Pulmonary TuberculosisPhase 2WX-081NCT04608955
Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081
A Phase 2 study testing WX-081, Bedaquiline and Standard treatment in people with Pulmonary Tuberculosis, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.
Trial summary
This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with drug-naive\&susceptible and drug-resistant tuberculosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- WX-081, Bedaquiline and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2020to 13 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female, aged between 18 and 65 years.
- Body weight between 40 and 90 kg.
- Newly-treated drug sensitivity tuberculosis: clinically diagnosed as pulmonary tuberculosis, without treatment, sputum smear-positive for acid-fast bacilli (AFB at least 1+), and no resistant to rifampicin or isoniazid in the drug sensitivity test.
- Drug-resistant tuberculosis: re-treatment pulmonary tuberculosis patients, diagnosed as rifampicin resistance (RR-TB) or isoniazid and rifampicin resistance (MDR-TB) by molecular biology methods, and sputum smear-positive for acid-fast bacilli. Patients must be willing to discontinue all TB drugs to allow 7 days washout.
- Patients must consent to HIV-testing, or provide HIV-negative report within 6 months.
- Women are not breastfeeding or pregnant, and agree to practice effective contraception throughout the trial.
- Provide voluntary and written informed consent prior to all trial-related procedures, agree to comply with the requirements and restrictions listed in the informed consent form and agreement.
Who cannot join
- Patients with HIV infection.
- Patients with miliary tuberculosis or extrapulmonary tuberculosis judged by the investigator.
- Patients with certain QT/QTc interval characteristics as described in the protocol.
- the patients have a history of, or current evidence of clinically relevant unstable or severe cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, mental or rheumatic diseases, or any other condition that will not be suitable to participate in this study, according to the judgement of the investigator.
- Patients who have participated in other clinical studies within 8 weeks prior to trial start.
- Patients having a known or suspected hypersensitivity or serious adverse reaction to drugs used in this trial.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Current or past history of alcohol and/or drug use that, in the investigator's opinion, would compromise the participant's safety or compliance to the study protocol procedures.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 101149
About this study
Official title: A Multi-center, Randomized, Positive-controlled Phase 2 Clinical Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of WX-081 in Participants With Drug-naive&Susceptible or Drug-Resistant Pulmonary Tuberculosis
This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with drug-naive\&susceptible and drug-resistant tuberculosis. Also the efficacy of WX-081 will be explored in participants with drug-resistant tuberculosis.
Read the detailed description
This is a Phase 2, multi-center, randomized, parallel, open-label, positive-controlled clinical trial. The objective of this trial is to evaluate the early bactericidal activity, safety and tolerability of WX-081 patients with drug-naive\&susceptible and drug-resistant tuberculosis. and the efficacy in participants with drug-resistant tuberculosis.
This trial will be divided into core research stage (stage 1) and extended research stage (stage 2). During stage 1, a panel of 59 participants with drug-naive\&susceptible tuberculosis will be randomized to receive either WX-081(including 3 groups:150mg qd, 300mg qd, 450mg qd. n=12 per group) or standard treatment (n=8) for 2 weeks, and then followed by a follow-up period of 2 weeks. A panel of 40 participants with drug-resistant tuberculosis will be randomized to receive either WX-081 (400mg qd, n=20) or bedaquiline (400mg qd, n=20) for 2 weeks. During stage 2, the 40 participants with drug-resistant tuberculosis will receive WX-081(150mg qd) + MBT treatment (ie. multi-drug background treatment) and bedaquiline (200mg tiw) +MBT treatment for 6 weeks respectively, and then followed by a follow-up period of 4 weeks.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- WX-081, Bedaquiline, Standard treatment, Multi-drug background treatment (MBT)
- Keywords
- Tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WX-081Drug
WX-081 is not licensed yet. WX-081 will be used in arms A, B, C, WX-081+MBT.
BedaquilineDrug
This licensed drug will be used in arm F as positive comparator.
Standard treatment will be used in arm D as positive comparator, according to the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.
Multi-drug background treatment (MBT)Drug
MBT will be used in arm E, F as background treatment. The drugs used in MBT are all licensed drugs, and the treatment complies with the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: WX-081 | Experimental | Participants with newly-treated drug sensitivity tuberculosis receive WX-081 150mg orally once daily for 2 weeks. Receives: Drug: WX-081 |
| Arm B: WX-081 | Experimental | Participants with newly-treated drug sensitivity tuberculosis receive WX-081 300mg orally once daily for 2 weeks. Receives: Drug: WX-081 |
| Arm C: WX-081 | Experimental | Participants with newly-treated drug sensitivity tuberculosis receive WX-081 450mg orally once daily for 2 weeks. Receives: Drug: WX-081 |
| Arm D: Standard treatment | Active comparator | Participants with newly-treated drug sensitivity tuberculosis receive standard treatment for two weeks. Receives: Drug: Standard treatment |
| Arm E: WX-081+MBT | Experimental | Participants with drug-resistant tuberculosis receive WX-081 400mg orally once daily for 2 weeks, and then MBT+ WX-081 150mg orally once daily for 6 weeks. Receives: Drug: WX-081; Drug: Multi-drug background treatment (MBT) |
| Arm F: Bedaquiline+MBT | Active comparator | Participants with drug-resistant tuberculosis receive Bedaquiline 400mg orally once daily for 2 weeks, and then MBT+ Bedaquiline 200mg orally 3 times per week for 6 weeks. Receives: Drug: Bedaquiline; Drug: Multi-drug background treatment (MBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to positive (TTP)
TTP is measured as time to sputum culture positivity in Liquid Culture Media.
