NCT05382312

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis

A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to measure the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics with GSK3036656 in combination with either delamanid or bedaquiline or BTZ-043, delamanid in combination with bedaquiline or standard of care for 14 days in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants will revert to the standard treatment (RIFAFOUR® e-275) once the study treatment (Day 1 to Day 14) has been completed.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	GSK3036656	GSK3036656 will be administered.
DRUG	Bedaquiline	Bedaquiline will be administered.
DRUG	Delamanid	Delamanid will be administered.
DRUG	RIFAFOUR e-275	RIFAFOUR e-275 will be administered.
DRUG	BTZ-043	BTZ-043 will be administered.

Timeline

• Start date: 2022-07-26
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2022-05-19
• Last updated: 2025-10-07

Locations

1 site across 1 country: South Africa