Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis

Summary

The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult participants with newly diagnosed, smear-positive, pulmonary drug sensitive tuberculosis (DS-TB).

The main questions the trial aims to answer are:

* What is the optimal dose of TBAJ876 to continue further in development.
* What is the bactericidal activity of bedaquiline with pretomanid and linezolid (B-Pa-L) compared to 2HRZE and TBAJ876-Pa-L over 8 weeks
* What is the efficacy and safety of the 26-week B-Pa-L regimen compared with the SOC (2HRZE/4HR) in participants with DS-TB.

Participants will be seen regularly during treatment (up to 26 weeks) and follow-up (52 weeks post treatment) for safety and efficacy assessments, including but not limited to:

* Safety labs, ECGs, vital signs, physical exams, PK sampling, neuropathy assessments and adverse event monitoring
* Sputum collection

Conditions

• Pulmonary TB
• Pulmonary Tuberculosis
• Drug Sensitive Tuberculosis

Interventions

DRUG

TBAJ-876

tablet

DRUG

Pretomanid

200 mg

DRUG

Linezolid

600 mg

DRUG

Bedaquiline

200 mg for 8 weeks followed by 100 mg for 18 weeks

DRUG

HRZE

Isoniazid (H) + rifampicin (R) + pyrazinamide (Z) plus ethambutol (E) fixed dose combination tablets dosed by weight

DRUG

HR

Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight

Sponsors & Collaborators

• Global Alliance for TB Drug Development

  lead OTHER

Principal Investigators

• Morounfolu Olugbosi, MD · TB Alliance

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-24

Primary Completion

2024-12-27

Completion

2026-06-30

FDA Drug

Yes

Countries

• Georgia
• Philippines
• South Africa
• Tanzania
• Uganda

Study Locations