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

Sponsor ID
323-201-00013
Clinicaltrials.gov ID
NCT07209761
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
+1 844-687-8522 or [email protected]
Recruiting
Sponsor ID
323-201-00013
Trial Details
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Age
14+ years
Therapeutic Area
  • Tuberculosis
    • Sex
    Female & Male
    Trial Dates
    Oct 2025 - May 2027
    Healthy Volunteers
    No
    • 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
    • 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

    Study 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.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: BPaQM
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    532
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Age ≥14 years
    • 2. Body weight ≥30.0 kg

    Exclusion Criteria

    • 1. Known/suspected resistance to BDQ, PMD, LZD, or QBS
    • 2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
    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

    Locations

    Location
    Status
    Location
    Capital Medical University - Beijing Chest Hospital
    Beijing, Beijing Municipality, China, 101100
    Status
    Recruiting
    Location
    Fuzhou Tuberculosis Prevention and Control Hospital of Fujian Province
    Fuzhou, Fujian, China, 350008
    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
    Shandong Public Health Clinical Center
    Jinan, Shandong, China, 250102
    Status
    Not yet recruiting
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