Pulmonary TuberculosisPhase 3QUANTUM-TBNCT07209761
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
A Phase 3 study testing BPaQM, BPaLM and BPaQ in people with Pulmonary Tuberculosis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 35 sites in 8 countries.
Trial summary
This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- BPaQM, BPaLM and BPaQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 35 sitesin 8 countries
- Study dates
- 16 Oct 2025to 29 Sep 2028
- Phase
- Phase 3
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥14 years
- Body weight ≥30.0 kg
- Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
- Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
- Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
- Chest radiograph consistent with active TB disease
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- Able to provide sputum sample
- Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
- Willing to have HIV test (unless previous positive result confirmed)
- For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load <200 copies/mL, and CD4 count >100 cells/mL
Who cannot join
- Known/suspected resistance to BDQ, PMD, LZD, or QBS
- Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
- Severe extrapulmonary TB
- Abnormal laboratory values: ALT/AST >2.5×ULN, Total bilirubin >1.5×ULN, eGFR <60 mL/min/1.73m², Hemoglobin <8 g/dL, Platelets <100,000 cells/mm³, WBC <2.0×10⁹/L, ANC <1000 cells/μL, and HbA1c >9.0%
- Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
- Co-enrollment in other therapeutic trials
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- QTcF >450 msec (males) or >470 msec (females)
- Clinically significant cardiovascular disorders
- Bleeding disorders
- Conditions interfering with X-ray or sputum assessment
- Drug allergies/hypersensitivity to study medications
- Pregnancy or breastfeeding
- Positive drug screen (case-by-case assessment for some substances)
- Serious mental disorders
- Karnofsky score <60
- BMI <16.0 kg/m²
- Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
- Pulmonary conditions other than TB (silicosis, fibrosis)
- Active SARS-CoV-2 infection
- Use of prohibited medications
- Blood/plasma donation within 30 days
- Current use of herbal remedies or traditional medicines
Trial locations and contacts
35 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 8 countries
South Africa13 sites, 13 recruiting
- Not yet recruiting
Brooklyn Chest Hospital
Belville, Western Cape, 7405
- Not yet recruiting
UCT - Lung Infection and Immunity Unit
Cape Town, Western Cape, 7700
- Recruiting
UCT Lung Institute
Cape Town, Western Cape, 7700
- Recruiting
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Durban, KwaZulu-Natal, 4013
- Recruiting
Synergy Biomed Research Institute
East London, Eastern Cape, 5241
- Recruiting
The Aurum Institute - Tembisa Hospital Clinical Research Centre
Johannesburg, Gauteng, 1632
- Recruiting
Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital
Johannesburg, Gauteng, 2092
- Recruiting
Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital,
Johannesburg, Gauteng, 2131
- Recruiting
Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit
Klerksdorp, North West, 2574
- Recruiting
Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital
Port Elizabeth, Eastern Cape, 6003
- Not yet recruiting
Setshaba Research Center
Pretoria, Gauteng, 0152
- Not yet recruiting
The Aurum Institute - Rustenburg
Rustenburg, North West, 0299
- Not yet recruiting
Perinatal HIV Research Unit (PHRU) - Chris Hani Baragwanath Academic Hospital
Soweto, Gauteng, 1835
China9 sites, 9 recruiting
- Recruiting
Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, 101100
- Not yet recruiting
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, 610041
- Not yet recruiting
Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province
Fuzhou, Fujian, 350008
- Not yet recruiting
Shandong Public Health Clinical Center
Jinan, Shandong, 250102
- Not yet recruiting
The Second Hospital of Nanjing
Nanjing, Jiangsu, 210003
- Not yet recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
- Not yet recruiting
Shanghai Pulmonary Hospital - Pneumology
Shanghai, Shanghai Municipality, 200433
- Not yet recruiting
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, 518112
- Not yet recruiting
Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)
Wuhan, Hubei, 430032
Philippines4 sites, 4 recruiting
- Recruiting
Tropical Disease Foundation
Makati City, National Capital Region, 1772
- Not yet recruiting
Lung Center Of The Philippines
