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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 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

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Moxifloxacin

Moxifloxacin 400 mg administered orally once daily for 4 months in the BPaQM arm and for 6 months in the BPaLM arm.

DRUG

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