Measured: Day 0-14.
Early bactericidal activity (EBA) of WX-081
EBA is measured as the mean rate of colony forming unit (log10CFU) of mycobacterium tuberculosis per ml sputum on solid medium in different time periods.
Measured: Day 0-14.
Secondary outcomes (10)
change of electrocardiogram QT interval
QT interval is calculated as QTcF in milliseconds (ms)
Measured: Measured through 8 Weeks.
The percentage of participants with sputum culture-negative conversion.
Percentage of participants with an occurrence of sputum culture-negative through 8 weeks.
Measured: Measured through 8 Weeks.
Rate of change of colony forming units (CFU)
Rate of change of colony forming units (CFU) of mycobacterium tuberculosis on sputum culture through 8 weeks.
Measured: Measured through 8 Weeks.
The percentage of participants with sputum smear-negative conversion.
Percentage of participants with an occurrence of sputum smear-negative through 8 weeks.
Measured: Measured through 8 Weeks.
heart rate
heart rate in times per minute.
Measured: Measured through 8 Weeks.
blood pressure
blood pressure in mmHg
Measured: Measured through 8 Weeks.
Maximum plasma concentration (Cmax)
Blood samples will be taken at different time points before and after administration on Day1 and Day14 of treatment.
Measured: At day1 and 14.
Time to reach maximum plasma concentration (Tmax)
Blood samples will be taken at different time points before and after administration on Day1 and Day14 of treatment.
Measured: At day1 and 14.
Area under the plasma concentration versus time curve (AUC(0-t))
Blood samples will be taken at different time points before and after administration on Day1 and Day14 of treatment.
Measured: At day1 and 14.
Terminal plasma half-life (t1/2)
Blood samples will be taken at different time points before and after administration on Day1 and Day14 of treatment.
Measured: At day1 and 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start16 Oct 2020
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Song AiYun, MD, Study chair, Shang hai Jiatan Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608955
- Sponsor's protocol ID
- JYB0201
- Acronym
- WX-081
- Status last verified
- Sep 2023
- First submitted
- 10 Oct 2020
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Z, Luo W, Xu D, Guo F, Yang M, Zhu Y, Shen L, Chen S, Tang D, Li L, Li Y, Wang B, Franzblau SG, Ding CZ. Discovery and preclinical profile of sudapyridine (WX-081), a novel anti-tuberculosis agent. Bioorg Med Chem Lett. 2022 Sep 1;71:128824. doi: 10.1016/j.bmcl.2022.128824. Epub 2022 May 27.
PubMed 35636648
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Positive-controlled Phase 2 Clinical Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of WX-081 in Participants With Drug-naive&Susceptible or Drug-Resistant Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT04608955
- Acronym / sponsor ID
- WX-081 / JYB0201
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 30 Oct 2020 (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 multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with drug-naive\&susceptible and drug-resistant tuberculosis. Also the efficacy of WX-081 will be explored in participants with drug-resistant tuberculosis.
Detailed description
This is a Phase 2, multi-center, randomized, parallel, open-label, positive-controlled clinical trial. The objective of this trial is to evaluate the early bactericidal activity, safety and tolerability of WX-081 patients with drug-naive\&susceptible and drug-resistant tuberculosis. and the efficacy in participants with drug-resistant tuberculosis.
This trial will be divided into core research stage (stage 1) and extended research stage (stage 2). During stage 1, a panel of 59 participants with drug-naive\&susceptible tuberculosis will be randomized to receive either WX-081(including 3 groups:150mg qd, 300mg qd, 450mg qd. n=12 per group) or standard treatment (n=8) for 2 weeks, and then followed by a follow-up period of 2 weeks. A panel of 40 participants with drug-resistant tuberculosis will be randomized to receive either WX-081 (400mg qd, n=20) or bedaquiline (400mg qd, n=20) for 2 weeks. During stage 2, the 40 participants with drug-resistant tuberculosis will receive WX-081(150mg qd) + MBT treatment (ie. multi-drug background treatment) and bedaquiline (200mg tiw) +MBT treatment for 6 weeks respectively, and then followed by a follow-up period of 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Arm A: WX-081 | Experimental | Drug: WX-081Participants with newly-treated drug sensitivity tuberculosis receive WX-081 150mg orally once daily for 2 weeks. |
| Arm B: WX-081 | Experimental | Drug: WX-081Participants with newly-treated drug sensitivity tuberculosis receive WX-081 300mg orally once daily for 2 weeks. |
| Arm C: WX-081 | Experimental | Drug: WX-081Participants with newly-treated drug sensitivity tuberculosis receive WX-081 450mg orally once daily for 2 weeks. |
| Arm D: Standard treatment | Active comparator | Drug: Standard treatmentParticipants with newly-treated drug sensitivity tuberculosis receive standard treatment for two weeks. |
| Arm E: WX-081+MBT | Experimental | Drug: WX-081, Drug: Multi-drug background treatment (MBT)Participants with drug-resistant tuberculosis receive WX-081 400mg orally once daily for 2 weeks, and then MBT+ WX-081 150mg orally once daily for 6 weeks. |
| Arm F: Bedaquiline+MBT | Active comparator | Drug: Bedaquiline, Drug: Multi-drug background treatment (MBT)Participants with drug-resistant tuberculosis receive Bedaquiline 400mg orally once daily for 2 weeks, and then MBT+ Bedaquiline 200mg orally 3 times per week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged between 18 and 65 years.
