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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

A Study of Quabodepistat-containing Regimen for the Treatment of Drug-resistant Pulmonary Tuberculosis (QUANTUM-TB).

Sanada Nobuhito

Otsuka Pharmaceutical Co., LTD.

2-16-4 Konan,Minato-ku,Tokyo ,Japan

OPC_32320100013_jp@otsuka.jp

Drug Information Center

Otsuka Pharmaceutical Co., LTD.

2-16-4, Konan, Minato-ku, Tokyo, Japan

+81-3-6361-7314

opc_ctr@otsuka.jp

Recruiting

June. 01, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Age >=14 years
2. Body weight >=30.0 kg
3. Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
4. Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
5. Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
6. Chest radiograph consistent with active TB disease
7. Able to provide sputum sample
8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
9. Willing to have HIV test (unless previous positive result confirmed)
10. 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/uL

1. Known/suspected resistance to BDQ, PMD, LZD, or QBS
2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for >=1 month within past 3 months
3. Severe extrapulmonary TB
4. Abnormal laboratory values: ALT/AST >2.5xULN, Total bilirubin >1.5xULN,
eGFR <60 mL/min/1.73m2, Hemoglobin <8 g/dL, Platelets <100,000 cells/mm3,
WBC <2.0x10^9/L, ANC <1000 cells/uL, and HbA1c >9.0%
5. Pre-existing peripheral neuropathy (>=Grade 1), optic neuritis, or visual impairment
6. Co-enrollment in other therapeutic trials
7. QTcF >450 msec (males) or >470 msec (females)
8. Clinically significant cardiovascular disorders
9. Bleeding disorders
10. Conditions interfering with X-ray or sputum assessment
11. Drug allergies/hypersensitivity to study medications
12. Pregnancy or breastfeeding
13. Positive drug screen (case-by-case assessment for some substances)
14. Serious mental disorders
15. Karnofsky score <60
16. BMI <16.0 kg/m2
17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
18. Pulmonary conditions other than TB (silicosis, fibrosis)
19. Active SARS-CoV-2 infection
20. Use of prohibited medications
21. Blood/plasma donation within 30 days
22. Current use of herbal remedies or traditional medicines

Both

Pulmonary Multidrug-resistant Tuberculosis

Drug: BPaQM
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

Drug: BPaLM
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

Drug: BPaQ
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

Drug: BPaL
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

1. 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).
[Time Frame: From randomization to Month 12]

2. Incidence of Grade >=3 Treatment-Emergent Adverse Events (TEAE),
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.
[Time Frame: From first dose to 2 weeks after end of treatment
(Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)]

+81-42-491-4111

Mar. 23, 2026

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. Supporting Materials: Study Protocol and Statistical Analysis Plan (SAP) 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. Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

China/Georgia/Moldova/Peru/Philippines/South Africa/South Korea