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RECRUITING

NCT07209761

PHASE3

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

532

Start Date

2025-10-16

Completion Date

2028-09-29

Last Updated

2026-02-10

Healthy Volunteers

Conditions

Pulmonary Tuberculosis

Interventions

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

Inclusion Criteria: 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/mL Exclusion Criteria: 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 \>2.5×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% 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

Locations (33)

Capital Medical University - Beijing Chest Hospital

Beijing, Beijing Municipality, China

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)

Wuhan, Hubei, China

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Shanghai Pulmonary Hospital - Pneumology

Shanghai, Shanghai Municipality, China

Public Health Clinical Center of Chengdu

Chengdu, Sichuan, China

National Center for Tuberculosis and Lung Disease

Tbilisi, Georgia

Japan Anti-Tuberculosis Association Fukujuji Hospital

Kiyose, Tokyo, Japan

IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology

Chisinau, Chisinau City, Moldova

Socios en Salud Sucursal Peru

La Molina, Lima region, Peru

Centro de Investigación del Hospital de Emergencias de Villa el Salvador

Villa El Salvador, Lima region, Peru

Hospital Sergio E. Bernales

Lima, Peru

Silang Specialist Medical Center

Silang, Cavite, Philippines

Jose B. Lingad Memorial Regional Hospital

San Fernando City, Central Luzon (Region III), Philippines

Tropical Disease Foundation

Makati City, National Capital Region, Philippines

Lung Center Of The Philippines

Quezon City, National Capital Region, Philippines

Synergy Biomed Research Institute

East London, Eastern Cape, South Africa

Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital

Port Elizabeth, Eastern Cape, South Africa

The Aurum Institute - Tembisa Hospital Clinical Research Centre

Johannesburg, Gauteng, South Africa

Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital

Johannesburg, Gauteng, South Africa

Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital,

Johannesburg, Gauteng, South Africa

Setshaba Research Center

Pretoria, Gauteng, South Africa

Perinatal HIV Research Unit (PHRU) - Chris Hani Baragwanath Academic Hospital

Soweto, Gauteng, South Africa

Centre for the AIDS Programme of Research in South Africa (CAPRISA)

Durban, KwaZulu-Natal, South Africa

Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit

Klerksdorp, North West, South Africa

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

UCT Lung Institute

Cape Town, Western Cape, South Africa

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, Incheon Metropolitan City, South Korea

Pusan National University Hospital

Busan, Pusan-Kwangyokshi, South Korea

Seoul National University Hospital - Pulmonology

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center - Pulmonology

Seoul, Seoul Teugbyeolsi, South Korea

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (33)