Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis

Summary

This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).

Conditions

• Pulmonary Tuberculosis

Interventions

DRUG

Pretomanid, Bedaquiline, OPC-167832, 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

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.

DRUG

Delamanid, Bedaquiline, OPC-167832, 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

DRUG

Pretomanid or Delamanid, Bedaquiline, OPC-167832, and Sutezolid (XBOS)

X - Pretomanid 200 mg QD for treatment duration OR Delamanid 300 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

DRUG

Isoniazid and Rifampicin (HR)

Fixed dose combination (FDC) of 75 mg of isoniazid and 150 mg of rifampicin (HR) (Standard of Care \[SOC\]). All the doses administered will be weight-based.

Sponsors & Collaborators

• Global Alliance for TB Drug Development

  collaborator OTHER

• Janssen Pharmaceuticals

  collaborator INDUSTRY

• Otsuka Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Gates Medical Research Institute

  lead OTHER

Principal Investigators

• Gates MRI · Gates Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-26

Primary Completion

2025-02-06

Completion

2025-02-06

Countries

• Philippines
• South Africa

Study Locations