Actively Recruiting
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-05-06
532
Participants Needed
35
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older
- Body weight of at least 30.0 kg
- Able to provide written informed consent, or assent with parent/guardian consent if under 18
- Confirmed pulmonary tuberculosis with rifampicin resistance by Xpert MTB/RIF Ultra test
- Chest X-ray showing active tuberculosis
- Able to provide a sputum sample
- Participants of childbearing potential agree to use two approved birth control methods during treatment and for 12 weeks after last dose
- Willingness to have an HIV test unless previously confirmed positive
- For HIV-positive participants: stable antiretroviral therapy for at least 3 months, viral load under 200 copies/mL, and CD4 count above 100 cells/mL
You will not qualify if you...
- Known or suspected resistance to bedaquiline, pretomanid, linezolid, or quabodepistat
- Prior treatment with bedaquiline, pretomanid, linezolid, delamanid, quabodepistat, or DprE1 inhibitors for at least 1 month within the past 3 months
- Severe extrapulmonary tuberculosis
- Abnormal lab tests including ALT/AST greater than 2.5 times upper limit of normal, total bilirubin over 1.5 times upper limit, eGFR under 60 mL/min/1.73m², hemoglobin under 8 g/dL, platelets under 100,000/mm³, white blood cells under 2.0 ×10⁹/L, neutrophils under 1000 cells/μL, or HbA1c over 9.0%
- Peripheral neuropathy grade 1 or higher, optic neuritis, or visual impairment
- Participating in other therapeutic clinical trials
- QTcF over 450 msec for males or over 470 msec for females
- Significant cardiovascular disorders
- Bleeding disorders
- Conditions that interfere with chest X-ray or sputum assessment
- Allergies or hypersensitivity to study medications
- Pregnancy or breastfeeding
- Positive drug screen (evaluated individually for some substances)
- Serious mental disorders
- Karnofsky performance score below 60
- Body mass index under 16.0 kg/m²
- Significant other medical conditions such as metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine or liver diseases
- Pulmonary conditions other than tuberculosis like silicosis or fibrosis
- Active COVID-19 infection
- Use of prohibited medications
- Blood or plasma donation within 30 days
- Current use of herbal remedies or traditional medicines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101100
Actively Recruiting
2
Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province
Fuzhou, Fujian, China, 350008
Not Yet Recruiting
3
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518112
Not Yet Recruiting
4
Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)
Wuhan, Hubei, China, 430032
Not Yet Recruiting
5
The Second Hospital of Nanjing
Nanjing, Jiangsu, China, 210003
Not Yet Recruiting
6
Shandong Public Health Clinical Center
Jinan, Shandong, China, 250102
Not Yet Recruiting
7
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040
Not Yet Recruiting
8
Shanghai Pulmonary Hospital - Pneumology
Shanghai, Shanghai Municipality, China, 200433
Not Yet Recruiting
9
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
10
National Center for Tuberculosis and Lung Disease
Tbilisi, Georgia, 0101
Actively Recruiting
11
Japan Anti-Tuberculosis Association Fukujuji Hospital
Kiyose, Tokyo, Japan, 204-8522
Not Yet Recruiting
12
IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology
Chisinau, Chisinau City, Moldova, MD-2025
Actively Recruiting
13
Socios en Salud Sucursal Peru
La Molina, Lima region, Peru, 15012
Not Yet Recruiting
14
Centro de Investigación del Hospital de Emergencias de Villa el Salvador
Villa El Salvador, Lima region, Peru, 15837
Not Yet Recruiting
15
Hospital Sergio E. Bernales
Lima, Peru, 15313
Not Yet Recruiting
16
Silang Specialist Medical Center
Silang, Cavite, Philippines, 4118
Actively Recruiting
17
Jose B. Lingad Memorial Regional Hospital
San Fernando City, Central Luzon (Region III), Philippines, 2000
Not Yet Recruiting
18
Tropical Disease Foundation
Makati City, National Capital Region, Philippines, 1772
Actively Recruiting
19
Lung Center Of The Philippines
Quezon City, National Capital Region, Philippines, 1100
Not Yet Recruiting
20
Synergy Biomed Research Institute
East London, Eastern Cape, South Africa, 5241
Actively Recruiting
21
Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital
Port Elizabeth, Eastern Cape, South Africa, 6003
Actively Recruiting
22
The Aurum Institute - Tembisa Hospital Clinical Research Centre
Johannesburg, Gauteng, South Africa, 1632
Actively Recruiting
23
Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital
Johannesburg, Gauteng, South Africa, 2092
Actively Recruiting
24
Sizwe Clinical Research Site (CHRU) - Sizwe Tropical Disease Hospital,
Johannesburg, Gauteng, South Africa, 2131
Actively Recruiting
25
Setshaba Research Center
Pretoria, Gauteng, South Africa, 0152
Not Yet Recruiting
26
Perinatal HIV Research Unit (PHRU) - Chris Hani Baragwanath Academic Hospital
Soweto, Gauteng, South Africa, 1835
Not Yet Recruiting
27
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Durban, KwaZulu-Natal, South Africa, 4013
Actively Recruiting
28
Klerksdorp/Tshepong Hospital Complex, Tshepong Hospital, MDR Unit
Klerksdorp, North West, South Africa, 2574
Actively Recruiting
29
The Aurum Institute - Rustenburg
Rustenburg, North West, South Africa, 0299
Not Yet Recruiting
30
Brooklyn Chest Hospital
Belville, Western Cape, South Africa, 7405
Not Yet Recruiting
31
UCT - Lung Infection and Immunity Unit
Cape Town, Western Cape, South Africa, 7700
Not Yet Recruiting
32
UCT Lung Institute
Cape Town, Western Cape, South Africa, 7700
Actively Recruiting
33
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, Incheon Metropolitan City, South Korea, 21431
Not Yet Recruiting
34
Pusan National University Hospital
Busan, Pusan-Kwangyokshi, South Korea, 49241
Not Yet Recruiting
35
Asan Medical Center - Pulmonology
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Not Yet Recruiting
Research Team
O
Otsuka Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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