A Phase 3 interventional study of Bedaquiline and Quabodepistat in Rifampicin-Resistant Pulmonary Tuberculosis and Multidrug-Resistant Pulmonary Tuberculosis, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Recruiting at 42 sites in 10 countries. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment
…and 11 more changes, on the record history on ClinicalTrials.gov ↗
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or multidrug-resistant pulmonary tuberculosis.
Participants are assigned to 1 of 2 cohorts based on fluoroquinolone susceptibility. In the fluoroquinolone-susceptible cohort, participants are randomized 1:1 to receive either a 4-month experimental regimen of bedaquiline, pretomanid, quabodepistat, and moxifloxacin or a 6-month control regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. In the fluoroquinolone-resistant cohort, participants are randomized 3:1 to receive either a 6-month experimental regimen of bedaquiline, pretomanid, and quabodepistat or a 6-month control regimen of bedaquiline, pretomanid, and linezolid.
A total of approximately 532 participants are planned, including 432 participants in the fluoroquinolone-susceptible cohort and approximately 100 participants in the fluoroquinolone-resistant cohort. The primary efficacy endpoint is the proportion of participants with an unfavorable outcome by 12 months post-randomization. Prespecified agency-specific definitions are used for the classification of regimen changes, sputum culture conversion, relapse, and reinfection. All unfavorable outcome events will be confirmed by a blinded Endpoint Adjudication Committee.
This Phase 3, randomized, open-label, active-controlled, multicenter trial that evaluates quabodepistat as part of efficacious, shorter duration, less toxic and well tolerated regimens for participants with drug-resistant (DR) tuberculosis (TB).
Participants are assigned to one of two cohorts based on fluoroquinolone susceptibility determined using a rapid molecular test at screening. Approximately 432 participants with fluoroquinolone-susceptible tuberculosis are randomized in a 1:1 ratio to receive either the 4-month experimental BPaQM regimen or the 6-month active-control BPaLM regimen. Approximately 100 participants with fluoroquinolone-resistant tuberculosis are randomized in a 3:1 ratio to receive either the 6-month experimental BPaQ regimen or the 6-month active-control BPaL regimen. A total of approximately 532 participants are planned. Randomization is stratified by country and disease severity, which is based on chest radiograph findings and baseline bacterial burden.
Enrollment may be managed to maintain an appropriate distribution across disease-severity categories. Enrollment of participants living with HIV may be restricted in certain countries because of applicable regulatory or country-specific requirements.
If fluoroquinolone susceptibility results from the screening molecular test and phenotypic susceptibility testing of trial-entry specimens are discordant, all available microbiological and clinical information is considered. Discordant results are resolved using protocol-defined methods and World Health Organization guidance, and sequencing may be used to support the interpretation. A change in cohort or treatment regimen occurs only when supported by the available evidence and protocol-defined medical review.
Participants may be classified as late exclusions if cultures from trial-entry sputum fail to grow Mycobacterium tuberculosis, rifampicin resistance is not confirmed by Xpert MTB/RIF Ultra testing of the trial-entry isolate, or the trial-entry isolate is confirmed to be resistant to an allocated trial drug other than moxifloxacin. Participants classified as late exclusions discontinue trial treatment and are referred for appropriate treatment in accordance with the protocol.
The primary efficacy endpoint is the proportion of participants with an unfavorable outcome by 12 months after randomization. Prespecified definitions will be applied to the classification of regimen changes, sputum culture conversion, relapse, and reinfection. All unfavorable outcome events are reviewed by a blinded Endpoint Adjudication Committee.
Participants are followed through Week 68, approximately 16 months after randomization. A Week 72 contact or visit may be conducted for participants with ongoing adverse events or when additional follow-up is required for relapse, microbiological recurrence, or another protocol-defined assessment.
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's planned enrollment of 532 is above the median of 194 across 88 interventional studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 26, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bedaquiline 400 mg orally once daily for 2 weeks, followed by 100 mg orally once daily for 15 weeks; pretomanid 200 mg orally once daily; quabodepistat 30 mg orally once daily; and moxifloxacin 400 mg orally once daily. The planned regimen duration is 4 months, with a target of 120 treatment days.
