Trial

Phase 2b/c, Multi-Arm, 2-Stage, Duration Randomized Trial of the Efficacy and Safety of Two to Four Months Treatment With Regimens Containing Bedaquiline, OPC-167832, and Sutezolid, Plus Either Pretomanid or Delamanid, (PBQS & DBQS) in Adults With Pulmonary Tuberculosis

Study Director
Start Date
8 / 2023
Trial Phase
Phase II
Trial Status
enrolling
Current Enrollment
514
Target Enrollment
Overview

Known as "PAN-TB XBQS" for the two regimens being evaluated (PBQS & DBQS), this multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, Quabodepistat (previously OPC-167832), and Sutezolid (DBQS) and Pretomanid, Bedaquiline, Quabodepistat, and Sutezolid (PBQS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).

Participant Group/Arm  Intervention/Treatment 
Experimental: Stage 1: Arm 1: DS-TB Participants receiving DBQS for 4 months (17 Weeks) Drug: Delamanid, Bedaquiline, Quabodepistat, and Sutezolid (DBOS)

  • D- 300 milligram (mg) once daily (QD) for treatment duration; B- 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S- 1200 mg QD for treatment duration
Experimental: Stage 1: Arm 2: DS-TB Participants receiving PBQS for 4 months (17 Weeks) Drug: Pretomanid, Bedaquiline, Quabodepistat, and Sutezolid (PBOS)

  • P- 200 mg QD for treatment duration; B- 400 mg QD for 2 weeks, 200 mg thrice weekly for remaining treatment weeks; O- 30 mg QD for treatment duration and S- 1200 mg QD for treatment duration
Experimental: Stage 1: Arm 3: DS-TB Participants receiving 2HRZE/4HR for 6 months (26 weeks)

Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E) - refers to standard regimen of 8 weeks of HRZE followed by 18 weeks of HR (2HRZE/4HR)

 Drug: Isoniazid, Rifampicin, Pyrazinamide, Ethambutol (HRZE)

  • Fixed dose combination (FDC) of 75 mg of isoniazid, 150 mg of rifampicin, 400 mg of pyrazinamide, and 275 mg of ethambutol (HRZE) (Standard of Care [SOC]). All the doses administered will be weight-based.
Related Links
PAN-TB Collaboration Announces the Start of a Phase 2 Clinical Trial to Evaluate Two Novel Tuberculosis Treatment Regimens
Registry Link
Developer Associations
Bill & Melinda Gates Medical Research Institute
Compound Associations
Bedaquiline
Quabodepistat (OPC-167832)
Sutezolid
Pretomanid
Delamanid