Quezon City, National Capital Region, 1100
- Not yet recruiting
Jose B. Lingad Memorial Regional Hospital
San Fernando City, Central Luzon (Region III), 2000
- Recruiting
Silang Specialist Medical Center
Silang, Cavite, 4118
Peru3 sites, 3 recruiting
- Not yet recruiting
Socios en Salud Sucursal Peru
La Molina, Lima region, 15012
- Not yet recruiting
Hospital Sergio E. Bernales
Lima, 15313
- Not yet recruiting
Centro de Investigación del Hospital de Emergencias de Villa el Salvador
Villa El Salvador, Lima region, 15837
South Korea3 sites, 3 recruiting
- Not yet recruiting
Pusan National University Hospital
Busan, Pusan-Kwangyokshi, 49241
- Not yet recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, Incheon Metropolitan City, 21431
- Not yet recruiting
Asan Medical Center - Pulmonology
Seoul, Seoul Teugbyeolsi, 05505
Georgia1 site, 1 recruiting
- Recruiting
National Center for Tuberculosis and Lung Disease
Tbilisi, 0101
Japan1 site, 1 recruiting
- Not yet recruiting
Japan Anti-Tuberculosis Association Fukujuji Hospital
Kiyose, Tokyo, 204-8522
Moldova1 site, 1 recruiting
- Recruiting
IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology
Chisinau, Chisinau City, MD-2025
About this study
Official title: A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis
This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.
Read the detailed description
This is a Phase 3, randomized, open-label, multicenter trial evaluating quabodepistat-containing regimens for rifampicin-resistant/multidrug-resistant (RR/MDR) pulmonary tuberculosis (TB).
The study aims to enroll 532 participants aged 14 years and older.
The study has two main cohorts:
Fluoroquinolone-sensitive RR/MDR-TB (432 participants):
- Experimental arm: BPaQM (bedaquiline, pretomanid, quabodepistat, moxifloxacin) for 4 months
- Control arm: BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) for 6 months
Fluoroquinolone-resistant RR/MDR-TB (100 participants):
- Experimental arm: BPaQ (bedaquiline, pretomanid, quabodepistat) for 6 months
- Control arm: BPaL (bedaquiline, pretomanid, linezolid) for 6 months
The primary efficacy endpoint is an unfavorable outcome by 12 months post-randomization.
Secondary endpoints include time to unfavorable outcome, time to sputum culture conversion, and safety/tolerability assessments. Participants will be followed for 16 months post-randomization.
The study will be conducted at approximately 40 sites in up to 12 countries.
An independent Data Monitoring Committee and Endpoint Adjudication Committee will be used in the study.
The trial aims to evaluate if quabodepistat-containing regimens can shorten treatment duration to 4 months for fluoroquinolone-sensitive RR/MDR-TB and provide a safer alternative to linezolid-containing regimens for both fluoroquinolone-sensitive and fluoroquinolone-resistant RR/MDR-TB.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- BPaQM, BPaLM, BPaQ, BPaL
- Keywords
- Pulmonary Tuberculosis, Quabodepistat, Bedaquiline, Pretomanid, Linezolid, Moxifloxacin, Fluoroquinolone-sensitive TB, Fluoroquinolone-resistant TB, Drug-resistant TB, Shortened TB treatment
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPaQMDrug
Also called Bedaquiline, Pretomanid, Quabodepistat, Moxifloxacin
Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin 400 mg once daily for 17 weeks
BPaLMDrug
Also called Bedaquiline, Pretomanid, Linezolid, Moxifloxacin
Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks + Moxifloxacin 400 mg once daily for 26 weeks
BPaQDrug
Also called Bedaquiline, Pretomanid, Quabodepistat
Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Quabodepistat 30 mg once daily for 26 weeks
BPaLDrug
Also called Bedaquiline, Pretomanid, Linezolid
Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| BPaQM for Fluoroquinolone-sensitive RR/MDR-TB | Experimental | Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin 400 mg once daily for 17 weeks Receives: Drug: BPaQM |
| BPaLM for Fluoroquinolone-sensitive RR/MDR-TB | Active comparator | Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks + Moxifloxacin 400 mg once daily for 26 weeks Receives: Drug: BPaLM |
| BPaQ for Fluoroquinolone-resistant RR/MDR-TB | Experimental | Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Quabodepistat 30 mg once daily for 26 weeks Receives: Drug: BPaQ |
| BPaL for Fluoroquinolone-resistant RR/MDR-TB | Active comparator | Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks Receives: Drug: BPaL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with unfavorable outcome.