Drug: Bedaquiline · Drug: Quabodepistat · Drug: Pretomanid · Drug: Moxifloxacin
Bedaquiline 400 mg orally once daily for 2 weeks, followed by 200 mg orally 3 times weekly for 24 weeks; pretomanid 200 mg orally once daily; linezolid 600 mg orally once daily; and moxifloxacin 400 mg orally once daily. The planned regimen duration is 6 months, with a target of 182 treatment days. Protocol-defined linezolid dose reduction, interruption, or discontinuation may be permitted for toxicity.
Drug: Bedaquiline · Drug: Pretomanid · Drug: Moxifloxacin · Drug: Linezolid
Bedaquiline 400 mg orally once daily for 2 weeks, followed by 100 mg orally once daily for 24 weeks; pretomanid 200 mg orally once daily; and quabodepistat 30 mg orally once daily. The planned regimen duration is 6 months, with a target of 180 treatment days.
Drug: Bedaquiline · Drug: Quabodepistat · Drug: Pretomanid
Bedaquiline 400 mg orally once daily for 2 weeks, followed by 200 mg orally 3 times weekly for 24 weeks; pretomanid 200 mg orally once daily; and linezolid 600 mg orally once daily. The planned regimen duration is 6 months, with a target of 182 treatment days. Protocol-defined linezolid dose reduction, interruption, or discontinuation may be permitted for toxicity.
Drug: Bedaquiline · Drug: Pretomanid · Drug: Linezolid
In the BPaQM and BPaQ experimental arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 100 mg once daily for 15 weeks in the BPaQM arm or 24 weeks in the BPaQ arm. In the BPaLM and BPaL control arms, bedaquiline is administered orally at 400 mg once daily for 2 weeks, followed by 200 mg 3 times weekly for 24 weeks.
Also known as: BDQ; B
Quabodepistat 30 mg administered orally once daily under fed conditions, during or immediately after a meal. Quabodepistat is administered for 4 months, with a target of 120 treatment days, in the BPaQM arm and for 6 months, with a target of 180 treatment days, in the BPaQ arm.
Also known as: OPC-167832; QBS; Q
Pretomanid 200 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM, BPaQ, and BPaL arms.
Also known as: PMD; Pa
Moxifloxacin 400 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM arm.
Also known as: MFX; M
Linezolid 600 mg administered orally once daily for 6 months in the BPaLM and BPaL arms. Protocol-defined dose reduction to 300 mg once daily, temporary interruption, or discontinuation may be permitted to manage significant toxicity after consultation with the medical monitor.
Also known as: LZD; L
Proportion of participants with an unfavorable outcome by 12 months post-randomization.
Percentage of participants with at least one unfavorable outcome by 12 months post-randomization. All definitions include all-cause death, treatment failure, and failure to achieve sputum culture conversion by end of treatment leading to antimycobacterial therapy change. FDA-aligned: also includes tolerability-driven regimen changes and microbiological recurrence (relapse or reinfection); conversion requires two negative cultures ≥28 days apart with subsequent culture negativity. EMA-aligned: excludes tolerability-driven regimen changes and reinfection; conversion requires two negative cultures ≥1 week apart without an intervening positive culture. Other-Regulator: includes tolerability-driven regimen changes, excludes reinfection, and applies the EMA conversion criterion. All events are confirmed by a blinded Endpoint Adjudication Committee. These are prespecified operational definitions of one primary efficacy endpoint, not co-primary endpoints.
Time frame: From randomization through 12 months post-randomization.
Proportion of participants with significant treatment-emergent adverse events (TEAEs) during treatment and through 2 weeks after treatment.
Percentage of participants experiencing at least one of the following during the treatment period and through two weeks after the end of treatment: 1. A Grade 3 or higher treatment-emergent adverse event. 2. A serious treatment-emergent adverse event. 3. A treatment-emergent adverse event leading to dose reduction. 4. A treatment-emergent adverse event leading to discontinuation of study intervention. Each participant will be counted once for the composite endpoint, regardless of the number or type of qualifying events experienced.
Time frame: From the first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Time to first unfavorable outcome.