- Body weight between 40 and 90 kg.
- Newly-treated drug sensitivity tuberculosis: clinically diagnosed as pulmonary tuberculosis, without treatment, sputum smear-positive for acid-fast bacilli (AFB at least 1+), and no resistant to rifampicin or isoniazid in the drug sensitivity test.
- Drug-resistant tuberculosis: re-treatment pulmonary tuberculosis patients, diagnosed as rifampicin resistance (RR-TB) or isoniazid and rifampicin resistance (MDR-TB) by molecular biology methods, and sputum smear-positive for acid-fast bacilli. Patients must be willing to discontinue all TB drugs to allow 7 days washout.
- Patients must consent to HIV-testing, or provide HIV-negative report within 6 months.
Key exclusion criteria (8 listed)
- Patients with HIV infection.
- Patients with miliary tuberculosis or extrapulmonary tuberculosis judged by the investigator.
- Patients with certain QT/QTc interval characteristics as described in the protocol.
- the patients have a history of, or current evidence of clinically relevant unstable or severe cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, mental or rheumatic diseases, or any other condition that will not be suitable to participate in this study, according to the judgement of the investigator.
- Patients who have participated in other clinical studies within 8 weeks prior to trial start.
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 |
|---|---|---|
| WX-081WX-081 is not licensed yet. WX-081 will be used in arms A, B, C, WX-081+MBT. | Drug | Arm A: WX-081, Arm B: WX-081, Arm C: WX-081, Arm E: WX-081+MBT |
| BedaquilineThis licensed drug will be used in arm F as positive comparator. | Drug | Arm F: Bedaquiline+MBT |
| Standard treatmentStandard treatment will be used in arm D as positive comparator, according to the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis. | Drug | Arm D: Standard treatment |
| Multi-drug background treatment (MBT)MBT will be used in arm E, F as background treatment. The drugs used in MBT are all licensed drugs, and the treatment complies with the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis. | Drug | Arm E: WX-081+MBT, Arm F: Bedaquiline+MBT |
Primary outcome
Time to positive (TTP)
Time frame: Day 0-14.
TTP is measured as time to sputum culture positivity in Liquid Culture Media.
Early bactericidal activity (EBA) of WX-081
Time frame: Day 0-14.
EBA is measured as the mean rate of colony forming unit (log10CFU) of mycobacterium tuberculosis per ml sputum on solid medium in different time periods.
10 secondary outcomes
change of electrocardiogram QT interval
Time frame: Measured through 8 Weeks.
The percentage of participants with sputum culture-negative conversion.
Time frame: Measured through 8 Weeks.
Rate of change of colony forming units (CFU)
Time frame: Measured through 8 Weeks.
The percentage of participants with sputum smear-negative conversion.
Time frame: Measured through 8 Weeks.
heart rate
Time frame: Measured through 8 Weeks.
blood pressure
Time frame: Measured through 8 Weeks.
Maximum plasma concentration (Cmax)
Time frame: At day1 and 14.
Time to reach maximum plasma concentration (Tmax)
Time frame: At day1 and 14.
Area under the plasma concentration versus time curve (AUC(0-t))
Time frame: At day1 and 14.
Terminal plasma half-life (t1/2)
Time frame: At day1 and 14.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 35636648Huang Z, Luo W, Xu D, Guo F, Yang M, Zhu Y, Shen L, Chen S, Tang D, Li L, Li Y, Wang B, Franzblau SG, Ding CZ. Discovery and preclinical profile of sudapyridine (WX-081), a novel anti-tuberculosis agent. Bioorg Med Chem Lett. 2022 Sep 1;71:128824. doi: 10.1016/j.bmcl.2022.128824. Epub 2022 May 27.
- 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. This study is not recruiting at the moment.
Song AiYun, MD study chair
Shang hai Jiatan Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WX-081, Bedaquiline and Standard treatment in people with Pulmonary Tuberculosis, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to positive (TTP) (time frame: Day 0-14.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608955, which also lists 1 linked publication.
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 11 Sep 2023.