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A Study of Quabodepistat-containing Regimen for the Treatment of Drug-resistant Pulmonary Tuberculosis
Study Identifier:
323-201-00013
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
Will Be Recruiting
Study Details
Medical Condition
- Tuberculosis
Study Drug
- Drug: BPaQM
- Drug: BPaLM
- Drug: BPaQ
- Drug: BPaL
Date
Oct 2025 - May 2027
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 14+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Inclusion Criteria:
- Age 14 years or older.
- Body weight ≥ 30.0 kg.
- Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra semi-quantitative result of 'low', 'medium', or 'high' on the screening sputum sample.
- Resistant to at least rifampicin by Xpert MTB/RIF Ultra test.
- Chest radiograph consistent with evidence of active TB disease.
- Able to provide a sputum sample.
- For participants of childbearing potential: agreement to use 2 different effective methods of birth control.
- Willing to have an HIV test.
- For participants living with HIV: on stable antiretroviral regimen for at least 3 months, viral load \< 200 copies/mL, and CD4 count \> 100 cells/mL.
- Exclusion Criteria:
- Known or suspected resistance to any of the drugs administered in the treatment interventions.
- Prior treatment with bedaquiline, pretomanid, linezolid, delamanid, quabodepistat, or DprE1 inhibitors for 1 or more months within the past 3 months.
- Clinical evidence of Severe extrapulmonary TB.
- Specific laboratory test results outside of defined ranges (e.g., ALT or AST \> 2.5 x ULN, total bilirubin \> 1.5 x ULN).
- Pre-existing peripheral neuropathy Grade 1 or higher, optic neuritis, or visual impairment.
- QTcF \> 450 msec in male participants (\> 470 msec in female participants).
- History of clinically significant cardiovascular disorders.
- Known bleeding disorders or family history of bleeding disorders.
- Pregnant or breastfeeding women.
- Karnofsky score \< 60.
- Body mass index \< 16.0 kg/m2.
- Evidence of clinically significant metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, or liver conditions.
- Active SARS-CoV-2 infection at screening.
Protocol Summary
This study aims to assess quabodepistat-based treatment regimen 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.
Study Locations
Location
Status
Location
Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101100
Status
N/A
Location
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518112
Status
N/A
Location
Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)
Wuhan, Hubei, China, 430032
Status
N/A
Location
The Second Hospital of Nanjing
Nanjing, Jiangsu, China, 210003
Status
N/A
Location
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040
Status
N/A
Location
Shanghai Pulmonary Hospital - Pneumology
Shanghai, Shanghai Municipality, China, 200433
Status
N/A
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© 2025 Otsuka America Pharmaceutical, Inc.
All rights reserved.
July 2025 01US25EUC0279
Requirements information
Inclusion criteria
- Inclusion Criteria:
- Age 14 years or older.
- Body weight ≥ 30.0 kg.
- Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra semi-quantitative result of 'low', 'medium', or 'high' on the screening sputum sample.
- Resistant to at least rifampicin by Xpert MTB/RIF Ultra test.
- Chest radiograph consistent with evidence of active TB disease.
- Able to provide a sputum sample.
- For participants of childbearing potential: agreement to use 2 different effective methods of birth control.
- Willing to have an HIV test.
- For participants living with HIV: on stable antiretroviral regimen for at least 3 months, viral load \< 200 copies/mL, and CD4 count \> 100 cells/mL.
- Exclusion Criteria:
- Known or suspected resistance to any of the drugs administered in the treatment interventions.
- Prior treatment with bedaquiline, pretomanid, linezolid, delamanid, quabodepistat, or DprE1 inhibitors for 1 or more months within the past 3 months.
- Clinical evidence of Severe extrapulmonary TB.
- Specific laboratory test results outside of defined ranges (e.g., ALT or AST \> 2.5 x ULN, total bilirubin \> 1.5 x ULN).
- Pre-existing peripheral neuropathy Grade 1 or higher, optic neuritis, or visual impairment.
- QTcF \> 450 msec in male participants (\> 470 msec in female participants).
- History of clinically significant cardiovascular disorders.
- Known bleeding disorders or family history of bleeding disorders.
- Pregnant or breastfeeding women.
- Karnofsky score \< 60.
- Body mass index \< 16.0 kg/m2.
- Evidence of clinically significant metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, or liver conditions.
- Active SARS-CoV-2 infection at screening.