Time from randomization to the first occurrence of an unfavorable outcome. The FDA-aligned, EMA-aligned, and Other-Regulator definitions will be evaluated separately using the applicable prespecified definition. All unfavorable outcome events will be confirmed by the blinded Endpoint Adjudication Committee.
Time frame: From randomization through 12 months post-randomization.
Time to sputum culture conversion.
Time from randomization to sputum culture conversion. The FDA-aligned definition requires the first of 2 consecutive negative sputum cultures collected at least 28 days apart, with subsequent culture negativity during treatment. The EMA-aligned and Other-Regulator definitions require the first of 2 consecutive negative sputum cultures collected at least 1 week apart, without an intervening positive culture. Each definition will be evaluated separately.
Time frame: From randomization through the end of treatment, up to approximately 28 weeks.
Proportion of participants with significant TEAEs related to quabodepistat or linezolid.
Percentage of participants experiencing at least one Grade 3 or higher treatment-emergent adverse event, serious treatment-emergent adverse event, treatment-emergent adverse event leading to dose reduction, or treatment-emergent adverse event leading to discontinuation that is assessed as related to quabodepistat or linezolid. Each participant will be counted once for the composite measure, regardless of the number or type of qualifying events.
Time frame: From first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Proportion of participants with adverse events of special interest.
Percentage of participants experiencing at least one protocol-defined adverse event of special interest during treatment or within 2 weeks after treatment. Adverse events of special interest include QT interval prolongation, hepatotoxicity, peripheral neuropathy, optic neuritis, and myelotoxicity. Myelotoxicity includes Grade 3 or higher anemia, neutropenia, or thrombocytopenia.
Time frame: From first dose through 2 weeks after the end of treatment, up to approximately 28 weeks.
Proportion of participants with treatment-emergent adverse events through Week 68.
Percentage of participants experiencing at least one treatment-emergent adverse event from the first dose of trial intervention through Week 68 post-randomization.
Time frame: From first dose through Week 68 post-randomization.
Proportion of participants with Grade 3 or higher or serious TEAEs through Week 68.
Percentage of participants experiencing at least one Grade 3 or higher treatment-emergent adverse event or serious treatment-emergent adverse event from the first dose of trial intervention through Week 68 post-randomization. Each participant will be counted once for the composite measure, regardless of the number or type of qualifying events.
Time frame: From first dose through Week 68 post-randomization.
Proportion of treatment time without adverse events.
Proportion of each participant's assigned treatment period during which the participant is free from adverse events. Results will be summarized by treatment arm.
Time frame: During the assigned treatment period, approximately 4 or 6 months.
Proportion of participants lost to follow-up.
Percentage of participants who meet the protocol-defined criteria for lost to follow-up through Week 68 post-randomization.
Time frame: From randomization through Week 68.
Proportion of participants with tuberculosis-related death.
Percentage of participants who die from a cause adjudicated as related to tuberculosis through Week 68 post-randomization. Tuberculosis-related deaths will be confirmed by the blinded Endpoint Adjudication Committee.
Time frame: From randomization through Week 68.
Proportion of participants with sputum culture conversion at Week 8.
Percentage of participants who achieve sputum culture conversion by Week 8. Results will be derived separately using the prespecified FDA-aligned, EMA-aligned, and Other-Regulator sputum culture conversion definitions.
Time frame: At Week 8 post-randomization.
Proportion of participants with sputum culture conversion at end of treatment.
Percentage of participants who achieve sputum culture conversion by the end of the assigned treatment period. Results will be derived separately using the prespecified FDA-aligned, EMA-aligned, and Other-Regulator sputum culture conversion definitions.
Time frame: At the end of treatment, approximately 4 months for BPaQM and 6 months for BPaLM, BPaQ, and BPaL.
Proportion of participants with microbiological relapse by 12 months post-randomization.
Percentage of participants with microbiological recurrence during follow-up caused by the same Mycobacterium tuberculosis complex strain identified at baseline, as determined by whole-genome sequencing. Microbiological recurrence is based on protocol-defined positive cultures from separate specimens collected at least 1 week apart.
Time frame: From the end of treatment through 12 months post-randomization.
Proportion of participants with reinfection by 12 months post-randomization.
