A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberc… (NCT07209761) | Clinical Trial Compass
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
China532 participantsStarted 2025-10-16
Plain-language 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.
Who can participate
Age range14 Years
SexALL
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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
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
What they're measuring
1
Proportion of participants with unfavorable outcome.
Timeframe: From randomization to Month 12
2
Incidence of Grade ≥3 Treatment-Emergent Adverse Events, Serious Adverse Events, or Adverse Events Leading to Dose Reduction or Discontinuation (Safety and Tolerability).
Timeframe: From first dose to 2 weeks after end of treatment (Week 17 for BPaQM; Week 26 for BPaLM, BPaQ, BPaL)
Trial details
NCT IDNCT07209761
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.