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A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
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.
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
2026-10-26
Healthy Volunteers
No
Interventions
Bedaquiline
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.
Quabodepistat
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.
Pretomanid
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.
Moxifloxacin
Moxifloxacin 400 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM arm.
Linezolid
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.
Locations (42)
Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, China
Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province
Fuzhou, Fujian, 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
Shandong Public Health Clinical Center
Jinan, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 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
P.D. Hinduja Hospital & Medical Research Centre - MAHIM
Mumbai, Maharashtra, India
Rajan Babu Institute of Pulmonary Medicine and Tuberculosis (RBIPMT) - RBTB Hospital
New Delhi, National Capital Territory of Delhi, India
National Institute of Tuberculosis and Respiratory Diseases Hospital (NITRD)
New Delhi, National Capital Territory of Delhi, India
Indian Council of Medical Research (ICMR) - National Institute for Research in Tuberculosis (NIRT) (Tuberculosis Research Centre)
Chennai, Tamil Nadu, India
Jakarta Islamic Hospital - Rumah Sakit Islam Jakarta (RSIJ)
Jakarta, Special Capital Region of Jakarta, Indonesia
Rumah Sakit Umum Pusat (RSUP) Dr. Hasan Sadikin
Bandung, West Java, Indonesia
Rumah Sakit Paru Dr. M. Goenawan Partowidigdo (RSPG)
Bogor, West Java, Indonesia
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
Tropical Disease Foundation
Makati City, National Capital Region, Philippines
Lung Center Of The Philippines
Quezon City, National Capital Region, Philippines
Rafael Lazatin Memorial Medical Center
Angeles City, Pampanga, 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
Asan Medical Center - Pulmonology
Seoul, Seoul Teugbyeolsi, South Korea