Percentage of participants with microbiological recurrence during follow-up caused by a Mycobacterium tuberculosis complex strain different from the strain identified at baseline, as determined by whole-genome sequencing. Microbiological recurrence is based on protocol-defined positive cultures from separate specimens collected at least 1 week apart.
Time frame: From the end of treatment through 12 months post-randomization.
Plasma concentrations of study drugs in quabodepistat-containing regimens.
Plasma concentrations of quabodepistat, pretomanid, bedaquiline, the bedaquiline M2 metabolite, and moxifloxacin at protocol-specified sampling visits in participants assigned to the BPaQM or BPaQ experimental arms. Moxifloxacin concentrations will apply only to participants assigned to BPaQM.
Time frame: During treatment at protocol-specified pharmacokinetic sampling visits, through approximately Week 15.
Proportion of participants with microbiological relapse at 10 months after treatment completion.
Percentage of participants with microbiological recurrence caused by the same Mycobacterium tuberculosis complex strain identified at baseline, as determined by whole-genome sequencing, by 10 months after completion of the assigned treatment regimen. Microbiological recurrence is based on protocol-defined positive cultures from separate specimens collected at least 1 week apart.
Time frame: From the end of treatment through 10 months after treatment completion.
Proportion of participants with microbiological relapse at Month 16.
Percentage of participants with microbiological recurrence caused by the same Mycobacterium tuberculosis complex strain identified at baseline, as determined by whole-genome sequencing, by Month 16 post-randomization. Microbiological recurrence is based on protocol-defined positive cultures from separate specimens collected at least 1 week apart.
Time frame: From the end of treatment through Month 16 post-randomization.
Proportion of participants with reinfection at 10 months after treatment completion.
Percentage of participants with microbiological recurrence caused by a Mycobacterium tuberculosis complex strain different from the strain identified at baseline, as determined by whole-genome sequencing, by 10 months after completion of the assigned treatment regimen.
Time frame: From the end of treatment through 10 months after treatment completion.
Proportion of participants with reinfection at Month 16.
Percentage of participants with microbiological recurrence caused by a Mycobacterium tuberculosis complex strain different from the strain identified at baseline, as determined by whole-genome sequencing, by Month 16 post-randomization.
Time frame: From the end of treatment through Month 16 post-randomization.
Proportion of participants with an unfavorable outcome at 10 months after treatment completion.
Percentage of participants with at least one unfavorable outcome by 10 months after completion of the assigned treatment regimen. Results will be derived separately using the prespecified FDA-aligned, EMA-aligned, and Other-Regulator definitions. All unfavorable outcome events will be confirmed by the blinded Endpoint Adjudication Committee.
Time frame: From randomization through 10 months after treatment completion.
Proportion of participants with an unfavorable outcome at Month 16.
Percentage of participants with at least one unfavorable outcome by Month 16 post-randomization. Results will be derived separately using the prespecified FDA-aligned, EMA-aligned, and Other-Regulator definitions. All unfavorable outcome events will be confirmed by the blinded Endpoint Adjudication Committee.
Time frame: From randomization through Month 16 post-randomization.
Proportion of participants with baseline resistance to anti-tuberculosis drugs.
Percentage of participants with phenotypically observed and/or genotypically predicted resistance to one or more anti-tuberculosis drugs at baseline. Results will be based on participants with evaluable baseline isolates and protocol-defined phenotypic or genotypic resistance assessments.
Time frame: At baseline.
Proportion of participants with acquired resistance to anti-tuberculosis drugs.
Percentage of participants who develop new phenotypically observed and/or genotypically predicted resistance to one or more anti-tuberculosis drugs after baseline. Results will be based on participants with evaluable baseline and post-baseline isolates.
Time frame: From baseline through Month 16 post-randomization.
Proportion of participants with cross-resistance to quabodepistat.
Percentage of participants with phenotypically observed and/or genotypically predicted cross-resistance to quabodepistat at baseline or acquired during the trial. Baseline and treatment-emergent cross-resistance will be summarized separately where data permit.
Time frame: At baseline and through Month 16 post-randomization.
Change from baseline in SF-36v2 Physical Component Summary score.
Change from baseline in the 36-Item Short-Form Health Survey Version 2 Physical Component Summary score at the end of treatment and Week 52. The SF-36v2 uses norm-based scoring, with higher scores indicating better physical health-related quality of life. The assessment will be performed when a validated questionnaire is available in the applicable language.
