A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis

Study Identifier:
323-201-00013
ClinicalTrials.gov Identifier:
NCT07209761
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
+49 1737 820 292 or [email protected]
Recruiting
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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
  • Age ≥14 years
  • Body weight ≥30.0 kg
  • Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
  • Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
  • Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
  • Chest radiograph consistent with active TB disease
  • Able to provide sputum sample
  • Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
  • Willing to have HIV test (unless previous positive result confirmed)
  • For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \<200 copies/mL, and CD4 count \>100 cells/mL
Exclusion Criteria
  • Known/suspected resistance to BDQ, PMD, LZD, or QBS
  • Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
  • Severe extrapulmonary TB
  • Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \<60 mL/min/1.73m², Hemoglobin \<8 g/dL, Platelets \<100,000 cells/mm³, WBC \<2.0×10⁹/L, ANC \<1000 cells/μL, and HbA1c \>9.0%
  • Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
  • Co-enrollment in other therapeutic trials
  • QTcF \>450 msec (males) or \>470 msec (females)
  • Clinically significant cardiovascular disorders
  • Bleeding disorders
  • Conditions interfering with X-ray or sputum assessment
  • Drug allergies/hypersensitivity to study medications
  • Pregnancy or breastfeeding
  • Positive drug screen (case-by-case assessment for some substances)
  • Serious mental disorders
  • Karnofsky score \<60
  • BMI \<16.0 kg/m²
  • Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
  • Pulmonary conditions other than TB (silicosis, fibrosis)
  • Active SARS-CoV-2 infection
  • Use of prohibited medications
  • Blood/plasma donation within 30 days
  • Current use of herbal remedies or traditional medicines

Protocol Summary

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.

Study Locations

Location
Status
Location
Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101100
Status
Not yet recruiting
Location
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518112
Status
Not yet recruiting
Location
Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)
Wuhan, Hubei, China, 430032
Status
Not yet recruiting
Location
The Second Hospital of Nanjing
Nanjing, Jiangsu, China, 210003
Status
Not yet recruiting
Location
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200040
Status
Not yet recruiting
Location
Shanghai Pulmonary Hospital - Pneumology
Shanghai, Shanghai Municipality, China, 200433
Status
Not yet recruiting
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© 2025 Otsuka America Pharmaceutical, Inc.
All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Age ≥14 years
  • Body weight ≥30.0 kg
  • Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
  • Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
  • Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
  • Chest radiograph consistent with active TB disease
  • Able to provide sputum sample
  • Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
  • Willing to have HIV test (unless previous positive result confirmed)
  • For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \<200 copies/mL, and CD4 count \>100 cells/mL
Exclusion criteria
  • Known/suspected resistance to BDQ, PMD, LZD, or QBS
  • Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
  • Severe extrapulmonary TB
  • Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \<60 mL/min/1.73m², Hemoglobin \<8 g/dL, Platelets \<100,000 cells/mm³, WBC \<2.0×10⁹/L, ANC \<1000 cells/μL, and HbA1c \>9.0%
  • Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
  • Co-enrollment in other therapeutic trials
  • QTcF \>450 msec (males) or \>470 msec (females)
  • Clinically significant cardiovascular disorders
  • Bleeding disorders
  • Conditions interfering with X-ray or sputum assessment
  • Drug allergies/hypersensitivity to study medications
  • Pregnancy or breastfeeding
  • Positive drug screen (case-by-case assessment for some substances)
  • Serious mental disorders
  • Karnofsky score \<60
  • BMI \<16.0 kg/m²
  • Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
  • Pulmonary conditions other than TB (silicosis, fibrosis)
  • Active SARS-CoV-2 infection
  • Use of prohibited medications
  • Blood/plasma donation within 30 days
  • Current use of herbal remedies or traditional medicines

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