:
Participants will be randomized in a 2:1 ratio into two groups:
- Sudapyridine Group: Sudapyridine (WX-081) with placebo and BR.
- Bedaquiline Group: Bedaquiline with placebo and BR. Treatment duration: 24 weeks.
Background Regimen Phase:
After completing the treatment phase, participants in both groups will continue to receive the background regimen (BR) until Week 72.
The study aims to test the hypothesis that Sudapyridine (WX-081), when combined with a background regimen, is effective and safe for treating rifampicin-resistant pulmonary tuberculosis. The data collected from this study will include primary and secondary endpoints related to efficacy and safety, PK/PD data, and cardiac safety evaluations.
The sample size of approximately 450 participants is designed to provide adequate power to detect a statistically significant difference in outcomes between treatment groups. Comprehensive data validation procedures and a robust statistical analysis plan will ensure the reliability and accuracy of the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into two groups (Sudapyridine and Bedaquiline) for parallel treatment evaluation.
| Arm | Type | Receives |
|---|---|---|
| Sudapyridine (WX-081) Group | Experimental | Drug: SudapyridineParticipants 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. |
| Bedaquiline Group | Active comparator | Drug: BedaquilineParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg/m2, and 40kg≤ body weight ≤90kg;
Key exclusion criteria (12 listed)
- • Allergic to any study drug or its ingredients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SudapyridineAlso: WX-081Sudapyridine (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. | Drug | Sudapyridine (WX-081) Group |
| BedaquilineBedaquiline 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. | Drug | Bedaquiline Group |
Primary outcome
Sputum Culture Conversion Rate at Week 24
Time frame: Week 24
Proportion of participants achieving sputum culture conversion (SCC) at Week 24 of treatment, measured as a percentage.
3 secondary outcomes
Time to Sputum Culture Conversion
Time frame: Up to Week 72
Treatment Success Rate at Week 72
Time frame: Week 72
Sputum Culture Conversion Rates at Multiple Time Points
Time frame: Up to Week 72
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naihui Chu, Ph.D principal investigator
Beijing Chest Hospital affiliated to Capital Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sudapyridine and Bedaquiline in people with Rifampin-Resistant Pulmonary Tuberculosis and Tuberculosis, Multidrug-Resistant (MDR-TB), run by Shanghai Jiatan Pharmatech Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naihui Chu, MD (010-89509312, dongchu1994@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum Culture Conversion Rate at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.