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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥14 years 2. Body weight ≥30.0 kg 3. Able to provide written willing to sign a consent form (if under 18, requires both participant assent and parent/guardian consent) 4. Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high') 5. Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test 6. Chest radiograph consistent with active TB disease 7. Able to provide sputum sample 8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose 9. Willing to have HIV test (unless previous positive result confirmed) 10. 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 Who Should NOT Join This Trial: 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 3. Severe extrapulmonary TB 4. 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% 5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment 6. Co-enrollment in other therapeutic trials 7. QTcF \>450 msec (males) or \>470 msec (females) 8. Clinically significant cardiovascular disorders 9. Bleeding disorders 10. Conditions interfering with X-ray or sputum assessment 11. Drug allergies/hypersensitivity to study medications 12. Pregnancy or breastfeeding 13. Positive drug screen (case-by-case assessment for some substances) 14. Serious mental disorders 15. Karnofsky score \<60 16. BMI \<16.0 kg/m² 17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥14 years 2. Body weight ≥30.0 kg 3. Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent) 4. Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high') 5. Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test 6. Chest radiograph consistent with active TB disease 7. Able to provide sputum sample 8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose 9. Willing to have HIV test (unless previous positive result confirmed) 10. 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: 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 3. Severe extrapulmonary TB 4. 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% 5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment 6. Co-enrollment in other therapeutic trials 7. QTcF \>450 msec (males) or \>470 msec (females) 8. Clinically significant cardiovascular disorders 9. Bleeding disorders 10. Conditions interfering with X-ray or sputum assessment 11. Drug allergies/hypersensitivity to study medications 12. Pregnancy or breastfeeding 13. Positive drug screen (case-by-case assessment for some substances) 14. Serious mental disorders 15. Karnofsky score \<60 16. BMI \<16.0 kg/m² 17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver) 18. Pulmonary conditions other than TB (silicosis, fibrosis) 19. Active SARS-CoV-2 infection 20. Use of prohibited medications 21. Blood/plasma donation within 30 days 22. Current use of herbal remedies or traditional medicines

Treatments Being Tested

DRUG

BPaQM

Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 15 weeks + Pretomanid 200 mg QD for 17 weeks + Quabodepistat 30 mg once daily for 17 weeks + Moxifloxacin 400 mg once daily for 17 weeks

DRUG

BPaLM

Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks + Moxifloxacin 400 mg once daily for 26 weeks

DRUG

BPaQ

Bedaquiline 400 mg once daily for 2 weeks then 100 mg once daily for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Quabodepistat 30 mg once daily for 26 weeks

DRUG

BPaL

Bedaquiline 400 mg once daily for 2 weeks then 200 mg thrice a week for 24 weeks + Pretomanid 200 mg QD for 26 weeks + Linezolid 600 mg once daily for 26 weeks

Locations (20)

Capital Medical University - Beijing Chest Hospital
Beijing, Beijing Municipality, China
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Wuhan Institute of Tuberculosis Control (Wuhan Pulmonary Hospital)
Wuhan, Hubei, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Shanghai Pulmonary Hospital - Pneumology
Shanghai, Shanghai Municipality, China
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, China
National Center for Tuberculosis and Lung Disease
Tbilisi, Georgia
Japan Anti-Tuberculosis Association Fukujuji Hospital
Kiyose, Tokyo, Japan
IMSP Institutul de Ftiziopneumologie Chiril Draganiuc - Phthisiopneumology
Chisinau, Chisinau City, Moldova
Socios en Salud Sucursal Peru
La Molina, Lima region, Peru
Centro de Investigación del Hospital de Emergencias de Villa el Salvador
Villa El Salvador, Lima region, Peru
Hospital Sergio E. Bernales
Lima, Peru
Silang Specialist Medical Center
Silang, Cavite, Philippines
Jose B. Lingad Memorial Regional Hospital
San Fernando City, Central Luzon (Region III), Philippines
Tropical Disease Foundation
Makati City, National Capital Region, Philippines
Lung Center Of The Philippines
Quezon City, National Capital Region, Philippines
Synergy Biomed Research Institute
East London, Eastern Cape, South Africa
Isango Lethemba TB Res Unit (CHRU) - Jose Pearson TB Hospital
Port Elizabeth, Eastern Cape, South Africa
The Aurum Institute - Tembisa Hospital Clinical Research Centre
Johannesburg, Gauteng, South Africa
Clinical HIV Research Unit (CHRU) - Helen Joseph Hospital
Johannesburg, Gauteng, South Africa