Unfavorable outcome is defined as a participant experiencing at least one of the following: death, treatment failure, change in regimen, or sputum culture with growth of Mycobacterium tuberculosis at certain timepoints as follows: Failure to achieve SCC at the end of the treatment period that results in a change in anti-mycobacterial therapy or Relapse during the follow-up period (i.e., the period from end of treatment to Month 12 post-randomization.
Measured: From randomization to Month 12
Incidence of Grade ≥3 Treatment-Emergent Adverse Events, Serious Adverse Events, or Adverse Events Leading to Dose Reduction or Discontinuation (Safety and Tolerability).
A participant experiencing at least one of the following: Grade 3 toxicity or higher treatment-emergent adverse events (TEAEs), serious TEAEs, or TEAEs leading to dose reduction or discontinuation.
Measured: From first dose to 2 weeks after end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)
Secondary outcomes (10)
Time to first occurrence of any event meeting the unfavorable outcome definition.
Time to the first occurrence of any event listed under the primary efficacy endpoint.
Measured: From randomization to Month 12
Time to sputum culture conversion.
Time from randomization to the first of two consecutive negative sputum cultures taken at least 1 week apart.
Measured: From randomization to end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)
Proportion of participants with sputum culture conversion.
Proportion of participants achieving sputum culture conversion, defined as two consecutive negative cultures taken at least 1 week apart.
Measured: At Week 8 and at end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)
Proportion of participants with microbiological relapse.
Proportion of microbiological relapse.
Measured: From end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL) to Month 12 post-randomization
Proportion of participants with adverse events of special interest (AESIs).
AESIs include QTc interval prolongation, hepatotoxicity, peripheral neuropathy, optic neuritis, and hematological toxicity.
Measured: From first dose to 2 weeks after end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)
Proportion of participants with treatment-emergent adverse events (TEAEs).
Proportion of participants with TEAEs, Grade 3 or higher TEAEs, and serious TEAEs.
Measured: From randomization through Week 68
Proportion of time during treatment spent without adverse events.
Measure of difference in AE-free time during treatment between experimental and standard of care arms.
Measured: From randomization to end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)
Proportion of participants who are lost to follow-up.
Measure of participant retention throughout the study period.
Measured: From randomization through Week 68
Proportion of participants with TB-related death.
Mortality specifically related to tuberculosis.
Measured: From randomization through Week 68
Plasma concentrations of each analyte at scheduled visits.
Plasma concentrations of trial drugs in experimental arms.
Measured: From randomization through Week 17 (BPaQM and BPaQ only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start16 Oct 2025
- Primary completion28 May 2027 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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
- The study has two parallel cohorts based on fluoroquinolone sensitivity status, each with an experimental arm and a control arm.
- Masking
- None (open label)
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simbarashe G Takuva, MD, MSc., Study director, Study Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209761
- Sponsor's protocol ID
- 323-201-00013
- Other IDs
- jRCT2031260045
- Acronym
- QUANTUM-TB
- Status last verified
- May 2026
- First submitted
- 12 Aug 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.