NCT07209761

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 532 (estimated)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 3, randomized, open-label, multicenter trial evaluating quabodepistat-containing regimens for rifampicin-resistant/multidrug-resistant (RR/MDR) pulmonary tuberculosis (TB). The study aims to enroll 532 participants aged 14 years and older. The study has two main cohorts: Fluoroquinolone-sensitive RR/MDR-TB (432 participants): * Experimental arm: BPaQM (bedaquiline, pretomanid, quabodepistat, moxifloxacin) for 4 months * Control arm: BPaLM (bedaquiline, pretomanid, linezolid, moxifloxacin) for 6 months Fluoroquinolone-resistant RR/MDR-TB (100 participants): * Experimental arm: BPaQ (bedaquiline, pretomanid, quabodepistat) for 6 months * Control arm: BPaL (bedaquiline, pretomanid, linezolid) for 6 months The primary efficacy endpoint is an unfavorable outcome by 12 months post-randomization. Secondary endpoints include time to unfavorable outcome, time to sputum culture conversion, and safety/tolerability assessments. Participants will be followed for 16 months post-randomization. The study will be conducted at approximately 40 sites in up to 12 countries. An independent Data Monitoring Committee and Endpoint Adjudication Committee will be used in the study. The trial aims to evaluate if quabodepistat-containing regimens can shorten treatment duration to 4 months for fluoroquinolone-sensitive RR/MDR-TB and provide a safer alternative to linezolid-containing regimens for both fluoroquinolone-sensitive and fluoroquinolone-resistant RR/MDR-TB.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-16
• Primary completion: 2027-05-28
• Completion: 2028-09-29
• First posted: 2025-10-07
• Last updated: 2026-02-10

Locations

33 sites across 8 countries: China, Georgia, Japan, Moldova, Peru, Philippines, South Africa, South Korea

Regulatory

• FDA-regulated drug study