Time frame: From baseline through end of treatment and Week 52 post-randomization.
Change from baseline in SF-36v2 Mental Component Summary score.
Change from baseline in the 36-Item Short-Form Health Survey Version 2 Mental Component Summary score at the end of treatment and Week 52. The SF-36v2 uses norm-based scoring, with higher scores indicating better mental health-related quality of life. The assessment will be performed when a validated questionnaire is available in the applicable language.
Time frame: From baseline through end of treatment and Week 52 post-randomization.
Change from baseline in SF-6D health utility score.
Change from baseline in the Short-Form-6 Dimension health utility score at the end of treatment and Week 52. Scores range from 0.0 to 1.0, with higher scores indicating a better measured health state. The SF-6D score is derived from applicable SF-36v2 responses.
Time frame: From baseline through end of treatment and Week 52 post-randomization.
Change from baseline in St George's Respiratory Questionnaire scores.
Change from baseline in the St George's Respiratory Questionnaire total, Symptoms, Activity, and Impacts scores at the end of treatment and Week 52. Scores range from 0 to 100, with lower scores indicating better respiratory health-related quality of life. The assessment will be performed when a validated questionnaire is available in the applicable language.
Time frame: From baseline through end of treatment and Week 52 post-randomization.
Change from baseline in Chronic Airways Assessment Test scores.
Change from baseline in the Chronic Airways Assessment Test total score, symptom-burden item score, and daily-impacts item score at the end of treatment and Week 52. The questionnaire contains 8 items scored from 0 to 5, with higher scores indicating greater disease impact. The assessment will be performed when a validated questionnaire is available in the applicable language.
Time frame: From baseline through end of treatment and Week 52 post-randomization.
Participant-reported adverse-event frequency, severity, and interference.
Descriptive summaries over time of participant-reported adverse-event frequency, severity, and interference using selected items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. The questionnaire uses a 7-day recall period and will be administered when a validated version is available in the applicable language.
Time frame: From baseline through Week 68 post-randomization.
Percentage adherence to assigned trial intervention.
Percentage of protocol-required doses of the assigned trial intervention taken during the treatment period, based on protocol-defined adherence-monitoring methods. Adherence will be summarized by treatment arm.
Time frame: During the assigned treatment period, approximately 4 or 6 months.
Change from baseline in forced expiratory volume in 1 second.
Change from baseline in forced expiratory volume in 1 second, measured by spirometry, during treatment and follow-up. Results will be summarized by treatment arm and protocol-specified assessment visit.
Time frame: From baseline through Week 68 post-randomization.
Change from baseline in forced vital capacity.
Change from baseline in forced vital capacity, measured by spirometry, during treatment and follow-up. Results will be summarized by treatment arm and protocol-specified assessment visit.
Time frame: From baseline through Week 68 post-randomization.
Change from baseline in 18F-FDG PET-CT imaging measures.
Longitudinal change from baseline in protocol-defined 18F-fluorodeoxyglucose positron emission tomography-computed tomography imaging measures during treatment and follow-up. Assessments are limited to consenting participants aged 18 years or older enrolled at selected sites.
Time frame: From baseline through Week 52 post-randomization.
Change from baseline in creatinine-cystatin C-based estimated glomerular filtration rate.
Longitudinal change from baseline in estimated glomerular filtration rate calculated using combined serum creatinine and cystatin C measurements during treatment and follow-up. Results will be summarized by treatment arm and protocol-specified assessment visit.
Time frame: From baseline through Week 68 post-randomization.
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Plan to share: Yes — Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
Data sharing details ↗ · clinical-trials.otsuka.com
Started Oct 2025 (actual). Primary completion is estimated for Sep 2028, 35 months after the start.
Primary completion moved once since we started tracking on Sep 25, 2026: May 2027 → Sep 2028, on Oct 26, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
…and 11 more changes, on the record history on ClinicalTrials.gov ↗
…and 11 more changes, on the record history on ClinicalTrials.gov ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Quabodepistat · Moxifloxacin
Tuberculosis, Multidrug-Resistant →
Otsuka Pharmaceutical Development & Commercialization, Inc. →