Actively Recruiting
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
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-05-06
532
Participants Needed
35
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating quabodepistat-containing treatment regimens for adults and adolescents aged 14 years and older with rifampicin-resistant or multidrug-resistant pulmonary tuberculosis (RR/MDR-TB). The study aims to determine if adding quabodepistat to other TB drugs can shorten treatment duration to 4 months for fluoroquinolone-sensitive TB and provide a safer alternative compared to the current 6-month WHO-endorsed regimens. This Phase 3, randomized, open-label trial also compares treatments for patients with fluoroquinolone-resistant TB. Participants will be divided into two main groups based on fluoroquinolone sensitivity. Those with fluoroquinolone-sensitive RR/MDR-TB will receive either an experimental 4-month regimen (BPaQM: bedaquiline, pretomanid, quabodepistat, moxifloxacin) or a 6-month control regimen (BPaLM: bedaquiline, pretomanid, linezolid, moxifloxacin). Those with fluoroquinolone-resistant RR/MDR-TB will receive either an experimental 6-month regimen (BPaQ: bedaquiline, pretomanid, quabodepistat) or a control 6-month regimen (BPaL: bedaquiline, pretomanid, linezolid). Dosing schedules vary by regimen and last either 4 or 6 months. During the 16-month follow-up, participants will undergo regular assessments including sputum samples, chest X-rays, laboratory tests, and safety evaluations. Researchers will measure treatment effectiveness by the proportion with unfavorable outcomes 12 months after randomization and monitor adverse events. Additional outcomes include time to sputum culture conversion, microbiological relapse, and drug plasma levels. Safety will be closely monitored throughout treatment and follow-up periods.
CONDITIONS
Brief 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 (participant assent and parent/guardian consent if under 18)
- Documented pulmonary tuberculosis confirmed by Xpert MTB/RIF Ultra test with rifampicin resistance
- Chest X-ray consistent with active tuberculosis disease
- Able to provide sputum sample
- Participants of childbearing potential must use two approved birth control methods during treatment and for 12 weeks after last dose
- Willing to have HIV test unless previously confirmed positive
- For HIV-positive participants: on stable antiretroviral regimen for at least 3 months, viral load under 200 copies/mL, and CD4 count over 100 cells/mL
You will not qualify if you...
- Known or suspected resistance to bedaquiline, pretomanid, linezolid, delamanid, quabodepistat, or DprE1 inhibitors
- Prior treatment with bedaquiline, pretomanid, linezolid, delamanid, quabodepistat, or DprE1 inhibitors for 1 month or more within the past 3 months
- Severe extrapulmonary tuberculosis
- Abnormal lab values including ALT/AST over 2.5 times normal, total bilirubin over 1.5 times normal, low kidney function, low hemoglobin, low platelets, low white blood cells, low neutrophils, or high HbA1c over 9.0%
- Pre-existing peripheral neuropathy Grade 1 or higher, optic neuritis, or visual impairment
- Co-enrollment in other therapeutic trials
- Prolonged QT interval above 450 msec in males or 470 msec in females
- Significant cardiovascular disorders or bleeding disorders
- Conditions interfering with chest X-ray or sputum assessments
- Allergies or hypersensitivity to study medications
- Pregnancy or breastfeeding
- Positive drug screen (assessed case-by-case)
- Serious mental disorders
- Karnofsky score below 60
- Body mass index below 16.0 kg/m2
- Significant comorbidities including metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, or liver diseases
- Pulmonary conditions other than tuberculosis such as 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months or 6 months depending on assigned regimen
Participants receive one of several quabodepistat-containing or comparator drug regimens for rifampicin-resistant/multidrug-resistant pulmonary tuberculosis.
Visits scheduled according to treatment regimen over the treatment period
Duration - Up to 16 months post-randomization
Participants are followed for safety, tolerability, and clinical outcomes after completing treatment.
Visits for assessments during follow-up period
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
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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