A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis

Recruiting now · Phase 3

Conditions studied: Pulmonary Tuberculosis

In brief

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.

Key facts

Study ID

NCT07209761

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

532

Starts

2025-10-16

Expected to finish

2028-09-29

Last updated by the study team

2026-05-06

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Capital Medical University - Beijing Chest Hospital — Beijing, Beijing Municipality, China (enrolling)
• National Center for Tuberculosis and Lung Disease — Tbilisi, Georgia (enrolling)
• IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology — Chisinau, Chisinau City, Moldova (enrolling)
• Silang Specialist Medical Center — Silang, Cavite, Philippines (enrolling)
• Tropical Disease Foundation — Makati City, National Capital Region, Philippines (enrolling)
• Synergy Biomed Research Institute — East London, Eastern Cape, South Africa (enrolling)
• Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital — Port Elizabeth, Eastern Cape, South Africa (enrolling)
• The Aurum Institute - Tembisa Hospital Clinical Research Centre — Johannesburg, Gauteng, South Africa (enrolling)
• Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital — Johannesburg, Gauteng, South Africa (enrolling)
• Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital, — Johannesburg, Gauteng, South Africa (enrolling)
• Centre for the AIDS Programme of Research in South Africa (CAPRISA) — Durban, KwaZulu-Natal, South Africa (enrolling)
• Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit — Klerksdorp, North West, South Africa (enrolling)
• UCT Lung Institute — Cape Town, Western Cape, South Africa (enrolling)
• Centro de Investigación del Hospital de Emergencias de Villa el Salvador — Villa El Salvador, Lima region, Peru
• Hospital Sergio E. Bernales — Lima, Peru
• Perinatal HIV Research Unit (PHRU) - Chris Hani Baragwanath Academic Hospital — Soweto, Gauteng, South Africa
• Jose B. Lingad Memorial Regional Hospital — San Fernando City, Central Luzon (Region III), Philippines
• The Catholic University of Korea, Incheon St. Mary's Hospital — Incheon, Incheon Metropolitan City, South Korea
• Lung Center Of The Philippines — Quezon City, National Capital Region, Philippines
• Pusan National University Hospital — Busan, Pusan-Kwangyokshi, South Korea
• The Aurum Institute - Rustenburg — Rustenburg, North West, South Africa
• Brooklyn Chest Hospital — Belville, Western Cape, South Africa
• UCT - Lung Infection and Immunity Unit — Cape Town, Western Cape, South Africa
• Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province — Fuzhou, Fujian, China
• The Third People's Hospital of Shenzhen — Shenzhen, Guangdong, China

Full record on ClinicalTrials.gov

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